Health Law Daily Wrap Up, PHARMACEUTICAL NEWS—Senate panel advances six bipartisan bills to reduce prices, encourage competition in prescription drug market, (Apr 7, 2025)

By Cheryl Beise, J.D.

One bill, the Affordable Prescriptions for Patients Act, would place a limit on the number of patents a branded manufacturer can contest to curb “patent thickets,” which delay entry of less expensive biosimilar products.

The Senate Judiciary Committee during an Executive Business Meeting yesterday voted to advance out of committee six bipartisan bills aimed at reducing prescription drug prices for consumers and enhancing competition by eliminating abusive pharmaceutical industry practices. All six measures passed by voice vote, with only two receiving one nay vote. The lawmakers generally voiced support for the measures, emphasizing that consumers expect lawmakers to reduce prescription drug prices. Senator Grassley (R-Iowa) said the bills are intended to remove barriers to the entry of generic drug products to reduce consumer prices. Several similar pieces of legislation were introduced and approved by the Senate Judiciary Committee in the last Congress.

S. 527, Prescription Pricing for the People Act of 2025 (Grassley, Welch, Coons, Tillis, Blumenthal, Hirono). Purpose: to 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. S.527 would require the Federal Trade Commission (FTC) to complete a study examining the effects of consolidation on pricing in the Pharmacy Benefit Manager (PBM) industry, as well as other potentially abusive behavior by PBMs. The bill instructs the FTC to provide policy recommendations to Congress to improve competition and protect consumers. A summary of the legislation can be found here.

S. 1040, Drug Competition Enhancement Act (Cornyn, Blumenthal, Grassley, Durbin). Purpose: to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. An amendment by Senator Lee was approved by voice vote. Senator Blackburn was the only nay vote. S. 1040 would prohibit branded drug manufacturers from engaging in anticompetitive product hopping, making it an antitrust violation. Companies engaging in this behavior would risk enforcement action from the FTC. The bill would also facilitate market entry for generics and biosimilars, which drives down drug costs for patients and consumers.

S. 1041, Affordable Prescriptions for Patients Act (Cornyn, Blumenthal, Grassley, Durbin). Purpose: to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. S. 1041 would place a limit on the number of patents a manufacturer can contest, thus aiming to prevent a “patent thicket.” According to a Judiciary Committee news release, this bill is intended to help deter manufacturers from gaming the system, while preserving incentives to encourage the original innovation. Congress, in 2010, passed a law amending the Public Health Service Act, which was designed to quickly resolve any patent litigation before a biosimilar is introduced into the market. The law, found at 42 USC 262(i), creates a patent dispute resolution process commonly referred to as the “patent dance.” Acts of infringement covered by the Public Health Service Act include any patent that claims (a) the biological product, (b) any method of using the biological product, or (c) any method or product used to manufacture the biological product. The holder of a patent on a reference product (the reference product sponsor), under the Act would be limited to asserting no more than 20 patents. Of these, no more than 10 can have been issued after the date on which the reference product sponsor provides its list of its patents for which it believes an infringement claim might reasonably be asserted.

S. 1095, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act (Klobuchar, Grassley, Durbin, Blumenthal, Cruz, Welch, Booker). Purpose: to enable the Federal Trade Commission 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. S. 1095 would deter branded pharmaceutical companies from filing sham “citizen petitions” with the FDA in order to interfere with the approval of generic and biosimilar medicines that compete with their own brand products.

Two amendments proposed by Senator Lee failed on a roll call vote of 3-19. One amendment would have struck the bill’s presumption that any series of citizen petitions to the FDA that are referred to the FTC by the Secretary of the Department of Health & Human Services (HHS) are sham petitions filed to delay market approval of generics. The other amendment proposed to cap civil penalties under the law by net profits from the sale of a drug referenced in sham petitions, rather than revenues from the sales. Senator Lee was the only senator to vote against the measure.

S. 1096, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar, Grassley, Durbin, Blumenthal, Welch, Booker). Purpose: to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. This bill aims to reduce drug prices by promoting competition and taking on pharmaceutical manufacturer abuses of deals with competitors and FDA petitions. The measure would limit anticompetitive “pay-for-delay” deals that prevent or delay the introduction of affordable generic drugs that are, on average, 80 percent cheaper than their branded counterparts.

S. 1097, Interagency Patent Coordination and Improvement Act of 2025 (Durbin, Tillis, Grassley, Coons, Welch). Purpose: to amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office (USPTO) and the FDA for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. The bill would establish a task force to ensure the agencies are sharing information and have visibility into the work, trends, and specific data that the other agency may be engaged in; establish clearer rules of the road between the USPTO and the FDA; and provide greater clarity and information for all stakeholders, while ensuring that confidential information is protected.

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