Drug Law Blog

FDA Weighs Pulling Nyquil off Shelves to Address Acetaminophen Overdose

The Wall Street Journal's Health Blog notes that the FDA is mulling whether to pull Nyquil off the pharmacy shelf to address the problem of acetaminophen overdose. Acetaminophen (which is called paracetamol by folks in other countries) can cause liver failure in high doses, something that the public still apparently has not grasped. The FDA "cites one study that suggested acetaminophen overdoses were associated with 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year in the U.S. during the 1990s."

Call me crazy, but if the problem is acetaminophen overdose, maybe the first product to take off the shelf should be Tylenol, not Nyquil. Tylenol is just straight acetaminophen, rather than a syrupy blend of various substances that's found in Nyquil.

FDA Tobacco Regs Become Law

Remarkable stuff. Some background here.

Senate Approves Groundbreaking Tobacco Regulation

After years and years of proposals that went nowhere, the Senate has actually passed a measure today that would bring tobacco under FDA regulation. The Washington Post reports:

The Senate approved landmark legislation today that would give the government sweeping new power to oversee tobacco, a centuries-old product used by 20 percent of Americans yet largely unregulated in this country.

The bipartisan measure, approved by a margin of 79 to 17, largely mirrors a measure passed by the House last month. The House will now review the Senate's version before a bill is sent to President Obama, a smoker who has struggled to quit and who has said he is eager to sign the bill into law. It comes 50 years after the surgeon general first warned of the health effects of tobacco.

Wow.

FDA and Tobacco - Yet Another Push for Regulation

Slowly trying to get this blog creaking back into gear, things having eased up slightly for me.

Congress is talking yet again about having FDA regulate tobacco.  Kind of like they were talking about it back in March and back in July of 2008 and, uh, back in August of 2007.

In other words, it's an interesting idea whose time never seems to come, for one reason or another.

Another Push for FDA Regulation of Tobacco

Via the Washington Post:

In what appears to be the best chance since public health groups started pushing for it in the 1970s, Congress is poised to regulate tobacco, a product linked to 1,200 deaths each day but sold largely unfettered for centuries.

Legislation that the House Energy and Commerce Committee will take up today would place tobacco under the control of the Food and Drug Administration. Among other things, the bill would restrict the ways tobacco companies market cigarettes, require them to disclose the ingredients in their products and place larger warning labels on packages, and give the FDA the authority to require the removal of harmful chemicals and additives from cigarettes.

Such a proposal has been raised and rejected before. In fact, the House passed a bill on this point in July of last year, but nothing came of it.

Related Posts:

Bush Threatens Veto of Bill That Would Allow FDA Regulation of Tobacco 7/23/08

Dangerous and Targeted at Youth? Sounds Like Legal, Non-FDA Regulated Tobacco! 7/17/08

FDA Tobacco Regulation Inches Closer 8/3/07

House Approves Tobacco Regulation

Remarkable news from the New York Times:

The House of Representatives overwhelmingly approved legislation on Wednesday that would for the first time give the Food and Drug Administration the power to regulate tobacco products.

Citing the long history of warnings about the dangers of smoking, Representative John D. Dingell, chairman of the Energy and Commerce Committee, said that it was hard to believe that the federal government had not yet regulated the tobacco industry.

Yeah, it is kind of hard to believe. And it's even harder to believe that Bush has promised to veto this legislation.

Related Posts:

Bush Threatens Veto of Bill That Would Allow FDA Regulation of Tobacco 7/23/08

Dangerous and Targeted at Youth? Sounds Like Legal, Non-FDA Regulated Tobacco! 7/17/08

FDA Tobacco Regulation Inches Closer 8/3/07

WSJ on the FDA Tobacco Regulation Bill

The Wall Street Journal has a report today on the progress of the bill that would bring tobacco under the FDA's regulatory power -- a measure that seems to be gaining a little more momentum than it initially seemed to have. Reporter Alicia Mundy notes that "supporters say they believe the bill may have as many as 320 votes in the House, more than enough for passage. A vote could come as soon as Wednesday."  However, the bill's prospects in the Senate and the White House look less promising.

(Above: Ashtray monument.)

Mundy also notes that the current bill exempts menthol cigarettes, an exception that some lawmakers apparently think is essential to its passage.

Related Posts:

Bush Threatens Veto of Bill That Would Allow FDA Regulation of Tobacco 7/23/08

Dangerous and Targeted at Youth? Sounds Like Legal, Non-FDA Regulated Tobacco! 7/17/08

FDA Tobacco Regulation Inches Closer 8/3/07

Bush Threatens Veto of Bill That Would Allow FDA Regulation of Tobacco

From the July 23, 2008 issue of The New York Times:

In its sharpest criticism yet of the tobacco legislation pending in Congress, the Bush administration has said it “strongly” opposes the effort to give the Food and Drug Administration regulatory authority over tobacco.

The criticism came Monday in a letter by Michael O. Leavitt, the secretary of health and human services, which some saw as a signal that a veto would be likely if the legislation cleared the House and Senate.

It's a strange system we have. The FDA gets freaked out about salmonella in tomatoes that threaten the health of a handful of people. Meanwhile it studiously avoids regulating cigarettes, the number one cause of preventable death in America. And the Bush administration is so opposed to taking some sort of step toward rectifying this issue that it will actually veto legislation to change the status quo if Congress actually manages to pass a law.

Bizarre.

Dangerous and Targeted at Youth? Sounds Like Legal, Non-FDA Regulated Tobacco!

New reports indicate that tobacco companies manipulated the level of menthol in cigarettes specifically to hook young users.

Scientists from the Harvard School of Public Health scoured thousands of pages of industry documents from the 1980s, '90s, and more recently, and commissioned laboratory tests of menthol cigarettes to uncover a strategy that was decades in the making.

The researchers found that tobacco companies embrace a Goldilocks approach when launching brands: Add too little menthol, which has an effect akin to anesthesia, and tobacco retains its intense bite. Add too much, and first-time smokers are overwhelmed. Add just the right amount, and cigarettes become powerfully seductive.

A 1987 internal memo from R.J. Reynolds Tobacco Co., maker of the menthol Salem cq brand, succinctly summarized the benefits of low-level menthol cigarettes, as "Smoother more refreshing tobacco taste." Such a product, the memo declared, would be a "proven winner" targeted at 18- to 24-year-olds.

Smoking is the leading cause of preventable death in the United States. Cigarettes are not regulated by the FDA. Why? Because the FDA thinks it would be "risky" to regulate. It's much better, apparently, to let tobacco companies regulate themselves -- the better to develop new ways of hooking users.

How does this compare to our approach to marijuana, cocaine, and other "illegal" drugs? Where is the correlation between the health risk posed by the drug and the intensity of the regulatory response?

Armentano on the Relationship Between Medical Marijuana and Pharmaceuticals

Paul Armentano has a post at the NORML blog that addresses my absolute favorite spot in the law: that awkward no-man's-land between criminal drug law and pharmaceutical administrative law, which is where the demonized, criminalized plant marijuana, which will drive you insane and destroy society, turns into a totally legitimate, FDA-approved pharmaceutical drug like Marinol, which can be dispensed by pharmacies and consumed by law-abiding grandmas while watching re-runs of Laverne and Shirley.

Armentano notes:

Big Pharma is busily applying for — and has already received — multiple patents for the medical properties of pot. (The US government has too, but that’s a different story all together.) These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain’s endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper, “The endocannabinoid system as an emerging target of pharmacotherapy,” which concluded, “The growing interest in the underlying science has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004.”

In other words, at the same time the American Medical Association is proclaiming that pot has no established medical value, Big Pharma is in a frenzy to bring dozens of new, cannabis-based medicines to market.

Interestingly, Armentano argues against the frequently asserted notion that big pharma is somehow conspiring to keep the plant form of marijuana illegal.

The Broken FDA

A couple news reports are discussing a study suggesting that the FDA has serious problems as the result of funding cuts over the last several years.

The report was prepared by the FDA Subcommittee on Science and Technology, and it's available here (pdf).

FDA Mulls "Behind the Counter" Status for Some Drugs

The FDA is considering increasing the accessibility of some drugs that are now available only with a prescription, classifying them as "behind the counter" drugs that can be obtained simply by having a conversation with a pharmacist, the Los Angeles Times reports.

Reporter Daniel Costello writes that the plan

would let consumers purchase routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription -- as long as they discuss it with a pharmacist first.

Pharmacists and drug companies like the idea; doctors think it's dangerous. If approved, the drug classification could go into effect as early as next year.

...

[A] much wider selection of behind-the-counter medications is available in Australia, Canada and several European countries. Several other countries are considering similar plans.

I want see the reaction to this from Pharmalot, a blog that is much more oriented to the pharmaceutical industry than is this one, but so far there's nothing.

FDA Gets a Boost

The New York Times reports that Congress has passed a bill that "is expected to give federal drug regulators significantly more money and power to ensure the safety of the nation’s drug supply."

Reporter Gardiner Harris gives a few highlights from the bill, but the article is very general in its descriptions, and it's unclear to me how it relates to the Kennedy-Enzi bill that was approved by the Senate in May and described in the Times as being  "the most important legislation for F.D.A. in at least 10 years and, probably, forever on issues of drug safety." Pharmalot has helpfully posted the pdf of the actual bill, but that's a little too much information for my primitive monkey brain.

At any rate, here is what Harris writes:

The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers.

...

The legislation passed Wednesday does nothing to address calls by some patient advocacy groups for the agency to allow the sale of some drugs while they are still being researched.

...

Drug makers would be required to post publicly the results of all clinical trials involving approved medicines. This provision is in response to controversy about a set of clinical trials kept secret by the industry that revealed that antidepressants increased the risks of suicide in teenagers while doing little to treat their depression.

The bill would also grant the agency the power to require drug makers to undertake clinical trials of medicines that the agency has already approved and to fine those who fail to do so. Few drug makers have followed through on past promises to undertake such trials, and the drug agency has done almost nothing about these failures.

The legislation would also grant the agency the authority to force drug makers to change the labels on their products, and it would give the agency the power to limit the distribution of certain drugs.

It would require the agency to reduce the number of conflict-of-interest waivers it grants to experts who serve on its advisory boards.

Pharmalot's analysis of the bill is here.

An Abigail Alliance Interview

The Abigail Alliance For Better Access to Developmental Drugs recently lost the en banc rehearing of its argument in the DC Circuit, but this interesting case might well end up ultimately being decided by the Supreme Court. The following is a transcript of a short conversation I had with Scott Ballenger, the attorney who worked on the Alliance's appeal.

Is the Abigail Alliance planning to petition to see if the Supreme Court will take this case?

Yeah, absolutely, and I suspect we will hear one way or another from the Supreme Court in February, and then by that point the court’s document is full for that spring. So if the court took the case it would probably be heard in the fall of 2008.

Do you think there’s anything in this case that would hook the imagination of the Court such that they would want to hear it?

Yeah I do. I think there are a lot of things. (More.)

DC Circuit Rejects Abigail Alliance Argument on Drug Access

The en banc DC Circuit today rejected the argument that there is a due process right to access certain types of experimental drugs.

In footnote 5 of the opinion, the majority responds to the dissent regarding the scope of the right that is being asserted in this case:

The dissent has recast the Alliance’s proposed right away from the terms used in its briefs and oral argument—a right to access investigational new drugs—into a right “to try to save one’s life,” which has “its textual anchor in the right to life [expressed in the Fifth Amendment].” Dissent at 2-3. Regardless of how it is described, we must examine the proposed right under Glucksberg, which specifically cautions against the type of broad generalization the dissent now employs. See Glucksberg, 521 U.S. at 721 (requiring a “‘careful description’ of the asserted fundamental liberty interest”). If the asserted right is so broad that it protects a person’s efforts to save his life, it might subject to strict scrutiny any government action that would affect the means by which he sought to do so, no matter how remote the chance of success. The Supreme Court rejected a similar attempt to broadly define the right at issue in Reno v. Flores when it refused to accept the petitioner’s definition as the “freedom from physical restraint” and instead cast the right as the “right of a child who has no available parent, close relative, or legal guardian, and for whom the government is responsible, to be placed in the custody of a willing-and-able private custodian rather than of a government-operated or government-selected child-care institution.” Reno v. Flores, 507 U.S. 292, 302 (1993). The dissent suffers from the same flaw in arguing that this is about the right to save one’s life, because, in the end, this case is about the right to access experimental and unproven drugs in an attempt to save one’s life, which we conclude under Glucksberg is not deeply rooted in our Nation’s history and traditions. By describing too broadly at the outset a proposed right that will cover the Alliance’s more narrow claim, the dissent fails Glucksberg’s threshold requirement of a carefully described right. We need not pursue the arguments that follow that initial misstep.

Emphasis added.

I had noted the importance of the way the right was described in this earlier post. The dissent in today's case says the majority's perspective on this issue betrays "a flawed conception of the right claimed by the Abigail Alliance for Better Access to Developmental Drugs and a stunning misunderstanding of the stakes." 

The court's opinion contains an interesting description of early American drug regulation practices, starting on p. 16. Additionally, it touches on the issue of criminal drug controls, using that issue to attack the Alliance's position:

[O]ne might argue that, because Congress did not significantly regulate marijuana until 1937, relatively late in the constitutional day, see Gonzales v. Raich, 545 U.S. 1, 11 (2005), there must be a tradition of protecting marijuana use. Because Congress did not regulate narcotics until 1866 when it heavily taxed opium, a drug created long before our Nation’s founding, see United States v. Moore, 486 F.2d 1139, 1215-16, 1218 n.50 (D.C. Cir. 1973) (Wright, J., dissenting), it must be that individuals have a right to acquire and use narcotics free from regulation. . . .  But this is most certainly not the law. A prior lack of regulation suggests that we must exercise care in evaluating the untested assertion of a constitutional right to be free from new regulation. But the lack of prior governmental regulation of an activity tells us little about whether the activity merits constitutional protection: “The fact that powers long have been unexercised well may call for close scrutiny as to whether they exist; but if granted, they are not lost by being allowed to lie dormant, any more than nonexistent powers can be prescripted by an unchallenged exercise.”

The dissent, too, musters a bunch of historical arguments about the right to defend one's own life at common law, and these seem just about as compelling as the regulatory arguments put forth by the majority. All of which goes to show, in my opinion, that whether something is a right “deeply rooted in this Nation’s history and tradition” is a standard that is extremely malleable. The outcome of such a test has far less to do with history than either side would like to pretend and far more to do with the pragmatic considerations motivating each side.

At any rate, given the way the majority defines the right, it's no surprise that the court applies rational basis review to the FDA regulatory regime and concludes that the regime survives that review.

FDA Tobacco Regulation Inches Closer

A bill has survived a Senate committee vote. Wired News has coverage. So does the Boston Globe.

The New York Times has an op-ed on the bill today from Patrick Basham of the Democracy Institute and the Cato Institute. Basham makes some points that may be valid, such as the potential for this bill to unfairly benefit Philip Morris, and he also raises a version of my favorite bad drug policy argument:

by setting regulatory standards for reduced-risk cigarettes, the F.D.A. would send a message to both smokers and nonsmokers that smoking is really not very risky.

Yes indeed, it's the old "we have to send the right message" argument, which is so familiar to us from its relentless recycling in the context of criminal drug policy. "We have to send the right message" is the argument that the callous bureaucrats at the Office of National Drug Control Policy use to justify opposing needle exchange in favor of allowing people to die from HIV and hepatitis instead. It's the argument that Dennis Hastert has used to argue that medical marijuana must be stopped at all costs. And it makes even less sense in the context of tobacco than it does when it comes to needle exchange and medical marijuana because cigarettes are already freely available and  minimally regulated. The suggestion that we will "send the message" that cigarettes are healthy if we regulate them more truly boggles my mind.

(Below: Senator Edward Kennedy, sponsor of the Senate bill to bring tobacco under the FDA's regulatory control. Photo from the Boston Globe/Getty Images, photographer Alex Wong.)

Boston Globe on Medical Self Defense and the Abigail Alliance

The Boston Globe has an interesting piece on the movement to assert the right of "medical self-defense" and on the Abigail Alliance's case still-pending before the en banc DC Circuit Court of Appeals.

It's a complicated issue in part because of the difficulty of drawing the limits on the assertion of such a right. As author Christopher Shea notes, some scholars (including Eugene Volokh) would argue that medical defense would include even the right to take ethically challenging actions like selling organs, while others would suggest that it involves the right to use medical marijuana. A more narrow view, however, might simply argue that the regulatory regime of the federal government should not stand in the way of using drugs that have received at least preliminary approval for use in human subjects. Shea quotes a bioethicist who suggests that any steps down this road will send society "back to the snake-oil days." But I tend to think that the consequences of allowing greater freedom in this area would be less extreme that we might suppose.

(Hat tip: The Volokh Conspiracy.)

FDA Pushes For Impurity Test For Supplements

The Washington Post notes that the FDA plans to require manufacturers of dietary supplements to test their products for impurities: "If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or seek criminal charges."

Supplements are sort of a gray area in the American drug regulatory regime. They're neither fish nor fowl, neither food nor drug, and they aren't nearly as tightly regulated as conventional drugs. The WaPo quotes groups like Public Citizen, who argue that the structure around supplements is an "enormous deficiency in the law." But another way of looking at it is that this "enormous deficiency" is actually a boon for consumers, who can do their own research and access remedies that they find helpful for themselves. Both perspectives have a certain amount of validity, in my opinion.

The FDA's press release on this issue is here.

Xyrem: Fighting Off the Taboo of Schedule I

The New York Times reports today on Palo Alto-based Jazz Pharmaceuticals, which makes a drug called Xyrem to treat narcolepsy. The striking thing about this drug: it's also the Schedule I substance gamma hydroxybutyrate, better known as the party/date rape drug GHB, even better known as George Michael's nemesis.

Why is that interesting? Just because Schedule I substances aren't supposed to have any medical use. And because the FDA explicitly invoked the fact that marijuana is a Schedule I substance in its April 2006 "inter-agency advisory" that smoked marijuana could not possibly be a medicine. Turns out, being on Schedule I doesn't really determine whether something can be a medicine -- even when the drug in question has recreational uses.

As a side note, I'm betting that the folks at Jazz are grinding their teeth today as the press talks about their product as a "date rape drug." It's unfortunate that the good "news hook" is something salacious and irrelevant, when the far more important issue is whether this drug can help people.

(Hat tip: Pharmalot.)

Section 252: Senator Coburn Pushes for FDA Regualtion of Medical Marijuana

Senator Tom Coburn of Oklahoma is pushing for FDA regulation of medical marijuana, and has included language to that effect in Section 252 of a bill passed by the Senate today that simply reauthorizes the FDA.

According to Senator Coburn's website, Section 252 reads as follows:

SEC. 252. MEDICAL MARIJUANA.

The Secretary shall require that State-legalized medical marijuana be subject to the full regulatory requirements of the Food and Drug Administration, including a risk evaluation and mitigation strategy and all other requirements and penalties of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective reviews, approval, sale, marketing, and use of pharmaceuticals.

This is really an interesting issue, and there's a lot going on. It's all pretty academic at this point because the House is not likely to approve comparable language. But what if it did?

First of all, could Congress order the FDA to regulate medical marijuana, even if the FDA didn't want to? Remember, the FDA is on record asserting that it does "not support the use of smoked marijuana for medical purposes." Given that position, and given that the FDA has also rejected the notion that it should be involved in regulating cigarettes, does Congress have the power to tell the FDA how to do its job at this level of detail?

Second, how would the FDA actually react? Would it fight such a provision? Would it go along with it?

And finally, would it make any sense as a matter of federal policy? How could marijuana simultaneously be a Schedule I drug with no accepted medical uses and a drug that is subject to full FDA review as a pharmaceutical?

At any rate, it's a very interesting strategic move by Senator Coburn. In an article on The Politico, medical marijuana activists are paraphrased as saying that Coburn "clearly intended to shut down medical marijuana cooperatives" with this measure. That might be true, and it might create a short-term setback for the medical marijuana movement. But it's a double-edged sword: if the FDA really were to begin to regulate medical marijuana, it would ultimately help the cause of medical marijuana far more than it would hurt it, because it would bring it the commodity it is most critically lacking: a sense of institutional legitimacy.

Senate Approves Kennedy-Enzi FDA Bill

From an LA Times piece by Ricardo Alonso-Zaldivar in today's paper:

The Senate today approved a major overhaul of the nation's drug safety system, designed to fix the problems revealed by the withdrawal of the painkiller Vioxx and other recent lapses.

The bill would create a computerized system to scan medical and pharmacy records for indicators of trouble with new medications, and give the Food and Drug Administration stronger powers to require drug makers to take remedial action when problems arise.

The 93-1 vote came after about a week of debate that centered on how to find a balance between delivering promising new drugs to doctors and patients while also protecting the public from rare side effects that may not be immediately evident. Sen. Bernard Sanders, the Vermont independent who is a strong critic of the pharmaceutical industry, voted no.

The legislation "will bring the work of the FDA into the 21st century," said Sen. Edward M. Kennedy, D-Mass., who coauthored the bipartisan bill with Sen. Michael Enzi, R-Wyo.

"At the heart of our proposal is a modern system for improving patient safety -- not through additional layers of bureaucracy, but through a flexible structure that emphasizes … surveillance," Kennedy said.

In New York Times coverage of this measure last week, officials suggested that this bill was "the most important legislation for F.D.A. in at least 10 years and, probably, forever on issues of drug safety."

Cocaine Drink Pulled

The FDA's scrutiny of the energy drink called "Cocaine," which I noted last month, has now resulted in the drink being pulled off the market by the manufacturer, according to the LA Times. The manufacturer plans "to sell the drink under a new name," the Times reports.

Pete over at Drug WarRant jokes that perhaps "ice" will be the next product the FDA tries to shut down, on the grounds that "ice" is a slang term for methamphetamine. Another candidate that might be considered: Skittles, a product whose name these days is virtually synonymous with recreational use of dextromethorphan by teens.

(Above: the now-defunct energy drink Cocaine. Below: Skittles. The next to fall?)

(Hat tip: Drug WarRant.)

The Politics of Side Effects: Marijuana Versus Antidepressants

Two types of drugs have been in the news in the last couple of days because of concerns about the side effects they can produce in small populations of users.  In both cases, the side effect is fairly rare, but in both cases the side effect is serious.

The first is marijuana. A new study from researchers in London suggests that the use of marijuana is associated with changes in brain activity that may be linked to the development of psychosis or schizophrenia in a small percentage of people who use that drug heavily. A second study, from Yale, suggests that the use of marijuana may worsen schizophrenic symptoms in individuals who already have such symptoms but are otherwise stable.  Some of the folks in the drug policy world have suggested that the concerns raised by these studies may be rather exaggerated, but I don't think it makes any sense to downplay the concerns about such side effects at a time when more and more people are considering using marijuana for medical purposes. If it's a real concern, then fine. People should be aware of it.

The second type of drug that has some serious side effect concerns is antidepressants. The FDA just said this week that manufacturers of all antidepressants must put stronger warnings on their products about the risk that the drugs will encourage "suicidal thoughts and behavior" in people age 18 to 24.  These kinds of drugs already had to carry a warning about the risk of encouraging suicidal thoughts and behavior in kids and teenagers, and now there seems to be an understanding that the risks are somewhat broader than initially thought.

Two types of drugs, each one posing a risk of harm to small percentages of users, each promising benefits to
much larger percentages of users. How should they be treated? One option might be to ban them both, and indeed it wouldn't be too difficult to take some of the standard "protect the children" rhetoric that is used in the War on Drugs and turn it against the manufacturers of antidepressants. But perhaps the use of a warning label is a more reasonable solution, in spite of our concern about preventing suicide, because we value the benefits of antidepressants.

What if marijuana was required to carry a warning label, so that individuals who already have schizophrenic symptoms would realize that the use of that drug could be problematic for them? Couldn't the regulatory tools that we use to encourage safety around antidepressants be useful when it comes to marijuana? And given that 12 states now permit the medical use of marijuana, isn't it time for the FDA to start developing some guidelines of this nature?

Kennedy-Enzi: Either a Pivotal Moment in FDA History ... Or Not.

The New York Times noted yesterday (5/1/07) that the Senate is considering a measure that would increase fees to drug companies seeking approval for drugs and "provide more money to track the safety of drugs after they have reached consumers and more authority to force drug manufacturers to complete promised safety studies. It would also renew requirements and incentives for pharmaceutical companies to ensure that their products are safe for children."

The Times quotes a couple officials who describe this bill, called the Kennedy-Enzi bill for simplicity's sake, as being a Great Big Deal -- "a pivotal moment in F.D.A.’s history," "the most important legislation for F.D.A. in at least 10 years and, probably, forever on issues of drug safety," etc. I'm not sure I grasp why this is such a dramatic change. In another area of law, I would think this type of thing might be called a modest increase in administrative oversight. But perhaps the article just doesn't capture what's so critical about Kennedy-Enzi.

FDA Concerned About "Cocaine," The Drink

Back in December I noted the dispute over whether the creators of the energy drink named "Cocaine" should be allowed to trademark their brainchild. There was opposition to granting the trademark because of the "immoral and scandalous" nature of the name.

Well, Cocaine (the drink) is facing a new legal flap, this time because the FDA asserts that the drink is being marketed "as an alternative to an illicit street drug." Moreover, the drink contains the chemical inositol, which the marketers of Cocaine (the drink) have been saying helps reduce blood cholesterol, produces a calming effect, and so on.  These claims, the FDA says, amount to an assertion that the drink is a "drug" intended to treat certain diseases, rather than a dietary supplement.

The manufacturers of Cocaine note that many other energy drinks also contain inositol. Over on the website for Rockstar energy drinks, for example, one can learn than five out of the six flavors of Rockstar drinks contain the substance (Rockstar Zero Carb is inositol-free).

New Labels for Ambien, Other Sleep Meds

Ambien and other sleep medications must carry labels warning about the risk of odd behaviors like sleep-eating and sleep-driving, the FDA said today.

This blog previously has written previously about Ambien-related weirdness, including its role in Rep. Patrick Kennedy's strange auto mishap last summer.

ASA Sues DHS, FDA Re Statements On Medical Marijuana

Finally the other shoe drops in a story I noted back in June of 2006 and that actually began in 2004: Americans for Safe Access has followed through on its threat to sue the Department of Health and Human Services and the FDA for failing to change their characterization of the science around medical marijuana.

ASA argues that the statements these federal agencies have made about medical marijuana violate a law called the Data Quality Act that is intended to ensure the accuracy of information disseminated by the feds. Joe Elford, Chief Counsel for ASA, is quoted in a press release from the group saying "The FDA position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science."

As I note in the lede of this item, ASA had actually threatened to sue back last June, and for some reason the follow-through did not happen until now. But it seems like an interesting and unconventional legal strategy. Over at Hit & Run, Jacob Sullum notes that "ASA's innovative use of the Data Quality Act, which is supposed to assure the accuracy of scientific information disseminated by the government, is another example of how leftish drug policy activists are seeing the value in legal tools traditionally associated with the right." (Hat tip to H&R, by the way.)

The pdf of ASA's federal complaint is here. The San Francisco Chronicle has coverage here. No article I've seen yet has a substantive response from any federal agency. I've asked the FDA for comment and will certainly add it if I get any response.

FDA Introduces "Labelman"

The Washington Post reports on a new tool the FDA has developed to help consumers understand information on food labels: Labelman.

Labelman lives over at the FDA's website, where he is accompanied by his mysterious sidekick "Interactive Training Module."

The appearance of Labelman raises several important questions, which are always relevant to the account of any superhero:

Dwelling: Does Labelman live in a cave? In a box of cereal? In a windowless cubicle of an adminstrative agency in Washington DC? This is a critical issue.

Nemesis: Who is Labelman's foe? The Abigail Alliance? Medical Marijuana dispensary operators? (I guess those are drug-related entities, not proper food-oriented foes.)

Superpower: What makes Labelman so powerful? Does his bright red coloring have anything to do with his superpower, or is it just supposed to indicate that he is a very cautious fellow? If you click on the interactive training module, you'll see that Labelman is able to run so quickly that he creates little puffs of smoke, so maybe speed is among Labelman's powers. His only other abilities appear to be the power of blinking and the power to wave a pointer around like a Third Grade teacher.   

At any rate, I'm looking to seeing the further exploits of Labelman. Perhaps he can even evolve in Recreational Use Drug Labelman, a hero who not only tells you the correct dose of medicinal drugs but can also help you stay safe if you use the drug recreationally.

(Hat tip: FDLI SmartBrief)

Advocates Push for FDA Tobacco Regulation

Piggybacking on today's post about the Cal Supreme Court decision on tobacco legislation, here's another quick tobacco item. Anti-smoking advocates, according to the Associated Press today, are

pushing to give the Food and Drug Administration authority over cigarettes and other tobacco products - just like the regulatory agency already has over countless other consumer products. A bipartisan group of lawmakers was to reintroduce legislation Thursday [2/15/07] to do so.

"We are quite excited about the possibility that we may very well get it done this time around," said Joel Spivak, a spokesman for the Campaign for Tobacco-Free Kids.

For decades, the FDA said it lacked authority to regulate tobacco so long as cigarette makers did not claim that smoking provided health benefits. In 1996, it reversed course and cited new evidence that the industry intended its products to feed the nicotine habits of the roughly 45 million Americans who smoke.

Reform at the FDA?

The New York Times reports:

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs. ...

Senator Christopher J. Dodd, Democrat of Connecticut, said in a written statement that far greater changes were needed at the agency. Mr. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans. The bills’ co-author, Senator Charles E. Grassley, Republican of Iowa, has called the agency far too “cozy” with drug makers.

In many cases, the date that the agency will begin the efforts announced yesterday is uncertain. For instance, Dr. Steven Galson, director of the agency’s drug center, said at the news conference that the pilot program to assess systematically a drug’s safety 18 months after its introduction would probably take about a year to put into place — with the assessment due 18 months after that.

“We’re just organizing that process to get started,” Dr. Galson said.

In a scathing assessment released in September, the Institute of Medicine concluded that the F.D.A. was rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations. The institute, the most important medical advisory organization in the country, suggested that the agency undergo 25 major changes, many of which would require Congressional authorization.

FDA Proposes Guideline on Access to Experimental Drugs

The AP reports today that the FDA has released proposed guidelines that would allow "greater numbers of seriously ill patients [to] get experimental medicines . . .  [and] allow drug companies to charge for the medicines."

Interestingly, however, the Abigail Alliance for Better Access to Developmental Drugs is characterizing the proposed guidelines (available here) as little more than a "smokescreen."

"They've taken an existing policy and put it into a regulation. We don't see any change there. There's nothing new that didn't already exist," said Abigail Alliance President Frank Burroughs in a conversation with Drug Law Blog. "What's really disheartening is that they've been working on this for three years and it falls short of the needed change that the Abigail Alliance and others have been pushing for." 

The Abigail Alliance is the plaintiff in the DC Circuit case on access to experimental drugs which will be reheard en banc.

Eschenbach Confirmed

From Bloomberg:

Dec. 7 (Bloomberg) -- The U.S. Senate confirmed Andrew von Eschenbach, President George W. Bush's nominee to head the U.S. Food and Drug Administration, after lawmakers blocked a vote for months because of complaints about the agency.

The 80 to 11 vote today followed a procedural decision to cut off debate, which circumvented efforts by Republican Senators Charles Grassley of Iowa and David Vitter of Louisiana to stall confirmation.

An earlier post about the challenges to Eschenbach's confirmation is here.

Ketek a Problem for Acting FDA Head

Senator Charles Grassley is blocking confirmation of acting FDA Chief Andrew Von Eschenbach because of Grassley's belief that Eschenbach is not being sufficiently forthcoming in requests for the FDA's information on the antibiotic Ketek, the Washington Post reports.

Back in June, federal regulators called for a halt to Ketek trials in children and issued a warning about the risk that Ketek could cause liver failure or death.

(Acting FDA Head Andrew Von Eschenbach)

The Post's article doesn't spell out what information, exactly, Grassley hasn't received from the FDA, but presumably he's trying to dig into what the FDA knew and when they knew it. Eschenbach is resisting, according to the article, because he contends that "the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch's enforcement and litigation functions."

Eschenbach's confirmation is turning out to be a powerful point of leverage for legislators who would like the FDA to be a more responsive, less partisan organization. Back in July, Senators Patty Murray and Hillary Clinton also held up the Eschenbach confirmation until the FDA agreed to grant over-the-counter status to Plan B. Lo and behold, the FDA granted OTC status in August, and Plan B manufacturer Barr Pharmaceuticals reportedly shipped the drug for OTC sale in November.

Hat tip to the FDLI SmartBrief.

Update: Eschenbach was confirmed by the Senate Dec. 7, 2006.

Back to the FDA's Preemption Preamble

This past summer one of my pet interests was the FDA's so-called "preemption preamble," which went into effect on June 30, 2006 and purports to forestall plaintiffs' suits for drug companies' failure to warn of drug dangers as long the companies have obtained FDA approval for their drug labels. Background discussion of the preamble is in this post from July as well as a longer post from June.

So what's up with the preemption preamble after about 6 months?

A two-part, subscription-only piece on the preamble ran on Martindale-Hubbell ran in September (a version of part one is available here), and the basic thrust of the articles seemed to be that the effect of the rule appears significant but perhaps not as dramatic as initially thought. In particular, the authors of the piece noted a Rhode Island Superior Court case, Cotu v. Tracy, Not Reported in A.2d, 2006 WL 1314261 (R.I. Super. 2006), in which the court rejected the notion that the state law failure-to-warn claim was pre-empted by FDA approval of an AstraZeneca label. The conclusion of the authors: "The Preemption Preamble appears to be landmark legislation on its face, but only the passage of time will reveal whether the new Rule is anything more than a puff piece."

Right on the same day the Martindale-Hubbell articles came out, a federal trial court in New Jersey issued an opinion in McNellis v. Pfizer, 2006 U.S. Dist. LEXIS 70844. In that case, the district court granted Pfizer's motion for an interlocutory appeal of its ruling on the pre-emption issue, which had cut against Pfizer but had been made before the FDA issued its final rule. The court added that it was

required to give less deference to an agency's interpretation of its own regulations  if the agency's interpretation of those regulations has not been consistent. Second, this Court finds that the majority of cases cited by Pfizer in support of its argument that this Court should grant deference to the FDA's interpretation of its regulations involve the agency's interpretation of an express preemption clause. As such, these arguments carry little weight in this Court's determination of the present regulations.  

Ultimately, however, the court passed the issue to the Third Circuit, certifying the following question: "Whether that the United States Food and Drug Administration's requirements for the form and content of the labeling for the prescription antidepressant Zoloft preempted New Jersey's failure-to-warn law, under the doctrine of conflict preemption, where the FDA's regulations at 21 C.F.R. 201.57(e) and 314.70(c)(6)(iii) permit a manufacturer to unilaterally enhance its warning when the manufacturer has reasonable evidence of an association of a serious hazard with a drug." I'm still of the opinion that the preemption preamble is going to be a very big deal. But we'll see.

En Banc Rehearing in Abigail Alliance v. Eschenbach

How Appealing notes that the DC Circuit's decision in Abigail Alliance v. Eschenbach will be reheard en banc. (Update: discussion of the 8/7/07 en banc decision is here.)
 

This is a big deal. As this blog wrote about in more detail in this post, the conclusion of Abigail Alliance was that individuals had a due process right to access potentially lifesaving drugs even before they have received FDA approval. That conclusion has interesting implications for a variety of issues, medical marijuana being just one (and not the most important one).

More background on this case is here (scroll through the posts to get the broader picture).

Scrutiny on Prescription Drug Giveaways

Reuters ran an article on 8/13 noting the controversy over drug companies giving away free samples of prescription drugs: "Drug makers say the coupons, rebates and similar promotions lower patient costs or provide the chance to try new medicines. Consumer groups, however, say they may draw people to risky drugs they may not need, without long-term savings."

It seems like you could make exactly the same complaint about drug advertising, which undoubtedly does encourage some people to use prescription drugs they don't need. And about advertising for plastic surgery. And teeth whitening. If our society banned advertising for things we don't actually *need* I think it's safe to say there would be very little advertising at all.

Also, it's odd to object to a giveaway on the grounds that it doesn't provide "long-term savings." Uh, yeah. It's a giveway. Most consumers are familiar with the concept and don't actually need to be rescued from their own interest in saving 20 bucks up front.

The Challenge to FDA Warning Letters on Advertising

Adweek reported on 8/8 that the Washington Legal Foundation, a conservative think tank, had "filed a petition with the Food and Drug Administration challenging the FDA's authority to send warning letters to drug companies whose advertising it finds misleading."

"The WLF believes the letters (which carry no legal weight but are routinely obeyed by drug marketers) contravene the First Amendment by making it impossible for drug marketers to advertise information that is not reviewed by the FDA, even though it may be truthful and accurate."

The website for the WLF is here, and the pdf of its press release on this issue is here.

I wonder what WLF makes of the FDA's preemption preamble. Something tells me they would be all in favor of the FDA's power in that realm, but I don't know that that's in fact the case.

Eschenbach Confirmation on Hold over Plan B

The New York Times noted yesterady that the confirmation of acting FDA head Andrew von Eschenbach is being held up by Senators Patty Murray and Hillary Clinton "until the FDA decide[s] whether to allow over-the-counter sales of Plan B pills." Reuters notes that the hearing on Eschenbach's confirmation will actually go ahead on August 1, but the vote to confirm will be delayed until the Plan B decision is made.

The last two FDA heads were closely involved in decisions to kill OTC status for Plan B, according to the LA Times.

Some FDA Scientists Claim Interference

From Reuters:

Fifteen percent of about 1,000 U.S. Food and Drug Administration scientists say they have been wrongly asked to withhold or alter information or their conclusions in agency documents, according to a survey released on Thursday by an advocacy group.

The liberal-leaning Union of Concerned Scientists said the results were further evidence of interference with science at federal agencies.

. . .

Seventeen percent said they had been asked by FDA officials "to provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials."

Forty percent said they feared retaliation if they voiced concerns about product safety in public.

Early Readings on the FDA's 'Preemption Preamble'

An FDA rule that went into effect June 30, 2006 -- known informally as the "preemption preamble" but also called a "regulatory time bomb" because it would pre-empt many claims of civil liability (see this background post) -- is starting to have some broad effects. In an oversimplified nutshell, the rule says that FDA approval of a drug label pre-empts any ability for a court to find that the drug company failed to provide adequate warnings about the drug's safety

The Philadelphia Inquirer reported on July 9 that, with the rule now in effect, "drug companies have papered courtrooms nationwide with motions to dismiss failure-to-warn claims." The paper notes, however, that most of motions have failed. The article also describes some more of the background of the Colacicco v. Apotex, the recent case in which a federal trial court in Philadelphia invoked the preemption preamble to reject claims of liability against the drug company that produces Paxil. (Again, see the background post for more info.)

A June 2006 legal update from the Mass Torts and Product Liability Group of Dechert LLP says Colacicco's interpretation of the preemption preamble, "if widely adopted, could result in far greater judicial acceptance of preemption in prescription drug product liability litigation than has previously been the case. . . . The ruling here, that the 2006 FDA Preemption Preamble represents an 'express statement of policy' worthy of Chevron [v. NRDC] deference, could well be a watershed that changes the fundamental landscape of prescription drug product liability litigation."

FDA Use of Warning Letters Falling

From the website in-Pharma Technologist.com:

A report on the US Food and Drug Administration’s (FDA) enforcement record by US Democratic lawmakers has highlighted a plunge in the number of warning letters the agency has sent to drug manufacturers since 2000, citing several examples where violations spotted in site inspections were not followed through.

The investigation found that officials at the FDA headquarters routinely rejected the recommendations of field officers, resulting in fewer enforcement actions.

The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50 per cent, from 1,154 in 2000 to 535 in 2005, a 15-year low according to the report.

Crucially, the decline in enforcement does not appear to be the result of increased compliance by manufacturers since the number of "483 forms," which record the number of violations observed by field inspectors, was higher most of the years between 2000 and 2005.

On the Bioidentical Hormone Debate

The Arizona Republic has an article today on a subject I've been meaning to write about: the controversy over bioidentical hormones. These are typically synthetic replacements for estrogen, produced from plants. Drug company Wyeth has argued that the FDA needs to regulate bioidentical hormones, and -- judging by the blizzard of comments that have been submitted to the FDA (you would need to click "next" on that docket page many, many times to see the thousands of letters and emails that have been submitted)-- many consumers and doctors have very strong feelings about the subject.

The FDA, according to the article, has postponed a decision on this issue because of its "complexity."

On Streamlined FDA Drug Approval.

Lawmakers should get behind the FDA's "Critical Path" initiative to streamline the approval process for new drugs, an op-ed in Thursday's Washington Times argues. The authors, Robert Goldberg of the Center for Medicine in the Public Interest, and Peter Pitts of the Center for Medicine in the Public Interest, argue that:

The real problem with drug development is not the loudly proclaimed issue of drug safety but the growing shortage of newer, more effective medicines that can treat or prevent the most costly and devastating diseases. The problem, as the FDA's Dr. Scott Gottlieb notes, "Is... the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end." This effort to adopt these approaches to drug, device and diagnostic development and increase the number of products hitting the market to improve health was dubbed the Critical Path Initiative by the FDA.

Hat tip to Kaiser's Daily Health Policy Report.

FDA Developing Simpler System For Reporting Drug Safety Problems

From the Associated Press:

The U.S. Food and Drug Administration said Wednesday it's developing a single electronic system for receiving information about potential drug safety problems.

While no firm timetable has been set, agency officials hope the new Web-based system is up and running within two years to help the agency more quickly analyze the nearly 500,000 adverse-event reports about drugs and medical devices it receives each year.

   

More on The FDA's 'Regulatory Time-Bomb'

A couple weeks ago this blog linked to a Forbes story about changes to prescription drug labeling practices that could (according to the story) make it more difficult for consumers to hold drug companies liable for unsafe drugs. The change would come as part of a rule on drug labeling, and the rule includes language stating that an FDA-approved label "preempts conflicting or contrary state law, regulations, or decisions of a court of law for purposes of product liability litigation."

That language certainly sounds quite broad. But the rule has nevertheless attracted very little attention. The Boston Globe did a piece on the change back in January, which is basically the extent of what's been written in the mainstream press. The Globe piece quotes Senator Kennedy as saying the rule change is "a typical abuse by the Bush administration take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry." Additionally, Rep. Hinchey -- the same legislator who is behind the Hinchey-Rohrabacher amendment that would end federal prosecution of medical marijuana users -- is quoted as saying the label rule "runs contrary to everything the FDA was set up for . . . [and] creates a situation where the drug companies are not going to be held responsible, in the way they should be, for the items that they put on the market."  On the other hand, a representative from a tort reform association is quoted as saying the change isn't that big of a deal. It's tough to know where the truth lies.

FDA Calls for Stop to Ketek Trials in Children

From the New York Times:

A Food and Drug Administration official called in May for a drug company to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other F.D.A. officials.   

The drug, Ketek, made by Sanofi-Aventis, is being tested as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States, according to postings on a government Web site. But Ketek, which is currently approved for use only in adults, has been reported to cause liver failure, blurred vision and loss of consciousness in adults.

This blog previously noted FDA concerns about Ketek on May 19, 2006.

FDA Drug Labeling Changes Said to Include 'Regulatory Time Bomb'

An article published today in the New England Journal of Medicine takes aim at a provision -- part of upcoming FDA changes to prescription drug labeling practices -- that will reportedly "make it almost impossible for patients to sue drug makers over adverse events," according to Forbes. 

"Along with the very modest alterations of drug labeling to be phased in over the next seven years, the changes the FDA [U.S. Food and Drug Administration] begin implementing next month include a regulatory time bomb that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products," the authors stated.

The labeling changes, which are set to go into effect June 30, include language stating that "any FDA-approved label, 'whether it be in the old or new format, preempts... decisions of a court of law for purposes of product-liability litigation.'"

According to the perspective piece, several members of the U.S. House of Representatives and Senate have already voiced their objection to the provision, and to the lack of debate preceding it.

Acting FDA Head to Step Down as National Cancer Institute director

From the AP:

Dr. Andrew von Eschenbach, the acting head of the Food and Drug Administration, announced Wednesday he would resign next month from his other job as director of the National Cancer Institute.

His resignation from the NCI will be effective June 10, said Christina Pearson, a spokeswoman for the Department of Health and Human Services.

Von Eschenbach's holding of both positions - one as director of a government institute that helps develop drugs, the other as head of the federal agency that regulates them - had raised questions of a potential conflict of interest.

Heroin Recall Desperately Needed; Turkey Sandwich Recalled Instead

With a lethal mix of heroin and fentanyl killing dozens of people across the Midwest in just a few weeks, now would be a great time to "recall" the deadly batch of heroin, if only it were possible to do so. We can't issue a recall, of course, because our government does not regulate recreational drugs. Which means that more people will die through accidental overdosing and others will do serious damage to their health.

Fortunately, however, our regulatory system is hot on the trail of other dangers to public. Just last week, in fact, a recall was issued through the FDA for a hazardous turkey sandwich. The "Smoked Turkey on Sourdough Triple Decker Sandwich," manufactured by Jumbo Foods, is suspected of having been contaminated with Listeria bacteria. Nobody has, as yet, been harmed by this dastardly sandwich, but it's good to know that our government is looking out for us. And that we're fighting the important battles!   

Vioxx Whistleblower Alleges FDA Smear

Bloomberg reports today:

A U.S. Food and Drug Administration whistleblower who claimed Merck & Co.'s Vioxx painkiller caused 140,000 heart attacks and strokes testified that co-workers at his agency tried to damage his reputation.         

``I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me,'' Dr. David Graham said in a May 9 videotaped testimony taken for Vioxx litigation. FDA officials worked ``hand in glove'' with Merck to tarnish him, Graham said according to a sealed transcript of his remarks obtained by Bloomberg News.