Opinion: Memo to von Eschenbach - Pharmaceutical Executive

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Opinion: Memo to von Eschenbach
FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.


Pharmaceutical Executive


Hold pharma to post-approval commitments In some cases, FDA agrees to approve a new drug on condition that the company conducts post-approval marketing studies—for example, to provide additional data on the drug's safety and efficacy in specific patient groups. Often, these studies don't materialize, in part, because drug companies question their value or because FDA doesn't have the resources to follow up. Independent review of the need for such studies would address industry's concern that requested studies may be unwarranted. FDA should devote adequate resources for ensuring that requested studies are conducted, that submitted data receive quick and thoughtful review, and that any necessary action regarding a drug's fate is taken expeditiously.

Renew focus on Critical Path FDA's Critical Path initiative seeks to improve pharma R&D by reducing late-stage research failures and speeding new, safe, and effective drugs to market. This program, which has elevated the level of interaction between FDA and drug developers, had a promising start. This should not be allowed to get sidetracked. (See "What Ever Happened to Critical Path?")

Launch proactive risk-assessment programs Today, the United States relies on private physicians to identify potential drug-safety problems and report those problems to FDA. This passive approach to post-marketing drug surveillance should be supplemented with a proactive system, similar to the direction taken by FDA's European counterpart, the European Medicines Agency. FDA should work with industry to develop risk-assessment programs, which could become part of a company's application for a new-drug approval. For example, random patient surveys by a third party could help create profiles of patient outcomes on specific drugs and safety problems associated with the use of those drugs.

Ensure that DTC ads communicate drug risks While these ads typically provide information on the benefits and risks of specific drugs, they can also play an important role in educating consumers on the benefit-risk balance inherent in the use of all prescription medicine. Consumers should understand that no drug comes without a certain degree of risk, and the level of risk one is willing to assume should be balanced against the benefit that the drug provides. That decision is typically in the hands of the patient and their physician.

As long as there are new drugs approved, there will be some that are withdrawn due to unforeseeable safety problems. Although the benefits of the vast majority of prescription drugs in the United States far outweigh the associated risks, drug companies and the public have an equally strong incentive to understand those benefits and risks to the greatest extent possible. Doing so will lower development costs and improve patient outcomes, to the advantage of all.

Kenneth I. Kaitin is director of the Tufts Center for the Study of Drug Development. He can be reached at


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