FDA Funding
This article was originally published in SRA
Executive Summary
President Bush approves US agency funding for FY 2006
President Bush approves US agency funding for FY 2006
US President George Bush has signed into law the legislation allocating funding for the Food and Drug Administration (FDA) in the 2006 fiscal year. The FDA will receive $1.84 billion for salaries and expenses. Of this, $305 million will come from prescription drug uses fees and $11 million from animal drug user fees1,2.
President Bush gave his approval to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (HR 2744) on 10 November 2005. Of the total, among other things:
- $520 million is to be allocated to the Center for Drug Evaluation and Research;
- $178 million to the Center for Biologics Evaluation and Research;
- $99 million to the Center of Veterinary Medicine; and
- $41 million to the National Center for Toxicological Research.
The budget is greater than that allocated to the agency in FY 2005, following requests from the agency for more money to fund enhanced postmarketing surveillance of drugs and increased resources to enable it to respond to potential safety issues or terrorist threats3.
Conflict of Interest
The bill contains new conflict of interest disclosure requirements relating to the FDA's practice of using outside experts with links to industry on its advisory panels. The agency often waives conflict of interest prohibitions if the subject under discussion is of general interest. However critics say this practice needs to be tightened up in order to ensure that panel members always give objective opinions.
Under the bill, the FDA can proceed with a waiver if the Health and Human Services (HHS) secretary discloses on the FDA website the nature of the conflict of interest and the nature of the waiver no later than 15 days before an advisory meeting takes place. If a conflict of interest is discovered less than 15 days before the meeting, the FDA may proceed with the waiver as long as it makes a disclosure as soon as possible, and in any event no later than the date of the meeting. Also, the FDA commissioner must make quarterly reports to the HHS Inspector General and the House and Senate Appropriations Committees on the efforts they have made to identify qualified people with minimal or no conflicts for appointment to advisory committees. The FDA cannot appoint new people unless these reports are made.
Congressman Maurice Hinchey (Democrat - New York) protested that the bill was ‘a do-nothing amendment and a lost opportunity for real progress’4. An earlier House of Representatives version of the bill had included an amendment from Rep Hinchey that would have prevented the FDA from spending any money on waivers for advisory committees, effectively ending the practice of including scientists on advisory panels with ties to the drugs and devices in question. The House approved that version in June 2005, by 218 to 210. A less strict measure approved by the Senate in September 2005 served as the foundation for the language that was finally agreed upon between House and Senate negotiators, Rep Hinchey said.
‘What this final version essentially says to the FDA is if you want to continue using doctors and scientists with conflicts of interest go right ahead, just let us know about it. That's unacceptable,’ Rep Hinchey said.
References
1. Whitehouse press release, 10 November 2005, www.whitehouse.gov/news/releases/2005/11/20051110-14.html
2. H.R. 2744: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006, http://thomas.loc.gov
3. The Regulatory Affairs Journal - Pharma, 2005, 16(3), 223
4. Rep Maurice Hinchey press release, 28 October 2005, www.house.gov/apps/list/press/ny22_hinchey/morenews/102805fdaconflicts.html