And speaking of benefit/risk ...

  • by: |
  • 05/02/2012

BioCentury reports:

IOM: FDA should consolidate benefit-risk data for each drug

The Institute of Medicine said FDA should consolidate benefit-risk information for approved drugs into publicly available repositories created for each product. In a report released Tuesday, IOM said the agency already collects much of the information needed but that it is spread across multiple records. The report recommended the creation of a publicly available document containing information for each product from its approval throughout its entire time on market, including safety issues, regulatory actions and any restrictions. FDA said in a statement it supports the general concept, but added that it would be "very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities."

IOM also noted in the report that there is no universal set of criteria to determine when FDA should require a postmarketing study to evaluate a drug's safety. However, the report noted that the agency should require additional post-marketing safety research when a drug's benefits or risks are particularly uncertain, including first-in-class drugs approved based on surrogate endpoints, drugs for which endpoints provide conflicting evidence about risk or drugs with a strong biological rationale for a particular side effect. IOM, which conducted the review at FDA's request, issued a preliminary report in 2010.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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