FDA responds to Big Pharma’s Citizen Petition
Big Pharma asked the U.S. Food and Drug Administration to overhaul a newly finalized regulation that gives the agency wide latitude to police off-label promotion. Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drug maker coalition known as the Medical Information Working Group, filed the petition on February 8, 2018. The petition claims the rule contains unconstitutional policy changes. These organizations represent many drug makers, and their petition challenges the FDA’s new rule for evaluating “intended use” of prescription drugs and medical devices. An important concept, intended use helps the FDA assess whether companies are intentionally marketing products for unapproved uses.
The Citizen Petition
The FDA’s final rule includes new language explaining that the agency would ponder “the totality of the evidence” when judging its’ intended use. The three groups filed a citizen’s petition because they believe that the FDA violated the Administrative Procedure Act. This act states that stakeholders should be given fair notice of the revision and given the opportunity to comment.
The petition claims consequences resulting from the revised definitions, subjective totality of the evidence standard will result in:
- an increase in the False Claims Act litigation and
- a chilling of free speech about legitimate scientific date related to off-label uses of medical products.
The FDA postponed the effective date of the rule until March 21, 2017. Doctors maintain the authority to prescribe drugs if they believe it will benefit the patient in any way, but manufacturers cannot promote their products for off-label uses without facing enforcement action by the agency.
Proponents for the off-label promotion argue that allowing pharmaceutical companies to communicate true, non-misleading information to physicians opens the flow of information by ensuring that doctors are informed of all their patient’s options by also making off-label treatments available. Opponents see the off-labeling promotion as “inappropriately exposing patients to risk.”
The FDA held a public meeting to hear its stakeholder’s positions on manufacturer communications of unapproved uses for medical products. They also released a memorandum that paints them as dead set against changing its off-level policies. The FDA currently lacks an appointed commissioner. FDA policies will almost certainly change based on decisions that need to be made by the Executive and Legislative branches.