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November 27, 2007Safer than what?Reuters reports today that an FDA "medical officer" is publicly calling for the FDA to change its standards for approving new drugs. Currently, companies commonly test their medicines against placebos to prove that they are "safe and effective" for sale in the U.S. Dr. Robert Misbin would like new drugs to be tested against drugs for the same indication that are already on market: "You can't really evaluate a drug in a vacuum; you have to evaluate it in comparison to something," Dr. Robert Misbin, a medical officer in the FDA unit that reviews diabetes drugs, said in an interview. ... Companies have no incentive to test their drugs against rivals, and so the FDA should require them, given the efficacy of current treatments for diabetes, Misbin said. Pharmaceutical companies in recent months have complained that the FDA is raising the bar for approving new drugs by in effect comparing experimental treatments with current therapy. But a top FDA official told Reuters earlier this month that although there is a renewed focus on safety, the agency always has taken comparable drugs' safety record into account when reviewing drugs. Misbin wrote that although the FDA doesn't have the authority to require that a new drug be superior to existing treatments, the FDA "is not required to have proof that a new drug is unsafe to deny approval." This is a terrible, terrible idea. What drug will the FDA require as the comparator? The leading drug in its class? That's basically giving the market leader a monopoly, because no drug company is going to waste $1 billion and ten years developing a new drug candidate that might not get to market because of a competitor drug, i.e. companies won't know whether their drug is "saleable" until the head-to-head comparison is completed, a massive financial bet that no rational company would make. And what population is the FDA going to require companies to test the drugs in? At what dosage? Drugs may have different benefits and risks for different populations; so what looks unsafe in one group might be a better drug for another group, or at a different dosage. The complications facing trial designs like this would be a nightmare, with regulators and competitors second guessing challengers every step of the way. No one in the media ever seems to realize that Misbin's argument cuts both ways: not all drugs are equal, so, all things considered, you want more options not less so that when unexpected safety problems crop up you can switch patients to other alternatives. It is true that the full benefit and risk profiles of some drugs may not be known for several years after they are on the market and used in large populations - this is precisely when rare safety signals pop up. Instead of putting new hurdles in front of drug developers, we should be working on developing better tools - like safety biomarkers - to help companies develop safer drugs in the first place, and to give patients and doctors more guidance in how they prescribe drugs. Misbin's proposal hits the bad idea trifecta: it's bad for patients, bad for medical innovation, and bad for the FDA, who would be in the position of defending monopoly profits for existing manufacturers.
Posted by Paul Howard at November 27, 2007 12:38 PM CommentsPost a comment |
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