“Deemed to be a License” Provision Poses Potential Issues for Biological Products

Regulatory Guidances  •  U.S. FDA News

The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”).  Section 7002(e) addresses the circumstances under which an application filed under section 505 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) can be deemed to be licensed under the Public Health Service Act (“PHS Act”). Under the FDA’s draft guidance, an application for a biological product filed under section 505 of the FD&C Act that is not approved by March 23, 2020, would not be approved under section 505. Moreover, the FDA would remove any product “deemed to have licenses” from the Orange Book on March 23, 2020, meaning that the FDA’s findings of safety and efficacy for such products could not be relied upon by a 505(b)(2) applicant for approval of a related product, even if that product is under active review as part of the NDA process.

On Monday, FDA Law blog posted on a recent response to the FDA’s request for comment in which Hyman, Phelps & McNamara, P.C. (HP&M), on behalf of their clients, highlighted the “unnecessarily restrictive proposal for handling biological products submitted under section 505 of the FD&C Act that have been submitted but not yet approved as of March 23, 2020.”

HP&M’s comment concluded that the FDA’s proposed interpretation “will impact a great number of ongoing development programs, causing irreparable financial harm to many sponsors, stifling innovation and availability of competition, and, putting countless patients at unnecessary risk.” They urge the FDA to use their “flexibility in the interpretation of the “deemed to be a license” provision of the BPCI Act” and in view of prior interpretations of the FD&C Act to support a reading of section 7002(e) that “would allow applications for biological products submitted under section 505 of the FD&C Act that are pending on March 23, 2020 to be reviewed and eligible for approval.”

 

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