Industry officials disputed the notion that the FDA has become less aggressive on safety issues.
The small number of drug withdrawals since 2001 reflects the fact that fewer new drug applications have been submitted and approved, and that the FDA has been more active in looking for signs of liver- and heart-damaging side effects before approving new drugs, said Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA). As a result, some potentially dangerous drugs never made it to the market, he said. The FDA has required stricter monitoring and management of patients to minimize the risk for others, he added.
"Drugs are approved based on an evaluation of both the benefits and the risks," Goldhammer said. "There is no drug on the market without some risk."
He argued that the post-marketing surveillance system, which requires manufacturers to report deaths and life-threatening reactions to drugs within 15 days, is working well. The real problem, he said, is how to draw conclusions from that data, which is why PhRMA has been working with the FDA for more than a year to improve data-mining techniques for combing through computer databases to find patterns.
When Congress introduced drug industry user fees in 1992, all the money was earmarked for hiring people to speed the drug review process. It was not until 2002 that Congress allowed some of the money to be used to boost post-market drug safety surveillance.
The 2002 funding package set aside $75 million over five years from user fees to add more than 100 positions to the drug safety office, Goldhammer said.
The user fee funding has shortened the average time for new drug reviews from 32 to 13 months, with some priority drugs passing muster in six months, he said, but that has not led to less careful reviews.
"The FDA spends more than $2 million doing a new drug review," he said. "That's 13 person-years looking at safety, efficacy and the manufacturing process. That is a significant effort that has been lost in this whole debate."
