With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
On February 13, 2025, shortly after Robert F. Kennedy, Jr., was confirmed by the U.S. Senate as secretary of Health and Human Services, President Donald Trump issued an executive order establishing the Make America Healthy...more
On January 31, 2025, President Trump signed Executive Order 14192 which is formally titled, “Unleashing Prosperity Through Deregulation,” but could gain notoriety as the “10 for 1 Order.” The Order has several parallels to a...more
Of the scores of day-one executive orders (EOs) issued by President Trump, the order rescinding a Biden administration executive order on lowering prescription drug costs is receiving much attention, given implications the...more
On February 2, 2024, a bipartisan group of six U.S. senators released much-anticipated draft legislation to reform the Health Resources and Services Administration’s (HRSA) 340B drug discount program. Known as the SUSTAIN...more
As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more
With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more
The Senate Finance Committee’s release of a draft bill focused on addressing youth and adolescent mental and behavioral health challenges marks the latest positive indicator of bipartisan interest in enacting legislation to...more
Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more
On Monday, July 27, Senate Republicans released a series of bills to embody the latest COVID-19 relief package. Proposing several separate bills at once gives the Senate the option of passing provisions that enjoy broader...more
7/29/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Economic Injury Disaster Loans ,
Financial Stimulus ,
Health Care Providers ,
Paycheck Protection Program (PPP) ,
Relief Measures ,
Telehealth ,
Unemployment Insurance ,
Virus Testing
The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more
On Friday, May 11, 2018, President Trump delivered a highly anticipated speech addressing high drug prices and unveiling his administration’s blueprint to lower drug prices and reduce out-of-pocket costs. American Patients...more