This article highlights a 1997 FDA reform that speeded patient access to important new treatments for serious and lifethreatening diseasesa welcome reflection on the importance of drug access at a time when many critics have taken the FDA to task for approving products too quickly.
Revlimid can't cure Alice Duggins, but it can buy her time. Duggins has a blood disorder that can lead to leukemia, and while she waits for a bonemarrow transplant, Revlimid boosts her redbloodcell count. Not even blood transfusions would help, said Duggins, who lives in Walnut Cove. "It would be like putting gas in a tank that has a hole in it."
Revlimid is among a number of drugs that have gotten fasttrack approval from the Food and Drug Administration under a law sponsored by Sen. Richard Burr 10 years ago, when he was a member of the House of Representatives. Among other things, the bill gave drug companies a way to get some critically needed drugs to the head of the line for approval and lifted certain marketing restrictions on offlabel uses of drugs already approved.
The FDA has reduced the time it takes to approve new drugs, but the number of approvals hasn't increased significantly. "This is absolutely a better process than it was," said Bayard Powell, the chief of the hematology and oncology section at Wake Forest University Baptist Medical Center. The reforms have been particularly important for cancer patients, Powell said.
No law is perfect, Burr said, but he thinks that the FDA modernization has been a success. Later this year, Congress is expected to take up its fiveyear reauthorization of the law, giving legislators a look at its strengths and weaknesses and its critics a chance to push for changes.
The reauthorization is taking place at a time when pharmaceutical companies are both powerful and vulnerable and prescription drugs are more important than ever to health insurance and consumers.