Generic Drug Regulations and Health Insurance Marketplaces – Passage

Passage of the bill, as amended, that comprises a package of measures related to the development and market entry of generic drugs and a package of measures related to enrollment in and federal funding to support Affordable Care Act health insurance marketplaces. Title I of the bill includes provisions intended to facilitate the development and market entry of generic and biosimilar drug products. Specifically, it would allow the Food and Drug Administration to approve a subsequent company's application to manufacture a generic drug in cases where an initial company has applied but not received final FDA approval to introduce the drug after 30 months; approval of the subsequent application would trigger a 180-day exclusivity period for sale of the generic drug by the initial applicant company, after which point other generic versions could enter the market. It would prohibit generic and brand-name drug manufacturers from entering into agreements in which brand-name manufacturers pay to delay entry of a generic drug into the market, and it would authorize the Federal Trade Commission to issue penalties and initiate civil actions to enforce the prohibition. It would allow generic drug manufacturers to bring civil action against the license holder for a brand-name drug if the license holder does not provide "sufficient quantities" of samples of the brand-name drug on "commercially reasonable, market-based terms;" it would also outline certain affirmative legal defenses for defendants and certain terms for legal remedies in the case of a successful suit. Title II of the bill includes several provisions intended to facilitate enrollment in and provide funding and support for state- and federally-operated health insurance marketplaces under the Affordable Care Act. Specifically, it would authorize $200 million in grant funding for states to establish and operate state-based ACA health insurance marketplaces. It would authorize $100 million for Health and Human Services Department consumer outreach and educational activities related to ACA marketplace plans. It would authorize $100 million for the HHS "navigator" program, which funds certified entities to help individuals enroll in qualified plans, and would make certain modifications to the duties and selection of navigators. It would prohibit the HHS, Treasury, and Labor departments from taking any action to implement or enforce an August 2018 rule that effectively extends the maximum duration of coverage for short-term, limited-duration health insurance plans, which are not required to meet ACA patient protection requirements. As amended, the bill would authorize $25 million annually in grant funding for the ACA navigator program in state-based marketplaces and include a number of additional requirements related to outreach and education programs by navigators and by HHS.