Thursday, November 18, 2004
A blessing or a curse?
[Marc Kaufman and Brooke A. Masters, "FDA Is Flexing Less Muscle," The Washington Post, 18 November 2004.]
As if in response to the post yesterday on an overbearing FDA, this article appeared today in The Washington Post:
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health.
The spin here is that the agency has been captured by the industry. Since Congress decided that pharmaceutical companies would be picking up a decent chunk of their own approval costs, this is not an altogether outrageous concern. Nonetheless, it is important to not confuse a lack of disciplinary action with a lack of regulation:
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.
"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."
What is also left out of this discussion is the loss of lives and incentive to innovate as a result of a slow and burensome regulatory process. We have to recognize that there are trade-offs involved in the current level of oversight, and that the benefits of speeding up the process may outweigh the costs.
[Marc Kaufman and Brooke A. Masters, "FDA Is Flexing Less Muscle," The Washington Post, 18 November 2004.]
As if in response to the post yesterday on an overbearing FDA, this article appeared today in The Washington Post:
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health.
The spin here is that the agency has been captured by the industry. Since Congress decided that pharmaceutical companies would be picking up a decent chunk of their own approval costs, this is not an altogether outrageous concern. Nonetheless, it is important to not confuse a lack of disciplinary action with a lack of regulation:
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.
"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."
What is also left out of this discussion is the loss of lives and incentive to innovate as a result of a slow and burensome regulatory process. We have to recognize that there are trade-offs involved in the current level of oversight, and that the benefits of speeding up the process may outweigh the costs.
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