What BIO says about tariffs

ORPHAN Cures Act included in House proposed reconciliation package

The House Energy & Commerce (E&C) Committee released its section of a reconciliation bill yesterday with encouraging proposals, including language from the ORPHAN Cures Act.

Mark-up is scheduled tomorrow in an E&C full-comittee hearing. The proposal includes:

• ORPHAN Cures Act language, to correct portions of the Inflation Reduction Act that disincentivize drugs for rare disease development.
• Pharmacy Benefit Manager (PBM) reforms proposed in the last Congress, to provide more transparency to drug middlemen who drive up drug prices and “delink” PBM’s compensation from a drug’s list price.
• Accelerating Kids Access to Care Act language, to facilitate out-of-state care for children needing specialized treatment.

BIO on tariffs: There are better ways to strengthen U.S. biotech

Tariffs on pharmaceuticals would threaten America’s security, economy, biotech leadership, and access to drugs, BIO explains in comments to the Department of Commerce.

To boost biopharma in the U.S., we need a global supply chain involving trusted trading partners and incentives for biotech development, BIO says in official input for the Commerce Department’s investigation into the feasibility of tariffs on pharmaceuticals.

The challenge with reshoring: While BIO supports more U.S. pharma production—the stated goal of proposed tariffs—reshoring will take years, cost billions, and cannot be done immediately.

“Nearly two-thirds of U.S. pharmaceutical consumption is manufactured domestically,” says BIO. But the complex supply chain still necessitates global trade with allies.

Tariffs threaten U.S. biotech leadership and patient access to drugs and would weaken biosecurity, BIO explains. A 25% tariff would add $50 billion or more in costs for the industry, devastating innovation. Patients would be cut off from drugs they need, and fewer new treatments would be developed.

To grow U.S. biotech, BIO recommends:

• Support the domestic manufacturing and services ecosystem.
• Reinforce and expand global trade cooperation.
• Develop the workforce.
• Expedite regulatory pathways.
• Improve access to capital.
• Develop regional manufacturing hubs.
• Encourage strategic technology leadership.

The bottom line: “The U.S. biotechnology sector depends on a highly complex, interdependent global supply chain,” says BIO. “Disruptions at any point, whether logistical, regulatory, or geopolitical, can jeopardize patient access to life-saving therapies and undermine the innovation ecosystem that drives the sector.”

Read more on Bio.News.

BIO members develop FDA-approved CRISPR pig, DNA data storage

The Food and Drug Administration (FDA) approved a member’s gene-edited, disease-resistant pig, while another member is revolutionizing data storage with DNA technology.

The pig: On April 29, the FDA approved a CRISPR-enhanced pig, developed by Genus subsidiary PIC, that is resistant to Porcine Reproductive and Respiratory Syndrome (PRRS). 

Why it matters: PRRS caused $1.2 billion annually in lost production in the U.S. pork industry from 2016 to 2020. It also encourages bacterial co-infection, driving up the use of antibiotics in the food chain, which can foster antimicrobial resistance. (Read more on Bio.News.)
 
The DNA storage technology: Twist Bioscience is spinning out its DNA data storage technology as an independent company, Atlas Data Storage, to focus on an innovation “with the potential to have an incredible impact on the world.”

How it works: By replacing the two numbers of binary coding with four letters, DNA can be 100,000 times more dense than the current media used to store data, experts say.

What BIO’s doing: Last week, BIO’s Beth Ellikidis spoke at at SynBioBeta’s Global Synthetic Biology Conference in San Jose about the future of the U.S. bioeconomy (below far left).

What Else to Read This Week

All eyes on MFN pricing: The industry has been anticipating President Trump signing an Executive Order this morning on a dangerous “most favored nation” pricing rule. Members of the Council of State Bioscience Associations (CSBA) sent a letter to congressional leaders opposing the flawed and damaging proposal and stressing the devastating consequences price controls in the U.S. will have on patient access, America’s biotechnology leadership, and our economic and national security. BIO is preparing its reaction and we will have more coverage on this tomorrow. Read the CSBA letter.

Trump signs Executive Order to ease reshoring of pharmaceutical manufacturing. The order directs the FDA to reduce approval time for new drug manufacturing facilities “by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with domestic manufacturers to provide early support before facilities come online.” Read the White House Fact Sheet.

Bristol Myers Squibb will spend $40 billion in the U.S. in the next five years, investing in R&D, domestic manufacturing, and technology. They join several BIO member companies highlighting U.S. investments as the Trump Administration calls for more U.S. pharma manufacturing. 

BIO President & CEO John F. Crowley joins TD Securities Biotech Decoded podcast. He covers industry challenges, conversations with the White House on tariffs, and more. Regarding tariff negotiations, he said: “Since we're aligned on the common goal of re-domiciling manufacturing in the United States, and so much of it is already happening, I think hopefully we'll be in a good place. I think we've got a month or two of work ahead of us with a number of the different policy makers, lawmakers, but they're really engaged in the discussions.” 

Crowley also hit the road across the Mid-Atlantic last week, stopping at Certara’s “Certainty” conference on Wednesday in Philadelphia, where he discussed his family’s personal journey and his policy priorities. Thursday, he headed to Delaware, where he moderated a one-on-one conversation with Joris Silon, AstraZeneca’s U.S. Country President, Biopharmaceuticals Business Unit (below). Their conversation covered everything from AstraZeneca’s business outlook and culture, to the growth of biotech in the First State, to the latest policy proposals affecting the industry in Washington, DC.

BIO’s Michele Oshman highlights the need for U.S. leadership on rare disease: “Time is of the essence to address the consequences created by the IRA’s misguided orphan drug policy, and to reauthorize the Rare Pediatric Priority Review Voucher program,” she said in her keynote at last month’s World Orphan Drug Congress. On the American Brain Coalition (ABC) “Voices for the Brain” podcast this week, she discussed the promise of biotechnology, ABC’s engagement on PPRV reauthorization, and the unique role multistakeholder coalitions like the ABC play in shaping policy, breaking down silos, and providing a unified voice for patients across many communities.

Patient advocates lead letter from 272 groups urging reinstatement of the recently eliminated Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC): “Our nation’s newborn screening system detects life-threatening diseases in newborn babies before they can cause irreversible damage or death,” enabling effective early treatment, says the May 5 letter to Health and Human Services Secretary Robert F. Kennedy Jr. “ACHDNC is a critical part of the U.S. newborn screening system, providing guidance … on the most appropriate application of universal newborn screening tests, technologies, policies, guidelines, and standards.” Read more.

Nkarta CEO Paul Hastings discusses the environment for biotech funding. The previous BIO Board Chair spoke during an Endpoints panel about the impact of regulatory uncertainty and federal funding cuts on the investment climate for biotechnology and the ability to launch new companies and deliver transformative medications to patients. Read more in Bio.News.

Merck Animal health announces $895 billion expansion in Kansas. Merck Animal Health and Kansas Gov. Laura Kelly on Thursday announced an $895 million expansion of Merck Animal Health’s manufacturing facility in De Soto, Kansas. The expansion will be built on an existing Merck-owned property that is the site of its biologics facility in De Soto, Kansas. Read more here.

Beltway Report

Health and Human Services (HHS) Secretary Robert Kennedy Jr. will testify twice on Wednesday on the HHS budget, before the House Appropriations Committee in the morning and the Senate Health, Education, Labor and Pensions Committee in the afternoon.