04 April 2019 House Energy and Commerce Committee marks up drug pricing and ACA bills On April 3, 2019, the (Committee) held a markup on six drug pricing bills and six bills to bolster the Affordable Care Act (ACA) and lower health care costs. All six drug pricing bills advanced to the full House after the adoption of several amendments aimed at mitigating frivolous lawsuits and curbing deals that may improve market competition, pushed by Republicans on the committee. The committee also advanced to the floor six measures to bolster the ACA, all of which passed along party lines. The amended version of the CREATES Act (H.R. 956) — which would penalize branded drugmakers that withhold samples from generic drugmakers by citing safety concerns — would limit civil suits brought against branded drugmakers when they offer sufficient samples to generics at reasonable prices. It does not, however, include a provision sought by Republicans to limit the penalty measure to profits earned during a given period for a drug as opposed to revenue. Amended H.R. 149 — which would ban branded drugmakers from striking "pay-for-delay" deals with generic rivals to keep their products off the market — would only apply to agreements on or after the bill passes and would not apply to agreements retroactively. It would also allow the Federal Trade Commission (FTC) to exempt deals from penalties if it concludes they improve market competition and benefit consumers. The committee also approved H.R. 938, which would limit first-approved generic makers' ability to delay other rivals; H.R. 1520 and H.R. 1503, which would provide generic and biosimilar makers more information through FDA databases about the patents on branded products; and H.R. 1781, which would boost congressional advisory committees' access to pricing and rebate data. While the Senate version of CREATES (S. 34) does not include the new House provisions, Senate co-sponsor Chuck Grassley (R-IA) applauded the Committee's work to pass the bill in addition to the bill banning pay-for-delay agreements. Neither of the Senate versions has gone to the floor nor has the Senate version of the effort to give congressional advisory committees access to pricing and rebate data. The Committee also advanced six bills to reverse ACA "sabotage" by the Trump administration and other bills aimed at lowering health care costs for consumers. This included H.R. 1385, which would provide $200 million annually for state-based ACA marketplaces; H.R. 1386, which would provide $100 million to the federal navigator program; H.R. 1425, which would provide $10 billion annually to states for reinsurance or financial assistance programs; H.R. 1010, which would reverse the Administration's expansion of short-term health plans; H.R. 986, which would require the Administration to rescind its 1332 waiver guidance, which expands state flexibility to offer non-ACA-compliant plans; and H.R. 987, which would restore ACA outreach and enrollment funding cut by the Administration while restricting the funds from going to marketing for short-term plans. For more information, see the attached Tax Alert or visit the mark-up landing page. All approved amendments are attached.
Document ID: 2019-0697 | |||||
