Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more
On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”) brought by Republican Attorneys General and the Trump Administration. ...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
This week in Washington: The House and Senate will be in recess the week of Feb. 17 in observation of Presidents Day....more
On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
On February 26, 2019, the Senate Finance Committee heard testimony from top executives representing seven high-profile drug manufacturers. This hearing was the second to examine drug pricing in America. The Committee’s...more
Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on eliminating so-called “gag clauses” that prevent pharmacists from telling patients...more
Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and...more
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
The Medicare program is once again looking to reduce payments to 340B hospitals for Part B drugs and biologicals. As part of its proposed payment regulation for hospitals under the Outpatient Prospective Payment System (OPPS)...more
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more
Outlook for This Week in the Nation's Capital - Minibus on Senate Floor. The Senate is expected to take up a four-bill spending package next week. ...more
LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more
Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices. The HHS blueprint to lower drug prices includes improving competition by...more
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more
On May 11, President Trump delivered remarks about his administration’s new plan to help lower drug prices. The President blamed “soaring drug prices” on “everyone involved in the broken system,” including “the drug makers,...more
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more