Legislation has been introduced in the Senate (S. 830) that will drastically change the Food, Drug, and Cosmetic Act (FDC Act), one of America's premiere patient and consumer protection laws. The FDC Act authorizes the Food and Drug Administration to regulate drugs and medical devices ensuring that the products consumers and patients use are safe and effective and protecting consumers from deceptive or false claims.
The drug and medical device industries are claiming that the "reforms" in S. 830 will improve FDA approval processes thereby speeding new drugs and medical devices to patients. In reality, these "reform" provisions are gifts to drug and medical device manufacturers making it cheaper and easier for them to sell their products without rigorous testing to prove that they are safe and effective. There is nothing in this bill that improves the FDA's effectiveness. There is nothing that protects patients from unsafe and ineffective drugs and medical devices.
AIDS Action is concerned that the following provisions in S. 830, as passed out of the Labor and Human Resources Committee on June 18, will jeopardize the health of people living with HIV by weakening the FDA's authority to ensure that AIDS drugs are safe and effective.
- This bill would lower the standards for the approval of new drugs. This bill would allow fewer clinical trials for new drug approvals even though the FDA already allows, when special circumstances dictate it is in the public interest to do so, new drugs to be approved based off fewer clinical trials. The FDA defines narrowly when one trial is enough. This bill does not. It would allow fewer trials for all new drug applications raising the chance that an unsafe and/or ineffective drug will reach the market.
- This bill would allow drug makers to market their products based solely on cost comparisons with similar drugs. Such marketing would not require disclosure of the relative effectiveness of the marketed drug compared to other drugs that treat the same condition. Further, it would not require disclosure of the drug's particular side effects compared to other drugs in its class. As the new standard of care guidelines for HIV therapy show, it is important for people living with HIV and AIDS to have access to all anti-HIV therapies. There is no one combination of AIDS drugs that is effective for everyone. Limiting access to these life-saving drugs based solely on cost puts people living with HIV and AIDS at risk and endangers their lives.
- This bill would permit less evidence for the approval of drugs which treat serious and life-threatening illnesses without requiring drug makers to continue to test their drug after approval to make sure it is doing what they claim it should. People with serious and life-threatening illness, like HIV disease, are willing to take greater risks in order to have access to new drugs more quickly. The FDA has developed a process that allows approval of these drugs based on less stringent criteria. FDA rules already allow drugs for serious and life-threatening illnesses to be approved based on strong initial clinical data under the accelerated approval process. Current rules, however, require companies who have a drug approved under this process to complete post-approval trials to confirm the drug is having the intended affect. S. 830 does not include the post-approval study requirement. It is important that drugs for people living with HIV and AIDS that were initially approved with minimal clinical data are studied after approval to see that these medications continue to have the effect claimed on their labels.
- These "reform" measures threaten the reauthorization of the Prescription Drug User Fee Act (PDUFA). 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 more quickly. PDUFA charges drug makers fees whenever they apply for FDA permission to test a new drug. 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 reach the market for sale. To ensure PDUFA'S continuing success, Congress needs to reauthorize this life-saving program by the end of September. However, by tying controversial FDA "reform" legislation to PDUFA reauthorization, Senate Republicans are threatening the 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.
AIDS Action, along with other patient advocates, support a strong, efficient FDA that brings safe and effective drugs and medical devices to patients as fast as possible. It is unacceptable and irresponsible, however, to bring an unsafe or ineffective drug or medical device to market for use by patients. For many years, AIDS advocates criticized the FDA for moving too slowly or being too bureaucratic. Responding to those criticisms, the FDA has cut in half the time it takes for new drugs to be approved while preserving the high used to determine whether new drugs are proven safe and effective.
Status of Senate FDA "reform" bill:
The Labor and Human Resources Committee, chaired by James Jeffords (R-VT), passed S. 830 on Wednesday, June 18. Four key Democrats -- Dodd (CT), Mikulski (MD), Wellstone (MN), and Murray (WA) -- voted with all ten Republicans for this bill. S. 830 will be scheduled for a vote on the Senate floor within the next two weeks. It is important people contact their Senators to tell them to stop threatening the health of people living with HIV and AIDS.
Your calls and letters are needed now! Please call AND write (on your organizations letterhead) your Senators and tell them to:
VOTE NO on S. 830 because it:
- Lowers the standard for new drug approvals;
- Eliminates important patient safeguards which protect consumers from ineffective or dangerous drugs; and
- Threatens the reauthorization of PDUFA.
Use the points outlined above to help you with your calls and in constructing a letter of opposition to S. 830.
Call the senate switchboard at 202-224-3121 to be connected to you Senator's office.
For more information, call Chad Lord at 202-986-1300, ext. 3062.
For information, contact:
AIDS Action Council
1875 Connecticut Avenue NW #700
Washington DC 20009
202-986-1300, extension 3042