Committee Presses FDA for Documents On Trial Lawyers’ Role in Proposed Changes to Generic Drug Labeling

April 22, 2014

WASHINGTON, DC – House Energy and Commerce Committee members today sent a letter to Food and Drug Administration Commissioner Margaret Hamburg, M.D. expressing their concerns regarding the administration’s proposed changes to generic drug labeling. The committee leaders are also concerned with the motivation behind the proposed rule, and who was – and was not – involved in drafting this proposal. The letter follows up on a January 22, 2014, letter to FDA and April 1, 2014, hearing with the FDA regarding the proposed changes.

In the letter to Commissioner Hamburg, the committee members write, “As discussed in a bicameral letter we sent to you on January 22, 2014, the committee has significant questions about FDA’s primary motivation for initiating this rulemaking, the agency’s legal basis for proceeding in this manner, and the consequences such an approach would have on providers and patients. Further, the committee is interested in better understanding the involvement of certain individuals and outside organizations in the development and review of the proposal… It is critical that the public have confidence in the impartiality of FDA’s regulatory actions.”

The members continued, “(T)he only outside interest group agency officials apparently met with while developing the proposal was the American Association for Justice (AAJ), otherwise known as the Association of Trial Lawyers of America.  On April 1, 2014, in testimony before the Energy and Commerce Subcommittee on Health, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Health Subcommittee that while FDA did not in fact meet with the generic drug industry, branded drug industry, physicians, or pharmacists, it was her understanding that ‘part of the agency did meet with the trial lawyers.’”

The proposed changes to generic drug labeling undermine decades of successful practice. FDA has said that it proposed these changes to get updated safety information to patients and providers more quickly, but it failed to consult either of those parties in drafting these changes. Further, as the letter states, “it is not at all clear why plaintiffs lawyers would have any role in the development and review of the proposed rule.”

Committee members are seeking all documents and communications between FDA and the sole organization agency officials met with as the rule was being developed, the AAJ, regarding their meeting discussing the proposed rule.

Read the complete letter online here.