GDUFA Implementation and Hatch-Waxman Kim Dettelbach (Senior Counsel, FDA’s Office of Chief Counsel) Dave Read (Acting Deputy Director, Office of Generic Drug Policy, OGD/CDER) September 18, 2012 What can FDA do? What can Industry do? There is little obvious connection between the text of the GDUFA commitments and 505(j), i.e., that part of Hatch-Waxman most relevant to generic drugs. With one exception, the GDUFA implementing statute did not change H-W in any way.* And the GDUFA Commitment Letter really only adds one new category of expedited ANDA that arguably is related to H-W. *The period to obtain TA without forfeiting 180-day exclusivity was extended to 40 months for ANDAs filed between 1/9/10 and 7/9/12. The Commitment Letter Pursuant to the CL, FDA has three obligations regarding review prioritization that touch on Hatch-Waxman: #1: Expedite year 1 + 2 FTF PIV ANDAs. #2: Expedite all FTF PIV ANDAs within 30 months of submission to avoid forfeiture. • The above obligations overlap and are familiar. Prior to GDUFA, OGD worked hard to make sure FTFs don’t “slip through the cracks.” #3: Expedite at submission and over the course of review ANDAs that are/become eligible for approval as a result of no blocking exclusivities, patents and/or applicable stays. • The italicized portion is new. It usually concerns a subsequent applicant that becomes eligible for approval based on a change with respect to the FTF PIV ANDA. What can FDA do? What can Industry do? Areas for Discussion • Forfeitures of 180-day exclusivity • Premature Paragraph IV notifications and similar practices • FDA’s use of dockets for Hatch-Waxman issues • When to bring in the Office of Chief Counsel; and when not to Forfeitures of 180-day Exclusivity (6 events) • Failure to obtain a tentative approval within 30 months • Failure to market within a specified time after approval • Expiration of all patents with which exclusivity is associated • Withdrawal of the ANDA • Amendment of all paragraph IV certifications • Entering into an agreement that is in violation of antitrust laws as determined by FTC Forfeiture (cont.) Agency has no influence with respect to 5 of these 6 events. Failure to obtain TA within 30 months is the forfeiture event of prime concern to industry. The Agency is very aware of its role in getting ANDAs tentatively approved and is taking steps to minimize forfeitures on this basis GDUFA Commitment Letter goals are about actions, not approvals and tentative approvals. However, the CL does state that: “FDA will strive to review and act on all ANDAs that are submitted on the first day that any valid Paragraph IV application for the drug in question is submitted within 30 months of submission to avoid causing first applicants to inadvertently forfeit 180-day exclusivity eligibility…” Forfeiture (cont.) Our Mutual Goal – the Agency, like industry, wants as few “failure to obtain TA” forfeitures as possible The Agency is doing its part by adding review resources and expertise at every level to ensure applications are taken up and reviewed more quickly and complete responses (or approvals or tentative approvals) are given on a 10 month clock Industry must do its part by submitting higher quality applications, taking advantage of Agency resources available for presubmission consultation when appropriate, and following advice that FDA provides We expect forfeitures under this prong to decrease under GDUFA. DTR3 Even under the best of circumstances, occasional forfeitures are inevitable DTR1 making forfeiture Query: Is the current process for the agency decisions satisfactory? Slide 7 DTR1 At this point I'll give a farly detailed description of the current process. DTR3 Some breif discussion of why this is a more complex question than it first appears. Read, David T, 9/12/2014 Read, David T, 9/12/2014 Premature Paragraph IV notifications and similar H-W practices We understand that that the generics market is very competitive and companies look for ways to make the system work for them; however, certain “clever” strategies such as the following are counterproductive and divert resources from review of applications – Premature paragraph IV notification (sent before the agency has sent a letter officially acknowledging the ANDA as received) • Contrary to both the statute and the regulations (despite strained arguments to the contrary) • A source of considerable confusion since notice kicks off time to bring lawsuits; diverts review and other resources – Abuse of NCE-1 process – Untimely notification of litigation status; delay of notice until after someone else’s suit has been resolved – Untimely notification of launch triggering 180-day exclusivity. FDA’s use of dockets for Deciding Hatch-Waxman issues • File 505(q) petition for issue falling within scope of 505(q) • For issues of general or widespread interest that we discover or that are brought to our attention, we will sometimes open a public docket • Mixed message from industry – We are sometimes asked to use this method more often DTR2 – Others object to this process • This process is public, transparent, and leads to wellconsidered decisions with input from interested parties Slide 9 DTR2 It is somehwta resource intensive, but has the significant benefit of creating both an opportunity for public comment and an AR of the final decision. Read, David T, 9/12/2014 When to bring in the Office of Chief Counsel. . . and when not to • On any given day, there are thousands of ANDAs pending before the agency. • It is therefore a “big ask” to request that OCC turns its attention to one of these for more routine matters • In general, you should not approach OCC unless there is a significant legal issue or an issue that you believe has been resolved incorrectly • BUT if you believe we have made an error or are about to make an error and/or are contemplating suit, we want to hear from you • If you do approach OCC, come prepared!
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