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
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:
- 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
- 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.
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!
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:
- Not to rush serious legislation. That you want a public hearing for the
complicated issues surrounding FDA "reform."
- 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.
- Reauthorize PDUFA without any controversial "reform" proposals. People
living with HIV/AIDS need the faster access to lifesaving drugs PDUFA helps
Let us know what kind of response you get.
New Mexico/Jeff Bingaman/202-224-5521/202-224-2852
Rhode Island/Jack Reed/202-224-4642/202-224-4680
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