Ronald Bailey at Reason has an article about the costs of the FDA black box warning on antidepressants:
Excessive caution is risky, too. Back in 1992, Congress, worried about the slow rate of approvals, passed legislation imposing FDA user fees on pharmaceutical companies. Flush with these new funds the agency hired 1000 additional drug reviewers and slashed new drug review time from 30 months to 15 months. Now critics claim that the FDA is in the thrall of drug companies and is endangering the public’s health by rushing dangerous new drugs onto the market. As evidence they cite the dangerous side effects of the painkiller Vioxx, the antipsychotic Zyprexa and more recently the diabetes drug Avandia. Sen. Chuck Grassley (R-Iowa) in a letter to the agency in September, 2006, declared, “Under the current FDA review system, patient safety takes a back seat to the fast approval of products.” Critics like Grassley believe that the FDA should err on the side of caution.
And in fact, recent criticism appears to have made FDA regulators more timid. According to a 2005 JAMA report, “It does seem indisputable that there have been shifts in the acceptable threshold for risk/benefit for many diseases as the depth of scientific understanding increases and as information about the effects of drugs on large patient populations is more readily available.” One disturbing consequence of this shift in the risk/benefit threshold is that for drugs approved in the first half of 2005, the average time from application to approval was 29 months. This is up from an average of 16 months for drugs approved in the first half of 2004. Why the slowdown? Because, as Harvard Business School professor Regina Herzlinger explains in her May 2006 article Why Innovation in Health Care is So Hard (not online): “Officials know they will be punished by the public and politicians more for underregulating — approving a harmful drug, say — than for tightening the approval process, even if so doing delays a useful innovation.”
But if slower regulatory approvals are the price we need to pay for safer drugs, surely that’s a good tradeoff. Not really. A fascinating 2005 study by University of Chicago economists calculated that the speed up in FDA drug approvals that occurred after 1992 may have been responsible for saving the equivalent of 180,000 to 310,000 life-years. On the other hand, the economists estimated that at worst, about 56,000 life-years were lost to drugs that were eventually withdrawn for safety reasons. Unfortunately, it’s much easier to identify people who are harmed by drugs than those who are saved by drugs. In the face of this information asymmetry regulators focus on reducing lives lost to unsafe drugs rather than preventing deaths by speeding effective new therapies to patients. (Emphasis mine.)
Read the whole thing. I talked about the black box warning here.
Here’s a crazy idea. How about we limit FDA approval to just phase 1? (Phase 1 is where drugs are tested for toxicity, but not effectiveness.) Because I was under the impression that its purpose as an agency was to save lives, and it would appear that it is doing the opposite. And just think of how many more new drugs would go on the market when we cut the time and the cost of FDA approval…