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The Federal Trade Commission has responded to the Food and Drug Administration’s request for comment on its revised draft guidance, which aims to deter pharmaceutical companies from abusing the citizen petition process to delay approval of and competition from generic drugs.

According to the comment, many have expressed concerns about the gaming of citizen petitions. Although some citizen petitions raise genuine issues for scientific consideration, many do not, and are denied as lacking merit. Answering a petition requires significant FDA resources and time, including careful consideration of the issues by appropriate FDA staff, and preparation, review, and vetting of the response across the FDA.

In its revised draft guidance, the FDA describes considerations it will use to determine whether a petition was submitted primarily to delay approval of a competing drug. Once the FDA determines that a petition was submitted primarily to delay competition, it will refer that determination to the FTC, according to the guidance.

The FTC has investigated complaints of citizen petition abuse as potential violations of federal antitrust law, the comment states. In 2017, the agency filed a complaint in federal district court charging that branded pharmaceutical company Shire ViroPharma illegally maintained its monopoly power by abusing government processes, including the citizen petition process.

The FTC shares the FDA’s concerns about patient access to lower-cost generic drugs and supports the FDA’s efforts to deter abuse of the citizen petition process, according to the comment. Additionally, as the FTC’s comment makes clear, the agency stands ready to work closely with the FDA on citizen petition abuse and other issues that may harm competition and lead to higher prescription drug costs.

The Commission vote approving the statement was 5-0. (FTC File No. PO13510; the staff contact is the staff contact is June Im, Bureau of Competition, 202-326-2279.)

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Contact Information

Betsy Lordan
Office of Public Affairs