GPhA criticism of US NIH over PHS Act implementation

The US Generic Pharmaceutical Association (GPhA) has written to the National Institutes of Health to express concerns as to whether a  company submitting an Abbreviated New Drug Application (or a 505(b)(2)  application) containing the results of an in vivo bioequivalence study  must certify on Form FDA 3674 that new Public Health Service Act's  Section 402(j), as added by Title VIII of the Food and Drug  Administration Amendments Act, applies and that in vivo bioequivalence  studies have to been registered at the NIH's on-line clinical trial  registry (ClinicalTrials.gov).

The relevant legislation defines an "applicable drug clinical trial,"  which is subject to the database registration requirements, to mean "a  controlled clinical investigation, other than a Phase I clinical  investigation, of a drug subject to [Food Drug and Cosmetics Act  Section 505]." Kurt Karst, a lawyer with specialist law practise Hyman,  Phelps & McNamara, noted that the NIH's interpretation of of the new  Public Health Service Act provides grounds for concerns for ANDA  sponsors.

The GPhA has requested in a letter to the NIH that the federal body  clarify that a clinical endpoint bioequivalence study should not be  considered an "applicable drug clinical trial," which a December  2008, NIH draft document, titled: Elaboration of Definitions of  Responsible Party and Applicable Clinical Trial, appears to indicate  would be the case in some circumstances. The draft "elaborations"  document was updated in March 2009 to clarify that it "represent[s] the  [NIH's] current thinking on this topic."