Regulatory Focus™ > News Articles > 2019 > 4 > DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics

DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics

Posted 01 April 2019 | By Zachary Brennan 

DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics

As part of a push to increase insulin competition and bring down the price of insulin, Rep. Diana DeGette (D-CO) and Tom Reed (R-NY) introduced a bill on Monday that aims to make certain US Food and Drug Administration (FDA) guidance into law.

The guidance in question explains how FDA plans to transfer drugs previously approved under new drug applications (NDAs), including insulins, to be biologic license applications (BLAs) next March as part of the Biologics Price Competition and Innovation Act, which also created the biosimilar approval pathway.

The so-called “Deemed to be a License” draft guidance makes clear that NDAs transitioning to BLAs will not gain an additional 12 years of exclusivity because of the switch.

“Nothing in the Biologics Price Competition and Innovation Act suggests that Congress intended for biological products approved under section 505 of the FD&C Act — some of which were approved decades ago — to obtain a 12-year period of reference product exclusivity upon being deemed to be licensed under section 351(a) of the PHS Act,” FDA says, explaining how the allowance of an additional 12-year period of reference product exclusivity “would inappropriately impede biosimilar or interchangeable product competition in several product classes.”

And the guidance is almost identical to what’s written in the bill.

The guidance says: “A biological product that was first approved in an NDA under section 505 of the FD&C Act and deemed ‘licensed’ under section 351(a) of the PHS Act on March 23, 2020, will not have been ‘first licensed under subsection (a)’ for purposes of section 351(k)(7) of the PHS Act. Thus, such a biological product will not be eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS Act.”

And the bill says: “An approved application that is deemed to be a license for a biological product under” Section 351(k)(7) of the Public Health Service Act “pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a).”

The need to codify the guidance comes as industry groups, such as PhRMA and BIO, as well as other biopharma companies, are raising questions and concerns with how FDA has interpreted the law in terms of reference product exclusivity.

On Tuesday, the House Energy & Commerce Committee Subcommittee on Oversight and Investigations will hold a hearing on the rising cost of insulin. The committee in January sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin.

Bill Text

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