Sunday, January 25, 2009


From Auto Emissions to Drug Safety Standards?

The New York Times reported this evening that President Obama "will direct federal regulators to move swiftly to grant California and 13 other states the right to set strict automobile emissions and fuel efficiency standards...The directive makes good on an Obama campaign pledge and marks a sharp reversal from Bush administration policy."

The Bush administration policy referred to will sound familiar to those of us involved in the debate over FDA preemption. The NYT article concludes:

"The Bush administration denied the waiver in late 2007, saying that allowing California and the 13 other states the right to set their own pollution rules would result in an unenforceable patchwork of environmental law. The automakers had advocated such a position, saying it would require them to produce two sets of vehicles, one to meet the strict California standards and another that could be sold in the remaining states."

Hear the echoes? A "chaos of conflicting standards," putting manufacturers in the impossible position of having to meet both state and federal guidelines, etc., etc.. Of course, the implication of this ruling is that the national guidelines are _minimal_ standards, which states can raise if they choose. That was traditionally FDA's own position until the last eight years.

The NYT article can be accessed at:


  1. Talk about up-to-the-minute news reporting, The New York Times posted this story just 16 minutes ago! Good catch on the implications this ruling has for preemption, Justice. President Obama hit the ground running. Wow...

  2. Here on PharmaLittle, we don't mess around....

    Thanks, Nancy!

  3. In E.P.A.’s Doctor No – an editorial published in The New York Times on December 24, 2008 – two seasoned administrators expressed their concerns about the E.P.A. to the right person...

    “Last week, two prominent moderate Republicans — William K. Reilly, who ran the E.P.A. under President George H.W. Bush, and William D. Ruckelshaus, who served as administrator under both Presidents Richard Nixon and Ronald Reagan —sent a little-noticed but eloquent letter to President-elect Barack Obama.

    The gist of the letter was that the E.P.A. could be an enormously positive force in the fight against climate change and oil dependency. All it needed was someone who believed in its mission and was prepared to use the laws already on the books. Granting California its waiver, carrying out the Supreme Court decision, regulating emissions from vehicles and power plants — all this and more, they wrote, could be accomplished with the statutory tools at hand.

    This exhortation from two veterans of the environmental wars was designed to encourage not only Mr. Obama, but also Lisa Jackson, the woman he has chosen to run the agency. It was also, however, an arrow aimed at the ideologues who have been running the agency for the last half-dozen years — and a lament for how little they have done with the weapons Congress gave them.”

  4. I read this article this morning and wondered the same thing - might it extend to regulation of drugs? But the issue for drugs is different. EPA has for many years delegated enforcement of its programs under the Clean Water Act, Clean Air Act, Superfund (CERCLA), and Waste Management (RCRA) to states. The states apply to EPA, detailing how they will implement their own programs. The state programs must, at a minimum, meet federal requirements and standards, but individual states can selectively set more stringent requirements and standards. The delegation is a matter of both law and regulation. The states set up extensive regulatory agencies staffed with scientists, engineers and other qualified professionals, their legislatures must pass laws to authorize and fund the agencies, and to authorize the regulations written and enforced by those agencies. All regulations at the state level, including more stringent standards than those required by the EPA, go through rulemaking in each state, just as they would at the federal level.

    This system of delegation to the states does not exist for regulation of drugs and devices. There is no program for delegation of authority from FDA to the states, and states do not have their own expert agencies to administer drug and device regulations at the state level.

    Pre-emption as it is being discussed for drugs and medical devices is about whether a state court (judge and/or jury) can over-ride federal regulatory decisions and protections for the drug or device manufacturer, which is very different from what is now happening with air quality standards in California and some other states.

    With air, California made a rule for itself through an extensive rulemaking process, which the Bush Administration's EPA tried to squash. The states challenged the EPA's decision, and now the Obama adminstration appears to be reversing the Bush administration's decision to stand in the way of the states setting their own, more stringent air and mileage standards.

    With drugs and devices, it is much more about what protections would be available to a drug company when it is sued for damages alleged to have been caused by its product. It boils down to - if the FDA has decided that a drug is safe and effective, and its known side effects and risks are listed in the label, and someone is harmed by the drug anyway (either in a way listed on the label or otherwise), what protections are afforded the drug company if it did everything the FDA required to gain approval of the drug, and acted in good faith both before and after that approval?

    Not taking a side here, just pointing out the differences. I work in the environmental field, (and know a great deal about the FDA as well - having become an active patient advocate seven years ago because of personal experiences with FDA's failings) and while having different programs in every state has been good (financially) for environmental consultants like me, it can be confusing and creates a lot of extra work that often doesn't add up to better protection of the environment. Different states do indeed have different standards and approaches to regulating the environment. they also have their own certifications for working in their state, and a variety of other things that complicate complying with regulations. It also allows states to taylor their environmental regulations to what is most important to the state. For example, a rural state with many mining operations has different priorities than an urban state where the bigger problems are related to dense population areas and heavy industry.

    For drugs and devices, medical care doesn't vary in that way. Someone with hypertension in New Jersey has the same problems as someone with hypertension in Florida. Now consider a snowbird who spends winters in Florida and summers in New Jersey? Should the "rules" governing the availability and administration of the drug she gets in New Jersey be different from those that govern it in Florida? What if, because of a hostile legal environment, the drug she gets in New Jersey isn't marketed at all in Florida, or doctors won't prescribe it for fear of getting sued, or malpractice insurance companies exclude coverage for docs who prescribe it in Florida?

    Think these things won't happen? Maybe they won't, but they certainly could, and hoping they won't is a pretty risky basis for proceeding. All of this would have to be figured out in advance if we are going to let state courts do whatever they want with tort suits filed in their jurisdiction regarding medical treatments.

    Application of state pre-emption of medical treatments would be far more complicated and fraught with problems and unintended consequences than is the delegation system for environmental laws. Maye it could be done, but it would not be easy, and it could well create a colossal mess.

    I have given this a great deal of thought, and it seems to me a better solution would be to just make fixing the FDA a high priority. Consider it to be the emergency it actually is. If they were doing their job better, we wouldn't even be talking about state pre-emption. And incidentally, fixing FDA won't be easy either. They have a very serious science problem in that what they do isn't very scientific at all, which is why it isn't working. But at least we know what we have to fix, and where we have to fix it.

    Steve Walker
    Co-Founder, Abigail Alliance

  5. Steve - First of all, I enormously appreciate your thoughtful and well-informed comment. It is a great contribution to our new site. Thanks so much.

    I know essentially nothing about EPA, but it entirely makes sense to me that EPA and FDA issues are different. I did know about the Clean Air Act, etc., and how that interplays with other issues you raise. So just a couple of points.

    - What stuck me about the original article was the consistency of language between the Bush admin's argument against Cal. and its support of preemption. This language specifically: "allowing California and the 13 other states the right to set their own pollution rules would result in an unenforceable patchwork of environmental law."

    Clearly, based on what you write, the "unenforceable patchwork" imagery - which we have heard so often in the context of FDA preemption - does not much wash (so to speak) in the context of EPA.

    - As you well know, no state has set up a "mini" FDA with its own standards, labeling, etc.. Rather, the FDA preemption argument hinges on the notion that state tort law is _equivalent_ to a state "mini" FDA. Some judges have accepted that notion. Others have rejected it.

    I would simply say: No state judge or jury has ever had the power to withdraw a drug, change a label, or do any of the other regulatory actions that are, and remain, the exclusive prerogative of FDA. On the other hand, there are instances - most notably the SSRI litigation - in which civil litigation has ended up unearthing information that contributed to FDA's making label changes. Thus the pre-Bush notion that, much of the time, the two systems are complementary, not conflicting.

    - Regarding the issue of "fixing FDA" and its relationship to preemption, here are a few reasons why I think even a utopian FDA (praise the Lord) could never obviate the need for a civil liability system as well:

    1. There is a good deal of potential delinquence that may be relevant in civil liability but _entirely_ outside the purview of FDA. This would include, for example, a company using threat or other intimidation against medical researchers (as we saw in Vioxx and Avandia, for example) or torqued journal articles (the famous CLASS article in JAMA is the best example; FDA has no power over med journal editorial policies).

    - It would take a Stalinist-sized FDA (which no one wants) to gather the information and do the enforcement/deterence to which civil liability contributes. Unless you had undercover agents in the relevant places, companies will _always_ know more about their products, and sooner, than FDA possibly could - again, even a utoptian FDA.

    Thus, what a company does with such information, and when they do it, will be only partially impacted by even the most ideal FDA.

    - That said, the tort system also needs major changes. Personally, I support significant reform in the arenas of punitive damages, class actions, lawyer fees, and elsewhere. I believe the level of integrity is about the same among trial lawyers as within pharma - mostly pretty good, but with enough "bad actors" that there is work to do.

  6. I think this is a great exchange on this subject, and I think we are in agreement on the limitations of the FDA and courts to impose a "perfect" system of drug regulation and patient protection. One point of detail. Delegation by EPA has resulted in a patchwork of regulations and standards from state to state. They are enforcable because rules are by definition enforcable - but the fundamental question isn't whether they are enforcable, it is whether the appropriate level of environmental protetion is being gained. What is considered protective of the environment varies broadly from state to state, and those standards are significantly influenced by each state's special interests and politics. These types of influences are unavoidable at any level of government (federal, state, local), and are both a strength and weakness. I think it idealistic that the same tings won't happen in state courts wielding pre-emption powers. We likely would end up with broadly different case law and legal precedents across the country, just as we have with standards and regulations in the environmental arena. So the question is, would our health care system be better or worse for it? It might depend entirely on where one lives.

    So again, a complicated issue with immense potential for consequences. Integrated approaches to these issues seem to work the best. Perhaps instead of fighting for narrow changes intended to address narrow failings of the system, we should consider this a debate about how to best deliver health care, put everything on the table, and see how we can best fit it all together so everyone gets what they need from a responsive system. Utopian? Perhaps. But if we don't try, we won't get any closer to that utopia.

  7. I don't believe that argument of conflcting standards is an irrelevant argument in the opposition to State mandates on setting thier own environmental agenda; automobiale manufaturers main advantage is economy of scale. This is not the same argument that proponents of preemption are advancing. They wll not change their basic pharmaceutical manufacturing process as the case for preemption is based primarily on the idea that the notification requirments and failure to warn provisions are the issue, It's a lot simpler, at least in my mind, to change labelling requirements then it is to force broad based manufacturing changes for mass produced products.
    Although I am in favor of preemption for the phramaceutical industry I am not so sure that I conflicting emissions standards based upon statewide increases to existing environmental laws is the proper answer. This smacks to me of Big Brother idealogy relegated to control of the States.
    A perfect anaology is that of insurance companies that because of differing state standards withdraw coverage for entire States.
    I am sure that increased regulation at the State Level will only be passed along to an already finacially overstrapped community and the net result will be less options and more costly alternatives for consumers of these states.


  8. Thanks to Steve and Jim.

    As you both know, the preemption debate hinges on the notion that state tort law is equivalent to state's setting up, in essence, mini FDAs, with different labeling requirements, etc..

    I know there are key legal cases that have made that connection, but it has never been convincing to me. The core question in most torts is, indeed, failure to warn. And the Watergate questions: What did they know? When did they know it? What did they do? No jury has ever had the power to change a label, withdraw a drug, etc.

    So none of this involves a state asking for powers that are already the province of the FDA - One could argue that the Levine case is closer to that since no fraud or negligence is being alleged; just that Wyeth "should have done more" than the FDA required it to do.

    If this were a simple torts case, as it began, I would rule for Wyeth based on what I know. But to use it for FDA preemption seems to me to invoke a "nuclear option" that should (ideally) have been resolved on the merits of the original suit.

    Thus, if I were the Supreme Court (!), I would remand the case to Vermont and suggest they rethink the verdict. And I would say that preemption is for Congress to decide, in an amendment to the FDCA one way or another.

    But to use this case in order to

  9. What is your opinion in a case like Prempro? Do you think Wyeth was completely unaware of the dangers that were revealed in the WHI study? This drug has been on the market for so many years. How could it be possible that Wyeth never did its own study? Over the years,I can only remember Wyeth coming out with information that was positive. The last one , was how good it was at preventing heart attacks,and stroke

  10. It's June 5th. I thought that last question by "Anonymous" was really very good. It's been months! No pharma types out there are willing to even try and defend Wyeth. All you can hear are crickets!

  11. It's been months since that last post by Anonymous.Any Pharma types out there willing to defend Wyeth? All I can hear are the crickets.

  12. Even an Ostrich knows when his head is in the sand.


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