Create a no-fault period of probation for new drugs

Regarding "Former FDA commissioners meet to discuss current agency woes" (Article, March 26): Several strategies to improve the performance of the FDA were espoused, including rethinking of the entire pharmaceutical development process, as urged by David Kessler MD; returning to scientific reasoning in making decisions as advocated by Jane Henney, MD; developing a national registry for adverse drug reactions as advocated by Donald Kennedy, PhD; and recruiting commissioners in a professional fashion rather than as political appointees as proposed by Frank Young MD, PhD.

I also would urge discussion of creating a probationary period for newly marketed drugs with a term for that probation to be set by the commissioners to best fit the need for postmarketing surveillance. Patent dates could begin at the end of the probationary period and during the probationary period. People suffering harm could be compensated under a no-fault system similar to the fund to compensate those suffering harm after required immunizations. This fund could be capitalized by the drug manufacturers as a pool. Reinsurance might be necessary.

This system also might be designed to give reasonable compensation to people who suffer an event that may have been an adverse drug reaction result of pre-existing pathology, which would have occurred even if the drug not been taken (e.g. myocardial infarction in a patient receiving Vioxx) without meeting the test in civil litigation that the event was more likely than not to have been caused by the drug.

Persons receiving a new drug still on probationary status could receive this status notification as informed consent from the prescriber as well as in accompanying printed material packaged with the drug. Taking the drug after receiving these notifications could constitute the treated person's agreement to be compensated by the fund rather than litigating.

I believe this system might allow innovations in pharmcotherapeutics to reach the marketplace promptly after FDA process and approval, yet emphasize to the treated person the inherent dangers of taking a medication that is untested in the real world of patients of all ages, taking other drugs and with all manner of co-morbidities not found in the research samples of phase III studies.

D.A. Smith, MD, Brownwood, Texas

Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/05/21/edlt0521.htm.