The Silent "n" of PDUFA

  • by: |
  • 05/13/2015

Statistics are like a bikini. What they show you are interesting, but what they conceal is essential.

Late last month the FDA’s Bioresearch Monitoring (“BIMO”) Program released its annual report on inspections from the previous fiscal year. 

In light of many key issues and initiatives, some of the results are, well … thought provoking.

For example:

·      Following well-publicized recalls of bioequivalent but therapeutically unacceptable generic versions of Budeprion and Metoprolol, the agency reported a 7% decrease in bioequivalence inspections (205 in FY13 and 190 in FY14). Something for the new Office of Pharmaceutical Quality to think about.

·      Can you say “Ranbaxy?” BIMO shows only paltry changes in international inspections from the drug side (CBER down 1 inspection – 24 in FY13 and 23 in FY14 and CDER up a dozen -- 202 in FY13 and 214 in FY14). It’s not the “n” it’s only the beginning.

With PDUFA reauthorization conversations getting under way, these and other metrics are going to be discussion starters and debate drivers. The complete report is worth a read.


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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