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WASHINGTON -- The House Oversight Committee introduced three important pieces of legislation Thursday to address problems in how drugs are priced and come to market. These bills follow a comprehensive report by the committee based on multiple oversight hearings.
The Discounted Drugs for Clinical Trials Act (introduced by Chairwoman Carolyn B. Maloney and Rep. Peter Welch) amends the Federal Food, Drug, and Cosmetic Act to allow eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to manufacture. This bill aims to make pharmaceutical research less expensive and promote innovation by preventing high prices from impeding potential competitors’ clinical trials.
The Pharmaceutical Research and Transparency Act of 2022 (Chairwoman Carolyn B. Maloney with Rep. Jan Schakowsky) amends the Public Health Service Act and the Security Exchange Act to increase public transparency into the costs of clinical trials and overall R&D expenditures. The legislation would provide valuable data on companies’ investments in innovation and enable evaluation of pharmaceutical industry claims about research and development.
The Generic Substitution Non-Interference Act (Chairwoman Carolyn B. Maloney with Rep. David Cicilline) aims to block an anticompetitive practice called “Dispense-As-Written” campaigns. Some brand-name pharmaceutical companies use this tactic to suppress the uptake of lower-cost generic or biologic drugs, and leads to increased health care spending. The bill makes practices illegal that encourage health care providers to write “dispense as written” when a generic or biosimilar is available.
In response to the introduction of the bills, Patricia Kelmar, U.S. PIRG health care campaigns director, released this statement:
“Competition from lower-priced generic medicines that offer patients the same therapeutic treatment forces drugmakers to bring down their brand-name prices. Unfortunately, that trend has slowed because of too many barriers to competition in the pharmaceutical industry. Chairwoman Maloney and the House Oversight Committee did an excellent job of identifying ways our current system stifles a competitive market. This package of three important bills will increase cost transparency for innovation, increase access to brand medications for generic competitors to develop lower cost alternatives, and support patients' access to generic and biosimilar drugs at the pharmacy.
“Drug prices have been increasing year over year. These bills are a vital start to pulling down the obstacles to competition and bringing about needed reforms. Americans deserve greater transparency and improved access to lower-cost medications.”
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