News & Analysis as of

Trump Administration Biosimilars Prescription Drugs

Morrison & Foerster LLP

Trump Antitrust Enforcers Take Aim at High Drug Costs, With Uncertain Path Forward

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

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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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

Goodwin

President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs

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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

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

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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

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

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

Patterson Belknap Webb & Tyler LLP

Bill Requiring Disclosure of Biosimilar Settlement Agreements to the FTC and DOJ Becomes Law

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

Goodwin

President Signs Bill Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

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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

Mintz - Health Care Viewpoints

Significant Drug Pricing Developments in July – Here’s What You Need To Know

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

Clark Hill PLC

Window On Washington - Vol. 2, Issue 29

Clark Hill PLC on

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

BakerHostetler

Capitol Hill Healthcare Update

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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

Goodwin

HHS Seeks Public Comments on Trump Administration’s Plan to Lower Drug Prices

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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

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

• 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

Goodwin

President Trump’s Remarks on Lowering Drug Prices; Industry Reactions

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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

Hogan Lovells

Administration presents plans to lower drug prices

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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

Holland & Knight LLP

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

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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

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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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

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