“Pharmaceuticals: FDA Approved Warning Labels and Pre-emption”
At the invitation of the George Mason University’s Law & Economics Center, I recently went to Washington D.C. to debate Ana Reyes of Williams & Connolly on the subject of preemption in drug injury lawsuits. The video is available here.
I stated many facts during the discussion, and below are my sources for them.
In discussing how the FDA works in practice, I said:
- Studies have shown only 10% of new drugs are superior to medicines already available.
- Researchers at Harvard and Boston University found more than a quarter of drugs ended up with a new black-box warning or were withdrawn from the market
- Last September, researchers at Harvard found use of “expedited” review programs was soaring, so that more than half of new drugs are approved on an “expedited” basis, and most aren’t first in class.
- 85% of approved cancer drugs fail to improve survival.
- Drug companies heavily push “supplemental indications,” with 295 approved between 2005 and 2014. Only 30% of approvals were supported by clinical trials using active comparators or studies related to patient health.
I quoted In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015) for the bolded portion below:
The line Wyeth and PLIVA thus draw between changes that can be independently made using the CBE regulation and changes that require prior FDA approval also makes some pragmatic sense. CBE changes rest on the existence of “newly acquired information.” 21 C.F.R. § 314.70(c)(6)(iii). A state law duty to initiate such a change is therefore not by its nature a second guess of an FDA judgment. Wyeth, 555 U.S. at 578-79, 129 S.Ct. 1187. To the extent that the underlying policy issue is one of who decides whether and how a drug can be marketed, the line so drawn lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops. The CBE regulation, too, covers virtually all situations in which new information indicates new or greater risks, or misleading claims of efficacy. By hinging preemption on the availability of that procedure in a particular case, Wyeth effectively reserves the launch of new drugs to the expertise of the FDA, but then preserves a wide scope for the states in requiring manufacturers to respond to information not considered by the FDA.
An audience member asked a question about the “cost” of drug lawsuits, and in my response I mentioned that society as a whole has already paid for the injuries caused in the form of medical bills, economic damages, and lost work from the plaintiffs. You can read more about this issue, and about how these lawsuits produce recoveries for the government and health insurers, in this post about subrogation.