Updated House Energy & Commerce UFA Bill Would Shorten FDA’s 505(q) Petition Response Timeframe; Require Timely Responses to RLD Withdrawal Petitions

May 7, 2012

By Kurt R. Karst –     

On Tuesday, May 8th, the House Energy and Commerce Committee, Subcommittee on Health is scheduled to hold a markup session to consider draft legislation to ensure the continuation of existing FDA user fee programs (i.e., PDUFA and MDUFA) and the creation of new ones (i.e., GDUFA and BsUFA).  In addition to the UFAs (user fee acts), the draft legislation includes a host other provisions, including provisions on FDA administrative reforms, drug shortages, medical device regulatory reforms, and drug regulatory reforms.  (A background memo on the nearly 300-page bill, which includes a section-by-section overview, is available here.)  While all of the provisions in the draft bill are of interest, two sections concerning citizen petitions caught our attention.

Section 863 of the draft Energy and Commerce UFA bill would amend FDC Act § 505(q) to shorten the timeframe FDA has to respond to certain citizen petitions.  FDC Act § 505(q), which was added to the law as part of the FDA amendments Act of 2007, provides that FDA shall not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  Under current FDC Act § 505(q), “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”  FDA may not extend the 180-day period “for any reason,” including consent of the petitioner, and may summarily deny a petition submitted with the primary purpose of delaying ANDA or 505(b)(2) application approval. 

FDA has only missed the 180-day timeframe twice between FYs 2008 and 2010, according to the Agency’s most recent annual report (see here) and our popular FDC Act § 505(q) Citizen Petition Tracker.  The draft Energy and Commerce UFA bill would shave 30 days off of FDA’s response timeframe, from 180 days to 150 days.  Is FDA a victim of its own success?

A second provision in the draft UFA bill concerning citizen petitions would establish a timeframe for FDA to respond to requests for an Agency determination of the reasons for a voluntary withdrawal of a listed drug. 

Under FDC Act § 505(j)(4)(I), FDA may refuse to approve an ANDA if the Agency determines that the Reference Listed Drug (“RLD”) was withdrawn from sale for reasons of safety or effectiveness.  In addition, FDA can withdraw (or suspend) approval of an ANDA if the RLD is withdrawn from sale for reasons of safety or effectiveness (FDC Act § 505(j)(6)).  In that case, the RLD is removed from the Orange Book (FDC Act § 505(j)(7)(C)).

As FDA acknowledged in the preamble to the Agency’s July 1989 proposed regulations implementing the 1984 Hatch-Waxman Amendments, the law does not “specify procedures to be followed in determining whether a drug that is voluntarily withdrawn from sale by its manufacturer is withdrawn for safety or effectiveness reasons” (54 Fed. Reg. 28,872, 28,907 (July 10, 1989)).  As such, FDA took it upon itself to create such a procedure.

FDA’s interpretation of the Hatch-Waxman Amendments is embodied in the Agency’s  regulations at 21 C.F.R. § 314.161, which state, in relevant part:

(a) A determination whether a listed drug that has been voluntarily withdrawn from sale was withdrawn for safety or effectiveness reasons may be made by the agency at any time after the drug has been voluntarily withdrawn from sale, but must be made:

(1) Prior to approving an abbreviated new drug application that refers to the listed drug;

(2) Whenever a listed drug is voluntarily withdrawn from sale and abbreviated new drug applications that referred to the listed drug have been approved; and

(3) When a person petitions for such a determination under 10.25(a) and 10.30 of this chapter.

(b) Any person may petition under 10.25(a) and 10.30 of this chapter for a determination whether a listed drug has been voluntarily withdrawn for safety or effectiveness reasons.  Any such petition must contain all evidence available to the petitioner concerning the reason that the drug is withdrawn from sale.

FDA’s timeframe for responding to withdrawal petitions has been all over the board.  In some cases FDA has responded within months (e.g., Docket No. FDA-2011-P-0128), while in other cases it has taken FDA more than three years to respond (e.g., Docket No. FDA-2008-P-0527).  One likely explanation for FDA’s different response timeframes is that FDA only responds to such a petition when it becomes necessary to do so; that is, when the Agency is poised to make an approval decision. 

Section 364 of the draft Energy and Commerce UFA bill would amend the FDC Act to add new § 505(w) (“Deadline For Determination On Certain Petitions”), which would state: “The Secretary shall issue a final, substantive determination on a petition submitted pursuant to [21 C.F.R. § 314.161(b)] (or any successor regulations), no later than 270 days after the date the petition is submitted” (emphasis added).  The amendment would apply to any withdrawal petition submitted to FDA on or after the date of enactment of the UFA bill. 

Both of the citizen petition provisions in the draft Energy and Commerce UFA bill seem to have come out of the blue.  The section-by-section backgrounder to the draft bill says that proposed FDC Act § 505(w) “should result in the quicker approval of generic drugs.”  That raises the possibility that inclusion of at least that section may be intended as an offset for other provisions in the bill.