Thursday, October 30, 2008

Cong. Waxman Positions for the Levine Argument

It's to be expected, especially since we sort of did it ourselves, but folks with irons in the fire are positioning themselves in advance of next Monday's oral argument in Wyeth v. Levine.


Getting the most play is a "staff report," written by the majority (Democratic) staff of House Oversight Committee for Chairman Henry Waxman - not for the committee as a whole.


Predictably, it's a political document, not approved by the full committee, and just as predictably it's an anti-preemption screed, produced at public expense.


The staff report collects the internal dissents of 2 FDA staffers (Drs. Jenkins and Axelrad), see pp. 2, 4-14, from the agency's conclusion in 2006 that the realities of modern tort litigation - the advent of claims, such as fraud on the FDA, SSRI/suicidality claims, failure to contraindicate, etc., that sought to overturn or ignore in-force FDA decisions - more strongly implicated preemption than in the past.


Two objectors aren't very many in an organization as big as the FDA. Indeed, they are outnumbered, even in the report, by the FDA's preemption supporters (at least Troy, Ray, Bradshaw, Masoudi - probably others, but we're being conservative). The small sample size suggests that Waxman's staff may have chosen to focus only on a couple of career FDA officials who opposed preemption, without mentioning those career officials who supported it. We can't say for sure, since we don't have unlimited taxpayer funding, nor do we wield congressional subpoena power.


But we do know this: In litigation, we often see an advocate choose documents selectively, and the truth only comes out when the entire documentary record is disclosed. Indeed, we hardly see anything else. And we see it here. The report quotes (on p.5) a 6/18/03 email from Dr. Jenkins, to Dr. Axelrad and others, but the appendix, also on page 5, reveals a significant omission:
I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process.
We aren't going over them all - we're not on the taxpayer's dime, after all. But this one example is enough to convince us that we're looking at advocacy, not oversight, in this report.


We also know this: The basic thrust of the report - that the FDA's preemption position is a purely political gambit by the Bush administration, see p.1 - isn't true. The FDA has been going to court advocating preemption at least as far back as 1991, when product liability discovery threatened its voluntary reporting system. The current string of pro-preemption position FDA amicus briefs began in 1999, during the Clinton administration, in response to the burgeoning of fraud on the FDA litigation.


This is all a matter of public record. We've compiled the complete history of FDA pro-preemption amicus briefs, with links to every brief, here. And we didn't spend a dime of taxpayer funds, issue a single subpoena, or write a single threatening letter to the FDA.


Not only that, the FDA has a long history, going back at least to the 1970s, of supporting preemption in various contexts. It's all in the Federal Register - and none of it's in this staff report. But have no fear, we've laid it all out, here. For example, here's a tasty nugget from 1995:
Under the Supremacy Clause of the Constitution, State laws that interfere with or are contrary to Federal law are invalid. Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. Preemption may be found where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress left no room for supplementary state regulation, or where the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.

Federal preemption may also be found where Federal law conflicts with State law. Such conflict may be demonstrated either when compliance with both federal and state law is a physical impossibility, or when State law stands as an obstacle to the
accomplishment and execution of the full purpose and objectives of Congress. State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals.

Additionally, a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law. Federal regulations have no less preemptive effect than federal statutes.

When an agency’s intent to preempt is clearly and unambiguously stated, the Court’s inquiry will be whether the preemptive action is within the scope of that agency’s delegated authority. If the agency’s choice to preempt represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by statute the regulation will stand unless it appears from statute or its legislative history that the accommodation is not one that Congress would have sanctioned. . . .

Conflicts between State and local . . . laws and Federal law . . . justify FDA’s preemption of these laws. Although Congress did not expressly preempt State law in this area, the agency’s action is appropriate because State and local laws significantly interfere with the methods by which the Federal law is designed to achieve its goals.

60 Fed. Reg. 16962, 16965-66 (FDA Apr. 3, 1995) (lots of citations and internal quotation marks omitted). There's lots more where that came from. Again, it's all free of charge, no taxpayer $$$ being used.


The report also attacks the 2008 revisions to the FDA's "changes being effected" regulation. See p.3. But the original administrative history of that regulation, dating back to 1982, make it perfectly clear that the CBE regulation was only intended to apply to drug risks that were newly discovered or newly discovered to be much worse. That's precisely what the 2008 change made explicit in the regulation itself, since courts were distorting it, and ignoring regulatory intent. We've blogged about that, too. Moreover, the four examples in the report relating to the CBE exception, see pp. 12, 15-16, all involved newly discovered risk information - precisely what the regulation was always intended to apply to, and still does after the 2008 amendment.


With respect to the 2008 amendments to CBE regulation, there's just no "there there" in the report. The two more recent situations mentioned on pp. 15-16 raise issues involving the "Highlights" section of post-2006 drug labeling - and do not implicate the CBE regulation.


So we hope the report's intended audience (the Supreme Court and the press - certainly not us) will view the report as the political/advocacy document it is, and treat it with the proper (high) degree of skepticism. The report's omissions are at least as significant as what it includes.

2 comments:

hg said...

Lots to respond to, but let's just focus on one point.

Of course, there were earlier, individual instances in which FDA invoked preemption. But that has nothing to do with the developments that began in 2002. At that time, FDA and the Bush administration fully acknowledged that its position on preemption was "180 degree" (their phrase) change from earlier positions. Some of the key cases, as you know well, hinge on the notion that agencies like FDA can make such changes if they choose to.

Yet you also argue there really was no change.

I don't thin you can have it both ways.

Beck/Herrmann said...

To HG:

You're confusing the FDA's position with respect to express preemption under the Medical Device Amendments, which was clearly a reversal of position, with the FDA's position on implied preemption outside of the MDA context.

There's been little change in the FDA's basic position on implied preemption since at least 1999, and we believe that the currently greater emphasis on implied preemption comes as a result of the proliferation of tort claims, such as SSRI suicide, fraud on the FDA, and the like, that seek to overturn or ignore affirmative FDA decisions. Where those kind of claims don't exist, such as in the Perry case, the FDA hasn't supported preemption.

If you look at the types of claims that brought the FDA into court, you'll see why ee believe that the plaintiffs' side brought preemption on itself by pursuing claims that invaded the FDA's sphere. Fraud on the FDA. The Paxil case where the plaintiffs wanted to enjoin FDA-approved advertisements. The SSRI cases where the FDA looked at the suicide question time and time again. None of them were routine "you didn't warn me of a new risk in a timely fashion" cases that were the plaintiffs' side bread and butter in the 1990s and before.