Yesterday, 4 senators introduced a bill on the Senate floor that would allow HHS to block drug price increases that it deems as “excessive.”
Yesterday, Senators Richard Blumenthal, D-Connecticut, Kamala Harris, D-California, Amy Klobuchar, D-Minnesota, and Jeff Merkley, D-Oregon, introduced a bill on the Senate floor, S. 3754, that would allow HHS to block drug price increases that it deems as “excessive.”
The bill, dubbed “A bill to prohibit price gouging in the sale of drugs,” is just the latest in a series of actions that Congressmen and the government alike have taken to address high drug prices.
In May 2018, the Trump administration released the “American Patients First” blueprint which contained 4 main strategies for decreasing drug prices, including increased competition, better negotiation, incentives for lower list prices, and reducing out-of-pocket costs. Since the release of the blueprint, the FDA approved more generic drugs in July 2018 than in any single month in its history.
Additionally, in July 2018 the FDA also released its Biosimilar Action Plan. The plan sought to improve the efficiency of the biosimilar development and approval process and support market competition through the reduction of anti-competitive practices that unfairly delay market entry. In 2018 alone, the FDA has approved 6 biosimilars of rituximab, epoetin alfa, adalimumab, pegfilgrastim, and filgrastim.
The administration took further action in October 2018 when HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer television advertising.
The proposal was met with pushback from industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), when it announced that instead of including the list price within the advertisement, it would launch a “new platform that would provide patients, caregivers, and providers with cost and financial assistance information for brand-name medicines, as well as other patient support resources.” PhRMA also made clear to HHS that if such a requirement was made, it would raise significant legal questions, including First Amendment concerns.
Though 2018 has seen significant focus on reducing drug prices, more action is sure to come in 2019. According to Reuters, Democrat House of Representatives leader Nancy Pelosi, D-California, has promised to continue to work to tackle the issue of high drug prices when the newly-elected House is sworn in in January 2019.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.