In a letter dated November 27, 2013, the Generic Pharmaceutical Association (GPhA) requested a 60-day extension to provide comments on the FDA’s Proposed Rule – Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.
GPhA noted in their request that:
“The proposed rule includes revisions that would dramatically alter the current regulations governing generic drugs with respect to both when and how a labeling change would be required. The changes as proposed will have far reaching consequences affecting patient safety as well as health care costs. They also create an additional burden not anticipated in the business and compliance models of generic and biosimilar manufacturers and marketers.” GPhA requests this extension “to afford all interested stakeholders an opportunity to provide commentary based on a robust analysis of the various legal and commercial implications of the proposal.”
The letter, signed by Ralph G. Neas, President and CEO of GPhA, also cited the complexities of the issues raised as well as the upcoming holidays and its impact on assuring sufficient time to provide reasoned comments to the proposed rule.
In a previous post (here), I discussed the significant impact on the generic industry, FDA and some of the legal questions that this proposed rule raises. Outside of the GDUFA legislation which has changed the face of the Office of Generic Drug (OGD) review and approval process, this Proposed Rule could change the way generic companies have done business since 1984 (and before). The unintended consequences of what many in the industry see as a major game changer for themselves and OGD, as well as the implications for liability that this proposed rule may create must be evaluated in a systematic and reasoned process to assure the balance struck by Hatch-Waxman Act between the Brand Name and Generic industries is not thrown out of whack.
