FDA proposal would ‘name and shame’ companies delaying generics

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US October 12, 2018

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The FDA announced a draft guidance last week under which it would make public the names of pharmaceutical companies found to be unnecessarily delaying generic competition approvals. Companies also could be investigated by the Federal Trade Commission (FTC) under the proposal.

The proposed change involves citizen petitions and petitions for stay of action, through which companies can ask the FDA not to approve a product—or to pull its approval—for reasons related to science, regulation or public health.

The FDA has long said that many of these petitions are frivolous. The proposal would allow it to deny petitions that fail to raise valid scientific or regulatory issues. Notably, the FDA also would publish the names of companies whose petitions it denies in an annual report to Congress and would refer petitions it believes were submitted solely to delay or deny competition to the FTC for potential enforcement action.

HRI impact analysis

From 2008 to 2016, the FDA received 182 petitions; it granted eight in full, according to the agency. Of those remaining, 127 were denied; five were withdrawn; and 42 were partially denied. Some petitions have, for example, asked the FDA not to approve a generic that could be split in two when the original drug had been reformulated to be split into three parts, according to the AU Law Review. The FTC has sued some companies for their use of citizen petitions.

If the new policy is enacted, its impact might be limited. The outcomes of citizen petition proceedings already are public through the federal docket. Many companies enlist third parties, such as law firms, to file petitions on their behalf.

The issues that companies raise in citizen petitions often aren’t obviously frivolous and may therefore not be easy to dismiss. For example, a branded drug company may have reformulated its drug in response to public health concerns, so it may be reasonable to reject a generic that refers to the original formulation. Companies also may choose to file several citizen petitions—some companies may file dozens—in a bid to persuade the FDA to delay a drug’s approval pending the petitions’ resolution.

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Jason Ranville

Senior Manager, Health Research Institute, PwC US

Noah Marwil

Research Analyst—Health Research Institute, PwC US

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