- The Washington Times - Tuesday, September 26, 2006

The Food and Drug Administration (FDA) will behave a lot more like the Environmental Protection Agency (EPA) if Congress and the FDA adopt recommendations of last week’s Institute of Medicine (IOM) report. And that is dangerous news for consumers who need a steady flow of innovative medicines.

IOM recommendations that newly-approved drugs should carry a black triangle for their first two years on the market, and that advertising of new drugs be restricted, are the wrong approach to perceived safety issues.

Do we really want the FDA to start acting like the EPA, which treats all new chemicals with great suspicion?

The underlying problem with the EPA is that their incentives are misaligned: EPA officials are blamed any time there is even a potential negative effect of under-regulation, yet are never held responsible for the huge costs of overregulation. Under this one-sided incentive approach, it is no wonder the EPA behaves as it does. In the absence of absolute proof of a substance’s safety, it is “better to be safe than sorry,” according to the EPA and other proponents of the so-called “precautionary principle.” The EPA applies this rule regardless of the costs of keeping useful products out of the hands of consumers. The EPA isn’t called to task for the myriad costs, in both money and quality of life, of regulations meant to protect us from remote risks.

If applied by the FDA, the precautionary principle could keep patients from getting lifesaving drugs. Already, the same bad incentive system the EPA works under is at play at the FDA to some extent. Many would hold the agency accountable for every alleged side effect from a prescription drug. Yet FDA is never called to account for the unnecessary deaths of patients who don’t get the new drugs they need in a timely way because of hypercautious regulatory delays in getting drugs to market. The IOM’s proposed policy changes for the FDA would only further institutionalize the one-sided incentive system that has already been failing the public at the EPA.

Another ill-advised IOM recommendation would further skew the regulatory process — a call for at least 60 percent of medical experts serving on FDA advisory panels to be free of “significant” financial involvement with pharmaceutical companies. Yet most truly qualified experts have at one time held significant relationships with pharmaceutical companies. The FDA needs more and better experts, not more restrictions on those most qualified to serve. Instead, the IOM should have simply demanded that 100 percent of FDA panel members have true expertise in evaluating drug safety and efficacy. Any actual effect of alleged bias — be it from financial or other causes — should be weeded out during thorough committee review.

To assume all scientists who have worked with industry are corrupt and ban them from review panels would leave only a strange subset of scientists — weighted toward those who were ardently anti-industry or lacking the expertise that would inspire companies to hire them as consultants — to decide when a company could be trusted to put a new drug on the market. This is surely a formula for excessive caution.

It seems that when it comes to our health, zero risk is the only level some people will accept. Yet we know that we engage in risky behavior every day. From crossing the street to exercising, there is always some danger in our everyday activities. But not taking risks opens us up to a whole new set of dangers. For instance, it would be absurd not to exercise out of fear of an injury. We know that such a precautionary approach would do more harm than good. Yet there is now pressure to apply this unwise approach to more complex regulatory matters.

Jeff Stier is an associate director of the American Council on Science and Health (ACSH.org).



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