To date, FDA has issued five draft guidance documents on its efforts to meet the goals outlined in FDA's GDUFA commitment letter.

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). FDA is seeking comments and will have a public hearing regarding three specific topics: (1) FDA's five recent draft guidance documents that relate to its implementation of GDUFA; (2) potential reforms to resolve issues relating to FDA's 180-day exclusivity determinations, including forfeiture determinations; and (3) FDA's procedures with respect to expedited ANDA review for a first generic company that files an application for which there are no blocking patents or exclusivities. The specifics of FDA's request for comment are discussed further below. The public hearing will be held on September 17, 2014, from 9 a.m. to 5 p.m. Electronic or written requests to make an oral presentation at the hearing must be submitted by September 3, 2014, and FDA will accept written comments until October 13, 2014.

GDUFA Draft Guidance Documents

To date, FDA has issued five draft guidance documents¹ on its efforts to meet the goals outlined in FDA's GDUFA commitment letter. FDA is seeking general comments on those guidance documents, but it is also requesting input on whether there are GDUFA-implementation issues that are related or unrelated to the guidance documents that were not addressed by those guidances. In addition, FDA is seeking comment on whether the industry would benefit from guidance on any other topics or issues relating to generic drug development other than GDUFA implementation.

GDUFA and the 180-day Exclusivity Period

A second aspect of the September hearing will be to discuss possible processes that FDA may utilize under GDUFA for making certain determinations regarding the 180-day exclusivity period that is awarded to the first generic Abbreviated New Drug Application (ANDA) filer for a product. Specifically, FDA is seeking comment on the following topics:

1. Public process for 180-day exclusivity determinations: Should FDA's consideration of eligibility for 180-day exclusivity, including whether the exclusivity has been forfeited, be a public process? If so, should the public process apply to all 180-day exclusivity considerations? What administrative mechanisms should be used for public processes?
2. Legal challenges to 180-day exclusivity determinations: What legal or regulatory mechanisms are available to better facilitate FDA's determination and resolution of any challenges to its 180-day exclusivity determinations?
3. Any other topics relating to 180-day exclusivity determinations that require comment.
4. Any topics relating to 180-day exclusivity determinations that would benefit from FDA guidance.

It is unknown how 180-day exclusivity determinations and forfeiture relate to or are a problem that should be addressed under GDUFA. That said, exclusivity determinations are a key issue to the generic drug industry. Concerned participants may want to take advantage of FDA's willingness to discuss and improve the issue.

GDUFA and Expedited Review for "First Generics"

The last topic for the September hearing relates to the reference in FDA's GDUFA commitment letter to ANDAs that may be submitted for expedited review, including ANDAs for "first generic products for which there are no blocking patents or exclusivities on the reference listed drug." FDA reiterated in its request that it will be prioritizing ANDA review consistent with the Manual of Policies and Procedures (MAPP) 5240.3 Rev. 1 and MAPP 5200.4, but asked for comment regarding the specific criteria that should be used for identifying an ANDA as a first generic eligible for expedited ANDA review. FDA also is seeking comment on any other topic involving expedited review.

Conclusion

Comments on any or all of the above issues can be submitted electronically at http://www.regulations.gov. FDA recommends early registration for those who intend on attending the hearing in person, and it has requested that individuals and organizations with common interests consolidate or coordinate their presentations and request time for a joint presentation.

For Further Information

If you have any questions about this Alert, please contact Kevin M. Nelson, Patrick C. Gallagher, Ph.D., any of the attorneys in our Intellectual Property: Generic and Biosimilar Pharmaceuticals Practice Group or the attorney in the firm with whom you are regularly in contact.

Note

1. ANDA Submissions—Content and Format of ANDAs; ANDA Submissions—Refuse to Receive for Lack of Proper Justification of Impurity Limits; ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA; ANDA Submissions—Prior Approval Supplements Under GDUFA; and Controlled Correspondence Related to Generic Drug Development.

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