(30) APhA-ASP strongly encourages the FDA to make available the bioequivalence/bioavailability studies performed for generic drug approval.

R2 PRT: Availability of bioequivalence studies - Wording/action:
(30) APhA-ASP strongly encourages the FDA to make available the bioequivalence/bioavailability studies performed for generic drug approval.

Reasons for the Action(s) / Pros and Cons:

Generic drug manufacturers are now involved in the production of more than half of medications prescribed to patients, and as a result pharmacists in every healthcare setting are dispensing generic medication with the promise that the significantly lower price does not manifest itself as a compromise in therapeutic equivalence. Pharmacist’s access to this information will allow for the assessment of appropriate substitutions for brand name medications, and optimize the level of care available for patients.

The FDA acknowledges that because a large number of manufacturers make generic drugs, the chance exists that a number of drugs not truly equivalent to brand-names could reach the market, distorting the continuity of care when switching from one manufacturer to another. New generic drugs are not tested by the FDA against each other, but tested only against the brand name, making it possible that multiple generic medications could meet quality standards, although they could be significantly different from each other.

Joseph Demers & Aditi Shukla ; 732-618-7482 ;
JosephP.Demers@gmail.com, Aditi.N.Shukla@gmail.com ;
University of the Sciences in Philadelphia