Congressional Leaders, Bush Administration, Supporters Respond To FDA's Request For $275M To Ensure Safety Of Imported Medical Devices, Drugs, Food

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Medical Devices / Diagnostics
Article Date: 16 May 2008 - 6:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

A coalition that is pushing for a significant funding increase for FDA praised Commissioner Andrew von Eschenbach on Wednesday for saying the agency needs an additional $275 million in funding to ensure the safety of imported food, prescription drugs and medical devices, CQ HealthBeat reports (CQ HealthBeat, 5/14). Von Eschenbach in a May 5 letter to Congress requested the additional funding. The letter was in response to a May 1 letter from Sen. Arlen Specter (R-Pa.) -- a member of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies -- that requested information on the amount of additional funding FDA would need "to protect the public's health." In his letter, von Eschenbach wrote that he was offering the spending plan "without regard to the competing priorities that the agency, the president and their advisers must consider as budget submissions to the Congress are developed" (Kaiser Daily Health Policy Report, 5/14).

Wayne Pines, president of the Alliance for a Stronger FDA, said, "Dr. von Eschenbach has broken with a long and unfortunate tradition of FDA leaders being silent publicly about the real needs of the FDA," adding, "Now it's up to Congress to fund the FDA with the resources it needs to retain its international leadership" (CQ HealthBeat, 5/14).

Subcommittee Chair Herb Kohl (D-Wis.) on Wednesday said, "Given the inadequacy of the president's budget for FDA, Congress must provide this immediate boost in funding for the agency so it may effectively fulfill the critical mission of protecting food and drug safety." Kohl last week proposed including $275 million for FDA as part of an emergency supplemental spending bill for the Iraq war. The Senate Appropriations Committee is expected to approve the bill on Thursday, according to the Wall Street Journal (Favole, Wall Street Journal, 5/15).

Bush Administration Response
President Bush has requested $1.77 billion for FDA in fiscal year 2009, an increase of $51 million from FY 2008, and $628 million in industry user fees. Corrine Hirsch, press secretary for the White House Office of Management and Budget, said that the "president's budget remains the official administration request" and "will allow FDA to meet its mission." She said, "This year FDA received a 6% increase in the president's budget relative to the enacted level of last year at a time when domestic discretionary spending overall was held to 1% growth in the budget" (CQ HealthBeat, 5/14).

Additional Legislation
In related news, House Democrats and industry officials on Wednesday held the third session in a series of planned hearings to discuss additional authority and funding for FDA and increasing oversight of imported drug products, cosmetics and medical devices, CQ HealthBeat reports. The hearing sought to encourage input for drug safety draft legislation, proposed by House Energy and Commerce Committee Chair John Dingell (D-Mich.). The bill would create a registry of all companies that manufacture drugs, food and medical devices for use by U.S. residents, and it would create a force of inspectors to monitor overseas productions of such products.

Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) said that while Congress in 2007 reauthorized a medical device user fee program, further efforts are required to ensure the safety of the devices. Pallone said, "The FDA is simply incapable of meeting the requirements of that legislation to inspect domestic and foreign device manufacturing establishments."

According to CQ HealthBeat, Democratic members of the panel also raised concerns about inadequate monitoring of the cosmetic industry by FDA and said the agency is too reliant on voluntary reporting (Carey, CQ HealthBeat, 5/14).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.