House Subcommittee Chair Seeks Delay Of FDA Foundation Launch

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 08 Nov 2007 - 10:00 PDT

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House Appropriations Subcommittee on Agriculture Chair Rosa DeLauro (D-Conn.) on Thursday in a letter asked FDA officials to delay the launch of the Reagan-Udall Foundation because of concerns about the relationship between the foundation and industries regulated by the agency, CongressDaily reports (Edney, CongressDaily, 11/5).

The foundation, established under a legislation signed into law on Sept. 27, seeks to improve the development of medications and medical devices. On Oct. 3, FDA filed a public notice to seek applications for foundation board members, who must include four industry representatives, three academics, two consumer advocates, one health care provider and four "at-large" members. Some critics have raised concerns because private donations from food, pharmaceutical and medical device companies in large part will fund the foundation (Kaiser Daily Health Policy Report, 10/15).

In the letter, DeLauro raised concerns that the foundation might recommend reduced standards for the safety and effectiveness of products reviewed by FDA without safeguards against the influence of the industries. She wrote, "An independent, effective public-private partnership should be helpful in identifying areas of concern and strategies to benefit patients, consumers and corporations. Unless carefully structured and implemented, the Reagan-Udall Foundation could focus too much on an expedited approval process that results in the sale of blockbuster drugs and devices that are unsafe and ineffective" (CongressDaily, 11/5).

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