The Federal Trade Commission (FTC) has offered its support for revised US Food and Drug Administration (FDA) draft guidance that will use additional criteria to determine if a citizen petition was submitted to delay the approval of a competing drug.
The revised draft offers new considerations for FDA when reviewing citizen petitions, including if a petition was submitted near the expiration of known patent or exclusivity, if a petition was the same or substantially similar to a prior petition or if the petition’s scientific positions were unsupported by data or information.
“Each response to a petition must be prepared, reviewed, and vetted by staff across the FDA. Although some citizen petitions raise genuine issues for scientific consideration, many petitions do not and are denied for lack of merit,” the FTC explains.
The FTC also notes the need for the revised guidance, because although Congress in 2007 enacted Section 505(q) of the Federal Food, Drug, and Cosmetic Act,
which requires FDA to respond to petitions within a specified timeframe, meeting the statutory deadlines “has placed a significant resource burden on the FDA and has forced it to redirect resources from other work.”
Mylan, which noted the passage of 505(q) was to stop the abuse of the citizen petition process, believes the revised draft guidance narrows the scope of 505(q) too far. The company expressed concerns that such a narrow interpretation “undermines the very purposes of the statute and is contrary to law.”
Industry group PhRMA, while praising some aspects of the revised draft, also took issue with FDA’s new policy on when it will decline to issue a substantive response to a petition.
“FDA announces the new position – which the agency is apparently already applying – that it is not required to make a substantive determination on a petition if (a) the petition involves an issue regarding the approvability of a specific ANDA or 505(b)(2) application; and (b) the 180-day review deadline will elapse before FDA has made a final determination on the approvability of the generic application. PhRMA believes that this new policy is unjustified, conflicts with section 505(q), and creates perverse incentives that undermine reasoned decision-making and the availability of judicial review,” PhRMA said.
Allergan, which had three citizen petitions denied
after attempting to block generic versions of its blockbuster Restasis (cyclosporine ophthalmic emulsion), also took issue with FDA’s current “non-substantive” denial approach to Section 505(q), which it said, “leaves entirely unclear whether the Agency has actually made any decisions about issues raised in a petition (or whether the issues are still under evaluation) and provides no assurance that specific issues will be addressed at or before the time that a generic drug product is approved.”