Science/Technology blog

Over the last year or so, the US FDA has grown tougher on withdrawing prescription and over-the-counter drugs that have not met the modern burden of proof for safety and efficacy that was officially required by the 1962 passage of the Kefauver-Harris amendments to the 1906 Federal Food and Drug Act (WaPo overview from June 2006 here). This legislation not only gave us the modern structure of preclinical and clincal trials, but it also required that drugs sold previously between 1938 and 1962 had to meet this standard of proof of safety and effectiveness.

But, it didn’t make financial sense for these companies to be required to submit to the full battery of preclinical and clincal tests required of new drugs. So in 1966, the National Academy of Sciences convened a special group to assess the existing clinical literature on 4,000 of these drugs and the FDA took their recommendations to keep or ban these agents in 1968 by forming the Drug Efficacy Study Implementation (DESI). Very common drugs like aspirin and acetaminophen were “grandfathered” in under this literature review process.

Not well-appreciated was that the FDA did ultimately require companies selling these drugs to conduct prospective clinical trials within some ill-defined timeframe. Drugs like phenobarbital for epilepsy and chloral hydrate for sedation and alcohol withdrawal are two examples of drugs that continue to be sold as “unapproved” drugs. However, there was little financial incentive for a drug company to support such trials and the FDA had for many years a rather relaxed attitude toward these agents. But, as the FDA notes:

“[F]or a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).

“While some unapproved drugs may have benefits, there may also be risks. Patients and health professionals should carefully consider the medical condition being treated, the patient’s previous response to the drug, and the availability of approved alternatives as part of discussing the benefits and risks of any unapproved treatment. “

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