EO on drug pricing, outlook for pharma tariffs, and more

A busy April is flying by. Today, we look at the executive order on drug pricing, the threat of pharmaceutical tariffs, a CDC meeting on immunization practices, and BIO’s appearances at many conferences across the U.S. (750 words, 3 minutes, 45 seconds)

Executive Order on drug pricing includes actions to remove barriers to innovation

The Trump Administration’s Executive Order on drug pricing included numerous directives, including some that may be challenging for biotech and some that address key barriers to innovation.

BIO is still analyzing the potential impact. While there are welcome policies “that will help strengthen American innovation and lead to lower prescription drug costs for patients,” we recognize that not everything in the EO will have a positive effect on the biotechnology industry.

BIO’s initial comments:

Pill penalty: “By calling for a fix to the ‘pill penalty’ (which gives small molecules less price control protections than biologics), the president’s Executive Order takes an important step towards addressing a critical flaw in the Inflation Reduction Act.”

Pharmacy benefit managers and hospitals: “The Executive Order will also help address abuses by middlemen and large hospitals that are driving up the cost of medicines for everyone. We are hopeful this is the first step to simplify the system and address policies that hinder biotech innovation and undermine access to medicines for American patients and families.”

Work to do: BIO will continue to work with lawmakers to implement policies that lower cost for patients and remove barriers that adversely impact our innovation ecosystem.

Commerce Dept. investigation lays ground for pharma tariffs

The U.S. Department of Commerce issued a public notice announcing a “232 investigation” that is a precursor to expected tariffs on pharmaceuticals.

What it is: The investigation, under Section 232 of the Trade Expansion Act, is meant to determine the effects of pharmaceuticals and pharmaceutical ingredients on U.S. national security, according to the announcement.

Why it matters: President Trump said tariffs would encourage more drug manufacturing in the U.S. Last year’s BIO member survey found that reshoring or “friend-shoring” manufacturing could take eight years. BIO’s survey last month showed tariffs would threaten our national security, harm investment, cause disruption in our supply chains, and reduce patient access to medicine.

The impact: 94% of biotech firms anticipate surging manufacturing costs from tariffs on the EU, while tariffs on Canada and China would have a similar impact. “More than 50% of biotech firms predict ‘increased difficulty’ in funding and conducting research if EU tariffs are enacted,” the survey found.

BIO’s recommendations to secure the U.S. supply chain and ensure America remains the global leader in medical innovation:

• Expedite regulatory pathways to accelerate the approval of life-saving treatments.
• Strengthen capital formation to fuel the next generation of biotech breakthroughs.
• Protect and advance strong IP rights, the foundation of America’s innovation.

BIO’s view: “Re-onshoring key parts of the biotechnology supply chain to the U.S. and our allies and strengthening the American manufacturing base should be a high priority for both national and economic security. It will take years, though, for this shift and we need to be mindful of the negative consequences of these proposed tariffs,” according to BIO President & CEO John F. Crowley.

What Else to Read This Week

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met and issued several recommendations, including recommending the use of approved respiratory syncytial virus (RSV) vaccines for adults as young as 50 who are at increased risk of RSV. Last year, the CDC recommended vaccines for adults 60 and older who are at increased risk of RSV. ACIP's recommendations become final when approved by the CDC director. In their absence, another senior CDC leader may be designated to approve the recommendations.

Reminder: Hemophilia affects women and girls, too. This year’s theme for World Hemophilia Day (April 17)—“Access for all: Women and girls bleed too”—focuses on the fact that this population is often underdiagnosed and underserved. Read more from the National Bleeding Disorders Foundation on Bio.News.

World Orphan Drug Congress in Boston features broad BIO participation. Michele Oshman, BIO Chief Patient Advocate & Head, Patient Advocacy Center of Excellence, will give the keynote on Wednesday and speak on a panel on Thursday about storytelling in rare disease. E’Lissa Flores, Director, Science & Regulatory Affairs, will speak on a panel on rare disease R&D, and Melody Calkins, Director, Healthcare Policy, will join discussions on pricing and reimbursement

World Vaccine Congress in D.C. highlights BIO expertise. Praneel Jadav, BIO Manager, Infectious Disease Policy, will moderate two panels: “Rapid vaccine development through manufacturing innovation” and “What do the next 4 years hold? Policy landscape for 2025 and beyond.” The World Vaccine Congress has grown to become the largest vaccine meeting of its kind, with last year’s event having a record 4000+ attendees. 

While gene editing holds great promise for helping animals withstand disease, regulatory burdens and barriers to commercialization keep us from realizing its full potential, said BIO experts at the Animal Agtech Innovation Summit in Dallas, April 8-9. Mark Walton, BIO Senior Director, Regulatory Affairs, joined a panel, “Precision Livestock Genetics: Commercializing Biotech Innovations to Advance Healthier, More Sustainable, and Productive Livestock.” Walton and Sylvia Wulf (pictured), BIO’s Interim Head of Agriculture and Environment, also hosted a roundtable entitled “Animal Biotechnology: Building Industry Acceptance.” Read more on Bio.News.

Beltway Report

The House and Senate are not in session this week.