"FDA Reform" Proposals In Congress Pose Great Danger To People Living With HIV
Calls Needed Immediately To Members Of Congress
The two "FDA Reform" bills moving through Congress, S.1477 and the more extreme H.R. 3199, will jeopardize public health by dramatically increasing the odds that unsafe and/or ineffective drugs will reach the American consumer. For people with serious and life-threatening illnesses such as HIV disease, these proposals will likely result in unnecessary delays in the approval process and substantially less data on whether new drugs will be effective in treating the conditions for which they will be marketed.
In their present form, these bills are being described by proponents as tools for getting drugs to patients more quickly. These "reforms" are actually gifts to drug and medical device manufacturers that will make it cheaper and easier for them to sell their products without ever having to prove that their products are safe or effective for human use. Nothing in these bills will improve the effectiveness of the FDA.
The Most Dangerous Elements of These Congressional Proposals Include:
- Imposing rigid new timelines on the FDA while at the same time the congressional leadership is proposing drastic cuts in the agency's budget. These bills will force the agency to do an astounding number of new duties with severely strained resources resulting in more outright refusals of new drug applications and marketing of more unsafe and/or ineffective drugs.
- Making it more difficult for the FDA to prioritize approvals for drugs for serious diseases. Since all FDA action on drugs will have to be made in essentially the same amount of time, these bills will result in longer, not shorter, review times for drugs to treat serious or life-threatening conditions. For example, a new treatment for baldness would have only a slightly longer mandated approval time than a breakthrough treatment for cancer or AIDS.
- Shredding protections for patients who participate in clinical trials by arbitrarily shortening the time FDA has to review critical safety data before allowing clinical trials in humans to move forward; limiting the FDA's ability to stop a trial even when investigators are unqualified or sponsors have submitted misleading information to investigators; and by allowing sponsor companies to keep information from reaching the FDA about deaths or withdrawals of participants in clinical trials.
- Dangerously lowering the FDA's "gold standard" for safety and efficacy by making the FDA prove a drug or medical device is unsafe and ineffective rather than having the sponsor prove it is safe and effective. Lowering the standard for approval from "substantial evidence of safety and efficacy" to a "reasonable assurance of safety and efficacy," and forcing the FDA to approve drugs for serious and life-threatening diseases that are less effective than those already on the market.
- Endangering the safety of the blood supply by allowing third parties to inspect blood suppliers, limiting the FDA's ability to recall tainted blood and blood components, preventing the FDA from recalling dangerous blood products until the public has already been harmed, and denying FDA's ability to regulate the use and sale of human tissues.
- Permitting third parties Ä including researchers hired by pharmaceutical and blood product manufacturers Ä to make FDA approval a mere rubber stamp regardless of the reviewers lack of experience or inherent conflict of interest.
Status of FDA Reform Bills: The Senate bill (S. 1477) passed the Labor and Human Resources Committee in late March. Three key Democrats -- Dodd (CT), Harkin (IA), and Mikulski (MD) supported the Republican proposal and voted for the bill. The bill is not yet scheduled for a full Senate vote, but could come to the floor of the Senate at any time. The House bill (HR 3199) will probably be voted on in the House Commerce committee sometime in early June. Our goal is to convince Senate and House members that passing this ill-conceived legislation to dismantle the FDA is not only politically risky in this election year, but endangers the health of all Americans.
- Press Statements from Your Agency: We desperately need press statements in opposition to the FDA reform bills. Use the points outlined in this alert to draft your agency press statement in opposition to radical FDA reform. The statements should be printed on your organizational letterhead and faxed to AIDS Action at 202-986-1345. We need these press statements by Friday, May 31, 1996.
- Call-In To Senators and House Members: We need a huge call in to senators and representatives on Tuesday, June 4th and Wednesday, June 5th. The message: Oppose the House and Senate FDA reform bills as irresponsible deregulation of the FDA! Because these bills are a prescription for disaster, every individual and organization needs to pull out all the stops and generate as many calls as possible!
All members of the House can be reached through the Capitol Switchboard at 202-225-3121, and all Senators can be reached at 202-224-3121. E-mail addresses for your Representatives and Senators can be found posted in HandsNet at Resources/Congressional Contacts.
Reminder: The House VA/HUD Subcommittee will mark-up its bill on Thursday, May 30. Calls are needed to subcommittee members urging increases in HOPWA funding for FY 97. Please refer to AIDS Action Alert dated May 23, 1996.
For more information, contact:
AIDS Action Council
1875 Connecticut Avenue NW #700
Washington DC 20009