Senate Again to Consider FDA "Reform": PDUFA Reauthorization Threatened -- Calls Needed to Labor Committee Senators

Food and Drug Administration (FDA) reform is again on the congressional agenda this year. After patients and consumer groups successfully fought devastating reform proposals last year, Congress once again is planning on making dramatic changes to the Food, Drug, and Cosmetic Act (FDCA), one of the nation's most important and fundamental pieces of consumer protection legislation. The FDCA created the FDA to protect all Americans by making sure the medicines we take are both safe and effective

On Wednesday, June 11, 1997, the Senate Labor and Human Resources Committee, chaired by Senator James Jeffords (R-VT), will begin consideration of a bill that will propose changes to the FDA and reauthorize the Prescription Drug User Fee Act (PDUFA), a program that helps speed the review and approval of new drugs. AIDS Action and patient advocates are supportive of reathorizing PDUFA quickly. However, we are extremely concerned that the PDUFA reauthorization is tied to changes to the FDA -- changes that could be harmful to persons living with HIV and AIDS [see below].

Unfortunately, patients and groups including AIDS Action were knowingly and actively excluded from the negotiations on the bill that took place between Labor Committee staff, industry, and the FDA. Since changes to FDA will ultimately affect patients and consumers, more public discussion is needed so patients, consumers, and groups like AIDS Action can have a chance to publicly comment on these vital and dramatic changes to the drug and device approval process.

FDA Reform Provisions

We are extremely concerned about a number of proposals contained in the current version of the bill that would dramatically lower the standards and processes used to approve new drugs and devices. These proposals threaten to weaken the mission of the FDA to protect the American public by making sure drugs and devices are safe and effective. Two of our gravest concerns are:

1. Lowering the standards for drug safety and effectiveness by permitting fewer or no well-controlled studies of drug safety and effectiveness AND by permitting FDA approved drugs to be used for new and unapproved uses without studies to determine their appropriateness; and

2. Eliminating or weakening most regulatory protections against unsafe medical devices by allowing manufacturers to select and pay for-profit reviewers to certify that their products are safe and effective and by repealing mandatory post-approval observation for all devices which is needed to ensure that devices do not cause serious injury or death to patients.

These provisions lower the safety and efficacy standards for our drugs and could endanger the health of people living with HIV/AIDS and other people who rely on prescription drugs and devices to maintain health. People living with HIV/AIDS rely on safe and effective drugs to keep them alive and healthy. These "reform" proposals threaten the safety and effectiveness of the medicines PWA's take. Additionally, by tying these reforms to reauthorizing PDUFA, the program that helps get drugs to market quickly is also threatened.

PDUFA

The Prescription Drug User Fee Act (PDUFA) was created five years ago to make significant improvements in the FDA's review and approval of new drug applications and to help get promising new drugs to patients faster. PDUFA charges drug manufacturers fees whenever they apply for FDA approval of a drug they are developing. These fees have allowed FDA to cut in half the time it takes for them to review new drug applications dramatically cutting the time it takes for a new drug to get to market for sale. Congress only authorized PDUFA for five years. To guarantee the continuing success of the program and to make sure PDUFA's lifesaving benefits are not threatened, Congress must reauthorize the program by September 30, 1997. However, by tying controversial FDA "reform" legislation to PDUFA reauthorization, Senate Republicans are threatening the life-saving benefits PDUFA has provided to people living with HIV/AIDS. If PDUFA ends, people with HIV/AIDS will not get new drugs as quickly because the drug approval process will slow down.

Your Senator's voice is important in this debate and they need to hear from you!

AIDS ACTION:

Contact your Senator [from the list below] on the Labor and Human Resources Committee and tell them to stop messing with the public's health and safety.

Tell your Senator:

1. Not to rush serious legislation. That you want a public hearing for the complicated issues surrounding FDA "reform."

2. Stop hurting people living with HIV and AIDS by weakening the FDA's ability to protect them from unsafe and ineffective medicines. Don't lower the U.S. gold standard for drug, device, and food safety.

3. Reauthorize PDUFA without any controversial "reform" proposals. People living with HIV/AIDS need the faster access to lifesaving drugs PDUFA helps provide.

Let us know what kind of response you get.

State/Senator/Phone/Fax:

Connecticut/Christopher Dodd/202-224-2823/202-224-7475

Iowa/Tom Harkin/202-224-3254/202-228-2923

Maine/Susan Collins/202-224-2523/202-224-2693

Maryland/Barbara Mikulski/202-224-4654/202-224-8858

Minnesota/Paul Wellstone/202-224-5641/202-224-8438

New Mexico/Jeff Bingaman/202-224-5521/202-224-2852

Ohio/Mike DeWine/202-224-2315/202-224-6519

Rhode Island/Jack Reed/202-224-4642/202-224-4680

Tennessee/Bill Frist/202-224-3344/202-228-1264

Vermont/Jim Jeffords/202-224-5141/202-228-1967

Virginia/John Warner/202-224-2023/202-224-6295

Washington/Patty Murray/202-224-2621/202-224-0238

For more information, please contact Chad Lord at 202-986-1300, ext. 3062.

AIDS Action Council
1875 Connecticut Avenue NW #700
Washington DC 20009
202-986-1300, extension 3053
202-986-1345 (fax)
202-332-9614 (tty)
E-Mail: aidsaction@aidsaction.org