Wyeth v Levine #2: Implications for drug manufacturers
Yesterday, I presented my overview of the US Supreme Court decision in Wyeth v Levine, to join the thousands of other overviews published online in the last couple of days. Many of those commenting are focusing on the implications of the decision for consumers and lawyers. You will find less commentary on the likely business policy and practice implications. That’s where I’d like to take the discussion today. I’ll begin with some choice snippets from other blogs and end with my own thoughts.
For its part, Wyeth expressed its disappointment on behalf of itself and its customers:
Patients are best served by a national standard for the labeling of prescription medications — set by the medical and scientific experts at the U.S. Food and Drug Administration (FDA). When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.
PhRMA joined Wyeth in its concerns regarding doctor and patient second-guessing of drug labels:
PhRMA is still reviewing the various opinions in the Wyeth v. Levine case. We continue to believe that the expert scientists and medical professionals at the Food and Drug Administration (FDA) are in the best position to evaluate voluminous information about a medicine’s benefits and risks and to determine which safety information to include in the drug label. Healthcare providers and patients rely on FDA-approved drug labeling every day in making critical decisions about whether a medicine is the best treatment for an individual. Unfortunately, patients could ultimately suffer if the Supreme Court’s decision forces healthcare providers and patients to second-guess FDA-approved labeling.
PhRMA’s biotechnology counterpart, BIO, is thus far silent on the case decision.
Over at Overlawyered, Tom Franks sees the decision as an abdication of the SCOTUS duty to protect interstate commerce from the states and disastrous for industry:
[T]he 6-3 decision is the worst anti-business decision since United States v. Von’s Grocery 384 U.S. 270 (1966). Justice Thomas’s confused concurring opinion is especially disappointing, as it declares an abdication of the Supreme Court’s appropriate structural role to prevent individual states from expropriating the gains from interstate commerce. Sell your pharmaceutical stocks now, because the Supreme Court just declared it open season on productive business.
Merrill Goozner ofGoozNews views the decision as conservative:
The duty to warn is one of the oldest precepts in the common law. It’s the height of conservatism to insist on that business obligation, and, from a consumer’s perspective, right.
At the Drug Injury Lawyer Blog, Derek Braslow, sees this as a clear victory for the consumer, one that well leave big pharma scrambling to defend itself from product liability:
The majority opinion in Levine marks a decisive victory for tens of thousands of consumer lawsuits that arise – or will arise – from prescription drug injuries. It is unlikely that Big Pharma will go down without a fight on this issue – indeed, defense attorneys are no doubt hard at work already in crafting arguments to distinguish or marginalize Levine in other cases – but to be sure, the Court’s holding in Levine tips the litigation scale decidedly back in favor of consumer plaintiffs.
Writing in The Atlantic, full-time writer and industrial chemist Derek Lowe believes Pharma would like a powerful FDA (and by inference believes Pharma will be disappointed that FDA is actually relatively weak):
So this decision might look like a whack at the drug industry, but it’s actually a case of a federal agency being told that its powers aren’t as broad as it occasionally seems to think. You wouldn’t necessarily guess it to see that way the justices lined up in this case, but the verdict looks like a real endorsement of federalism. And in the same way, you might not guess it, but the drug companies would probably like for the FDA to be that powerful, actually - that way, some of the responsibility could be offloaded, and there would be a single place to go for regulatory clarity. (Or a single place to go to exert influence, if you want to look at it that way). But that’s not going to happen.
Finally, Val Jones of the Science-based Medicine blog was the big winner in the best interview category, snaring Wyeth lead counsel Bert Rein. Rather than steal Dr. Jones’ thunder and potentially infringe her copyright, I’ll provide just a summary of Mr. Rein’s views of how this decision will impact Pharma:
Pharmaceutical companies will have to insist on clear records from the FDA regarding its labeling decisions, further taxing FDA resources. Labels will have to become more restrictive; rather than simply warn they will more often be forbidding of certain practices (like administration route), putting the liability onus squarely on the prescribing physician if she fails to heed the restriction. Also, drug labels will revert to their former selves–increasingly long lists of possible side effects and warnings that serve to shield manufacturers from liability rather than teach professionals what is important about prescribing. As a result, labels will be less often read. Finally, the fear of widespread state liability suits and prolonged FDA reviews will dampen enthusiasm for developing drugs with potentially risky indications (regardless of benefit).
Now for my take, I completely agree with Mr. Rein, which must be a first for me, since I cannot recall completely agreeing with a legal colleague on a policy issue when I was in the industry. But he really nailed it, and so did Val Jones with her questions.
Years of label-reform negotiations between industry and FDA, moderated by groups like CIOMS, has led to improvements in US drug labels. By the 1990’s US drug labels had become almost pure medicolegal documents, with key information buried within mounds of useless adverse event listings, all the better to shield companies from failure-to-warn liability. But by the beginning of this decade, reform had made progress and eventually resulted in a major labeling initiative by FDA revealed in January 2006. I worry that after Wyeth v Levine many of these reforms will be forsaken and labels will once again be primarily intended for the courtroom and not the doctor’s office.
On the innovation side, there seems little doubt that companies will be more wary of studying and seeking indications for drugs with potentially severe liability consequences than they already have become of late. In particular, this wariness will be deeply felt in niche indications (e.g. pediatrics, special populations, rare diseases) and routes of administration, where the liability risk can easily outweigh the commercial benefits of an indication.
On the prescribing side, doctors and other prescribers, facing sole liability for failure to heed outright restrictions on what might currently be considered prudent prescribing practices, will be pressured by their employers (via malpractice insurers) into refraining from such off-label uses. The result is a little less autonomy than before; a little less artist, a little more recipe-follower.
Practically speaking, manufacturers will be forced to be ever more diligent with postmarketing surveillance, tying passive reporting to active surveillance measures. Waiting for FDA to get its own safety surveillance and analysis house in order will no longer be a viable option. Companies will have to unilaterally make changes to labels much more frequently than ever before, as soon as feasible upon receipt of new information, under CBE rules already in existence. And such label changes will have to be promulgated to prescribers more quickly than ever before. Increasingly, FDA will play a lesser role in both the initial safety label and changes to it throughout the product lifecycle. The role of pharmacovigilance experts in industry will become more prominent, and more expertise will be needed. Likewise, regulatory publishing and medical information groups will have to beefed up to handle their increased workloads. Technologies supporting these activities will be in ghigher demand as well.
