Endocrine Insider
April 15, 2010

(See Full Issue)

Society staff attended a meeting of the Food and Drug Administration‘s(FDA) Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) on April 13 and 14. ACPS-CP convened the meeting to discuss topics related to bioequivalence of brand name and generic drugs and to make recommendations to the FDA on changes to bioequivalence policy. 

The committee heard from the FDA about revising the bioequivalence approaches for critical dose drugs, and voted 13-0 to recommend to the FDA that a list of narrow therapeutic index drugs be created.  Additional presentations on the topic of bioequivalence resulted in the committee voting 11-2 that the current bioequivalence standards for narrow therapeutic drugs are not sufficient and it was suggested that the standards need to be stricter.

FDA presenters referenced a 2008 Endocrine Society position statement [link] in which the Society urged FDA to rescind its current determinations of bioequivalence among L-T4 products and instead announce that the products have not been shown to be bioequivalent.  Under current determinations, patients may be placed at risk if their L-T4 prescriptions are switched between brands, from brand to generic, or from one generic to another without the knowledge or consent of their physicians.  Society staff were encouraged by the position statement reference and by the committee’s recommendation that bioequivalence standards should be stricter. The Society will offer its assistance to the FDA as they consider the advisory committee’s recommendations and implement any changes to the bioequivalence standards for narrow therapeutic drugs