FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

The US Food and Drug Administration (Rockville, MD, www.fda.gov) published several long-anticipated documents last month that aim to encourage the development of safer drugs and to promote the appropriate use of medicines by patients and prescribers. The timing may be favorable for Acting Commissioner Lester Crawford, who can cite these accomplishments to show Congress that FDA will be more innovative and aggressive in ensuring drug safety under his leadership.

Three new guidances on risk minimization clarifiy ways to assess drug safety issues during premarket testing and after a new drug comes to market. These documents finalize draft proposals published last year following a public workshop in May 2003.

One guidance proposes additional testing and study approaches during clinical development that are likely to enhance a sponsor's understanding of safety concerns. Another document describes development and use of "RiskMAPS" to ensure safe product use by patients. The third guidance encourages good pharmacovigilance practices. The guidances are available at www.fda.gov/cder/guidance.

FDA separately unveiled a much-anticipated guidance on how sponsors should submit pharmacogenomic data to the agency, either as part of market applications or through a new voluntary process that aims to encourage pharmacogenomic research leading to "personalized" medicine. This document, along with additional information for submitting data to FDA and FDA's assessment process, is available on FDA's Web site.

–Jill Wechsler