Bills encourage generic drug competition and require FTC study on PBMs

On April 30, the House Judiciary Committee approved by voice vote four bipartisan bills aimed at boosting generic drug competition, tamping down on anti-competitive practices, and promoting transparency into the pharmaceutical supply chain. The CREATES Act (H.R. 965), which penalizes drugmakers that withhold samples from generic rivals, was approved after passing through the Energy and Commerce Committee earlier this month and could now move to the House floor for a vote. The committee also approved H.R. 2375, a measure to ban so-called “pay-for-delay” agreements, but is different from another pay-for-delay bill (H.R. 1499) passed through Energy and Commerce and more closely resembles the enforcement and safe harbor protections found in a Senate bill co-sponsored by Sens. Amy Klobuchar (D-MN) and Chuck Grassley (R-IA). H.R. 2375, along with two other bills that advanced — the STALLING Act (H.R. 2374), aimed at curbing abuse of the FDA's petition process to block generics, and H.R. 2376, which would require the Federal Trade Commission (FTC) to study whether pharmacy benefit managers (PBMs) have been anticompetitive — may continue on to Energy and Commerce Committee for approval before potentially advancing to the full House. Details on the advanced bill found here:

• H.R. 965, the “CREATES Act”: Sponsored by Rep. David Cicilline (D-RI), H.R. 965 would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
• H.R. 2374, the “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act": Sponsored by Rep. Hakeem Jeffries (D-NY), H.R. 2374 would enable the Federal Trade Commission (FTC) to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes.
• H.R. 2376, the “Prescription Pricing for People Act of 2019”: Sponsored by Rep. Doug Collins (R-GA), H.R. 2376 would require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes.
• H.R. 2375, the “Preserve Access to Affordable Generics and Biosimilars Act”: Sponsored by Rep. Jerry Nadler, H.R. 2375 would prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

Addtional information is available here.

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