Bill to Stop Disingenuous Citizen Petitions Advances in House

November 15, 2019
Allison Inserro

A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.

A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.

The bipartisan bill, HR 2387, the Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019, was introduced last spring by Representatives Andy Levin, D-Michigan, and Francis Rooney, R-Florida.

Citizen petitions are an avenue for any interested party to ask the FDA commissioner to change agency regulations or take—or refrain from taking—an administrative action. In the case of drug makers, such requests may include asking the FDA not to approve a generic or biosimilar product unless certain conditions are met.

Citizen petitions have nonetheless been the subject of controversy, as they require significant time and resources for the FDA to address. Among many stakeholders, there exists a consensus that brand-name drug makers could (and sometimes do) use these petitions to forestall competition from generic or biosimilar drugs.

In September, the FDA released final guidance to determine if citizen petitions are abusive.

If the bill becomes law, it would codify the FDA’s intent. It would allow the FDA to quickly reject a citizen petition submitted with the aim to stall a generic drug’s approval. It directs the HHS secretary to report such citizen petitions to the Federal Trade Commission and requires drug manufacturers to file a petition within 60 days of receiving actionable information. The bill also directs the FDA to report additional information to Congress, including: time and resources spent on each petition; timing of petitions relative to patent expiration; and any delay in approval of a competing generic drug caused by such petition.

America’s Health Insurance Plans (AHIP) submitted testimony on behalf of its member payer organizations, saying that while the FDA’s “petition process provides an opportunity to raise legitimate concerns about the safety and effectiveness of new drugs, it has also been exploited to delay or prevent the availability of more affordable generic drugs and biosimilars. This legislation takes important steps to curb abuses in the citizen petition process and remove barriers to the generic drugs that Americans need and deserve.”

Supporters of the bill say certain drug makers have abused the petition process to slow approvals and maintain monopolies.

However, on the other side of Congress this week, a bill called the Affordable Prescriptions for Patients Act did not advance, with Senator John Cornyn, R-Texas, accusing Senate Minority Leader Chuck Schumer, D-New York, of blocking the bill.

Cornyn and Senator Richard Blumenthal, D-Connecticut, introduced the bill, which aims to prevent patent thickets and product hopping, last spring. It has since gained other sponsors.

Schumer said the bill does not go far enough, according to a report, which also said that Schumer noted that Senate Majority Leader Mitch McConnell, R-Kentucky, had not scheduled any votes on any bills aimed at drug prices.

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