Thursday, January 19, 2006

Changes Proposed for Drug Patents

According to Reuters Heath Information, reported on Medscape, experts testifying before a panel from the Institute of Medicine has suggested that drug safety could be improved by granting a patent extension to companies that comply with recommended post-marketing safety studies.  Apparently, the Institute of Medicine was asked to make recommendations, after the trouble with Vioxx, and the stories about antidepressants being associated with increased risk of suicidal thinking in adolescent patients.  They are in the process of preparing a report for the FDA.  
More US Patent Time Suggested for Drug Safety Data (free registration required)
The U.S. government should consider extending patent protection on pharmaceuticals if drug makers conduct new safety studies after a product reaches the market, scientists told an expert panel on Tuesday.

Regulators often request additional studies of drug side effects after medicines are approved. In most cases the research is voluntary.

Lengthening patent life could provide a needed incentive for companies to complete the studies, some academic experts told an Institute of Medicine panel that is studying the Food and Drug Administration's drug-safety monitoring.

Patent extensions have been successful in enticing firms to study how their medicines behave in children, scientists said. Companies can secure hundreds of millions of dollars in added sales for the six-month patent extensions they win in exchange for pediatric studies.

"If you do what's required, you'll get an incentive in your patent life. We know it's worked" for pediatrics, said Dr. Alastair Wood, a clinical pharmacologist at Vanderbilt University Medical Center. [...]

Personally, I would favor the proposal I made a while ago, that pharmaceutical companies could get liability protection in exchange for ongoing safety studies.  True, the patent extension is attractive, mainly because it already has been shown to work (in the case of pediatric safety studies.)  Still, the incentive of liability protection seems more attractive to me, if only because it ties the incentive more directly to the purpose of the additional studies.  That is, in exchange for the companies' effort to reduce the risk to patients, they get reduced risk of liability for safety problems.