House Questions FDA's Priorities

ePT--the Electronic Newsletter of Pharmaceutical Technology

In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency's priorities, specifically poking at FDA's political appointees and whether they are promoting industry at the expense of the public's health.

Washington, DC (Sept. 25)-In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency’s priorities, specifically poking at FDA’s political appointees and whether they are promoting industry at the expense of the public’s health.

Waxman chairs the US House of Representatives’ Committee on Oversight and Government Reform. According to his letter, the committee received copies of internal agency emails that “raise questions about who is setting agency’s priorities and why.”

One particular set of emails between Sheldon Bradshaw, Scott Danzis, and Tevi Troy that are mentioned in Waxman’s letter seem to demonstrate special attention paid to FDA guidances that are of interest to the drug and device industries. Internal agency emails also seem to show that certain projects are being rushed through, says Waxman, with “unprecedented speed.” For example, the proposed rule to amend regulations that permit companies to update drug and device labels with new safety information was proposed on Jan. 16, 2008 and finalized on Aug. 15, 2008. Also, the draft guidance on distribution of journal articles was issued Feb. 16, 2008.

Waxman suggested that the agency’s priorities should be different, as pointed out by the FDA Science Board in November 2007. The Board noted the current import system, development of new therapies, and information infrastructure as sources of risk and therefore, in need of FDA attention. These items were not in the emailed list of priorities between Bradshaw, Danzis, and Troy.

The Oversight committee has asked FDA to respond to Waxman’s letter by Oct. 6, 2008.