S. 1095 — Stop STALLING Act

This section establishes Federal Trade Commission (FTC) liability under section 5(a)(1) of the FTC Act (15 U.S.C. 45(a)(1)) for any person submitting or causing submission of a sham covered petition—or series of covered petitions—relating to FDA approval of new drug applications, abbreviated new drug applications, or biologics license applications. (A covered petition is a petition or supplement under section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)); a sham petition is objectively baseless and filed primarily to use the governmental process, rather than its outcome, to interfere with a competitor's business; and a series involves more than one such petition on the same application. As background, section 505(q) petitions allow third parties to raise safety, efficacy, or other concerns that may delay FDA approval of competing drugs.) The section authorizes the FTC to commence civil actions in federal district court to recover civil penalties and other relief, with a rebuttable presumption of sham if the Secretary of Health and Human Services refers a determination that the petition's primary purpose was delay (including a reasoned basis) and it was part of a series. Civil penalties equal the greater of (1) the person's revenue from the drug referenced in the petition during the FDA review period or (2) $50,000 for each calendar day each sham petition was under review. The section applies to covered petitions submitted on or after enactment; states that FTC and HHS referrals are not judicially reviewable except as third-party claims; and clarifies that it supplements, rather than limits, existing FTC and antitrust authorities (as defined in 15 U.S.C. 12(a)).

This section establishes Federal Trade Commission (FTC) liability under section 5(a)(1) of the FTC Act (15 U.S.C. 45(a)(1)) for any person submitting or causing submission of a sham covered petition—or series of covered petitions—relating to FDA approval of new drug applications, abbreviated new drug applications, or biologics license applications. (A covered petition is a petition or supplement under section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)); a sham petition is objectively baseless and filed primarily to use the governmental process, rather than its outcome, to interfere with a competitor's business; and a series involves more than one such petition on the same application. As background, section 505(q) petitions allow third parties to raise safety, efficacy, or other concerns that may delay FDA approval of competing drugs.) The section authorizes the FTC to commence civil actions in federal district court to recover civil penalties and other relief, with a rebuttable presumption of sham if the Secretary of Health and Human Services refers a determination that the petition's primary purpose was delay (including a reasoned basis) and it was part of a series. Civil penalties equal the greater of (1) the person's revenue from the drug referenced in the petition during the FDA review period or (2) $50,000 for each calendar day each sham petition was under review. The section applies to covered petitions submitted on or after enactment; states that FTC and HHS referrals are not judicially reviewable except as third-party claims; and clarifies that it supplements, rather than limits, existing FTC and antitrust authorities (as defined in 15 U.S.C. 12(a)).

This section establishes a severability clause, providing that if any provision of the Act, or its application to any person or circumstance, is held unconstitutional, the remainder of the Act and its application to any person or circumstance shall not be affected.

This section establishes a severability clause, providing that if any provision of the Act, or its application to any person or circumstance, is held unconstitutional, the remainder of the Act and its application to any person or circumstance shall not be affected.