Below are some notes regarding the presentation by the FDA’s Gerald Masoudi today at the ACI Drug and Device Conference. Every effort was made to capture his comments accurately, but please excuse any errors created by capturing these comments on a BlackBerry:


FDCA gives FDA role of determining safety and efficacy and warnings, considering factors including patient profile and public health considerations.

Labeling is key method by which FDA communicates risks and benefits. FDA decides for populations, not individuals, and requiring safety and efficacy for every individual would lead to the absence of treatments.

Even with proper risk benefit judgment and prescribing, injuries can occur.

Products should neither under- nor over-warn.

State tort lawsuits decrease patient access, limit treatment options and interfere with the agency’s judgments.

Preemption does not reach manufacturers’ failure to comply with federal requirements (such as contamination with toxic substance) since there would be no interference with the FDA’s judgment.

FDA will make mistakes, but allowing juries to make failure-to-warn determinations would not be superior to the current system and the current role of FDA.

In Wyeth v. Levine, the court may issue a narrow decision–we all will have to wait to see. But it is not new for FDA to support preemption. It has been the agency position in litigation, testimony, and preambles to rules. FDA reiterated its support recently in a pregnancy labeling proposed rule and CBE rule from earlier this year. This readoption should answer any question that the agency’s Final Rule on drug labeling, which also had preemption in a preamble, was improperly promulgated.


The Wyeth decision, of course.

But what about preemption in off-label cases? Sponsor can’t change label without FDA approval. What if physician prescribes off-label because of some prompting by manufacturer? If plaintiff’s tort suit says there should have been warnings for the off-label use, the defense is less strong as there is little federal interest in off-label promotion. This area of law needs more development to answer the question.  


There may be a legislative response, but again we will have to wait to see.

As to any exception for the manufacturer’s alleged failure to disclose to the FDA, when the FDA has not found fraud, the preemption defense is stronger. It would create interference with the agency’s decisions to allow courts to decide if the FDA was defrauded. Moreover, the FDA should decide what the punishment for it should be for manufacturer nondisclosure.


FDA warning letters are a statement by the agency that someone is in violation of the law and legal action may be taken. For the past few years, the chief counsel’s office has reviewed all of them.

Because they involve a legal determination, and are very serious for the recipients, they are appropriate for attorney review.

Even if counsel review leads to fewer letters, which is not clear, stronger letters with a stronger impact is a beneficial result of counsel review. It adds heft to both the letter and to the agency’s decision to take an enforcement action, since recipients and the courts know the agency’s counsel has decided that legal action will be appropriate (if the conduct is not remedied) when warning letter issued.