Hello Rapid Response Subscriber,

This is week 3 of rapid response updates! As part of our effort to keep you in the loop, you’ll be getting a quick update from us each week covering both emerging policy issues impacting industry and responsive AdvaMed activity. 

We welcome your insights and questions on any of the topics included. Please don’t hesitate to reply directly or raise additional concerns through the submission portal on our Emerging Policy Response Center. We also encourage your feedback on this update’s format, level of detail, or anything else that can help us relay the information better.
 

Issue 1: Executive Order on Domestic Pharmaceutical Manufacturing Reform 

What’s Happening:

On May 5, 2025, President Trump signed an Executive Order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines”. The order aims to reduce regulatory burdens and accelerate domestic pharmaceutical manufacturing. The EO also calls for enhanced inspections of foreign pharmaceutical manufacturing facilities, which FDA announced on May 6, and for increased fees on foreign pharmaceutical manufacturing facilities. 

Why It Matters:

While targeted at the pharmaceutical industry, this EO could directly impact provisions negotiated as part of the current PDUFA, signaling the administration may be willing to disrupt current user fee agreements. . 

What’s Next & AdvaMed Action:

We are monitoring the implementation of the EO for any impacts it may have on MedTech. 

Issue 2: Supreme Court Review of Kennedy v. Braidwood Management, Inc.  

What’s Happening:

On April 21, 2025, the U.S. Supreme Court heard oral arguments in Kennedy v. Braidwood Management, Inc., a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) under the Affordable Care Act (ACA). The plaintiffs argue that the USPSTF's recommendations, which mandate insurance coverage for preventive services, are unconstitutional due to the Task Force's appointment process. Following the arguments, the Court ordered additional briefing to address whether the Secretary of Health and Human Services has the power to appoint USPSTF members, a central issue in the case. 

Why It Matters:

The court’s decision could affect coverage requirements for various medical services, diagnostics, and devices, potentially leading to structural changes in healthcare coverage. 

What’s Next & AdvaMed Action:

The Supreme Court is expected to issue its decision in the next few months. AdvaMed is closely monitoring the case and will update members once a decision is issued, including hosting a member webinar. 

Issue 3: Nairobi Protocol Webinar Recording Available 

What’s Happening:

This webinar will explore the Nairobi Protocol and its relevance to medical device manufacturers. 

Why It Matters:

Understanding this international trade agreement can help MedTech companies navigate tariffs, customs procedures, and better consider their approach to new tariffs on global markets. 

What’s Next & AdvaMed Action:

The recording is now available on demand here. 

Issue 4: Executive Orders on Federal Procurement Reform 

What’s Happening:

President Trump issued two Executive Orders aimed at overhauling the federal procurement process:

• Restoring Common Sense to Federal Procurement:
  Directs a major reform of the Federal Acquisition Regulation (FAR), eliminating non-essential provisions to improve efficiency, reduce costs, and promote usability. It includes a regulatory sunset clause for non-statutory rules, which will expire after four years unless renewed.
• Ensuring Commercial, Cost-Effective Solutions in Federal Contracts:
  Prioritizes the use of commercially available products and services in federal contracts to promote innovation and reduce reliance on costly, custom solutions.

Why It Matters:

These changes could lower barriers for MedTech companies seeking to do business with the federal government, opening more opportunities for commercial technologies and streamlining compliance burdens. 

What’s Next & AdvaMed Action:

AdvaMed continues to review the impact of these reforms and monitoring forthcoming implementation guidance from OMB and the FAR Council. We are also connecting with other interested coalitions to learn more and identify collaborative opportunities. Member feedback remains essential to help shape our strategy.
Share your insights: rapidresponse@advamed.org.

Issue 5: OMB Request for Information on Deregulation 

What’s Happening:

The Office of Management and Budget (OMB) has issued a Request for Information seeking public input on federal regulations that may be outdated, unnecessary, or overly burdensome. The initiative aims to identify opportunities for deregulation across various sectors.​ 

Why It Matters:

This RFI presents an opportunity for the MedTech industry to provide input.

What’s Next & AdvaMed Action:

AdvaMed requested member feedback from across our policy teams and divisions and is preparing comments in response to the RFI focused on deregulation for the benefit of innovation and patient care. Public comments are due May 12, 2025. 

Other RFIs/Comments We Are Tracking

The Department of Justice (DOJ) has launched an Anticompetitive Regulations Task Force and issued a Request for Information (Docket No. ATR-2025-0001), seeking public input on laws and regulations that may hinder competition. In addition, the DOJ and Federal Trade Commission (FTC) issued a joint letter directing federal agencies to identify regulations that reduce competition, entrepreneurship, and innovation. Comments are due by May 26. AdvaMed is drafting comments and will submit by the deadline.

The Centers for Medicare & Medicaid Services (CMS) has issued a Request for Information on Medicare Regulatory Relief, inviting input on policies that may create unnecessary burdens or limit access to care. The comment deadline is June 10. AdvaMed is preparing comments in consultation with working group members and internal teams.