FDA Needs A Lot Of Shaking Up
September 30, 2002
Critics say the Food and Drug Administration's problems are legion, ranging from careless scientific reasoning to outright bureaucratic incompetence.
The agency's original charter was to keep harmful drugs out of patients' hands. But in practice that has come to mean "protecting" people from drugs that could save their lives. To take just one example, in June 2000 the FDA had two drugs ready for approval within six months to treat a rare, fatal disorder called Fabry's Disease. But although 15 countries in Europe already approved the drug, the FDA put it on hold for more data. In the mean time, 15 people with Fabry's have died waiting for the medicine.
Here are some of the specific charges:
- Too many biotech products are endlessly sidelined by requests for unnecessary data.
- The agency often insists on clinical trials and group comparisons that are scientifically inappropriate for individual therapies like cancer vaccines, or for biologic-based products that target special proteins or molecules within individual cells.
- The agency's decision-making is so lethargic that we actually lag behind Europe and Japan in the time it takes to approve new biotech drugs.
- No wonder, experts say, the cost of developing a new drug has doubled from $400 million to $800 million in the last decade.
The critics recommend several steps to bring the agency into the 21st century. They say getting the agency fully computerized would be a good start.
Seeking out advisers and expert panels staffed with actual scientists, practicing doctors and statisticians who specialize in medicine would advance the cause.
The FDA should work in concert with patient groups and companies to track outcomes and impacts after a drug has been certified safe in humans, experts recommend.
Source: Robert Goldberg (Manhattan Institute), "FDA Needs a Dose of Reform," Wall Street Journal, September 30, 2002.
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