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Dear Commissioner...


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-04-01-2009
Volume 0
Issue 0

Unsolicited advice for FDA's next leader: Keep it real, fight popular delusions, and somehow, please, defend the agency.

As I write this, it appears that we're on the verge of having a new FDA commissioner—and a potentially good one. Margaret Hamburg, who will bring to the job experience as a former New York City health commissioner and biodefense expert, offers a good mix of scientific rigor and administrative savvy. There's reason to hope that her reputation for caring about patients and public health will buy her at least a short period of uninterrupted work before the micromanagers on Capitol Hill, the conspiracy theorists in the press, and the Marcia Angells of the world come howling for her blood.

Patrick Clinton

I'm sure that as her confirmation hearings approach, Dr. Hamburg is receiving reams of advice from all sides. Here's my addition to the pile:

Remember the mission—FDA's, that is. Yes, safety, efficacy, and security are the core of the first sentence of the agency's mission statement. But here's the second: "The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." In other words, helping drugs to market isn't just pandering to the industry. It's part of the mission.

Remember that there are two types of error, not one Keeping a good drug off the market is just as much a mistake as letting a bad one on. And in many cases, the cost in human life and suffering can be just as great. It is, apparently, human nature to care more about the type two error than about type one. But that's a poor basis for policy.

Be realistic about safety The public has decided that drugs should be safe in the way consumer products are safe, and that a drug that causes an injury is somehow a defective product. The public is wrong. FDA's approach to safety—that the agency will oversee companies in providing the best available information about pharmaceutical products, and that doctors and patients together will make the safety decision—is the right way to go. But it isn't working. The problem won't be solved by "cracking down" on safety, but rather by getting doctors and patients to accept the responsibility imposed on them by the availability of new and not-fully-understood drugs. The alternative is to withhold needed treatments from even the most motivated and risk-smart patients.

Rely on facts In several highly visible areas, FDA makes decisions that are frankly based on guesswork. How do DTC ads hurt or benefit patients? What impact do warnings have on patient outcomes? I don't think we actually know, and that needs to change. The point of regulation is not to make things logical or to placate critics—it's to make things work.

Defend FDA's authority One of the glories of the American marketplace is its sheer size—and the consistency of regulation from state to state. In the wake of Wyeth v. Levine, there's good reason to fear that pharmaceutical products will come to be regulated on a state-by-state basis. Whatever the public's concerns about FDA, there is no chance that state-level decisions about drugs and drug marketing will ever measure up to what the agency provides, and the cost of regulation times 50 is too awful to contemplate. FDA needs to hang on to its traditional realm of authority.

It's sad but true that the new commissioner's job may prove to be less about protecting the public and more about guarding the agency. But that job matters. May she succeed.

Patrick Clinton



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