Improve Post-Market Safety, Improve a Drug's Entire Life Cycle

The drug industry and its watchers often define success as the approval of a new product or indication. The FDA's responsibilities don't end there, however.

Writing in Perspectives, Steve Grossman notes that the agency's mission includes "determining whether already-approved drugs perform safely and effectively when used by large numbers of patients in routine medical practice."

The problem is, post-market surveillance utilizes data that's neither easily obtainable, objective, nor complete. To bolster this effort, the FDA has been developing a monitoring system called Sentinel, which incorporates not just claims data but medical records and patient registry information.

Mr. Grossman argues that a more comprehensive system such as Sentinel would greatly improve the entire life cycle of a biopharmaceutical product, and benefit all stakeholders at the same time.

After-market assurance, for example, would likely increase the FDA's drug approval rate, in particular of those on-the-fence products that clinical trials don't complete satisfy.

Read Mr. Grossman's article "Standing 'Sentinel': The FDA and Post-Market Safety" here.