What BIO's watching in Congress

Beginning a new week with a look at BIO’s congressional priorities for 2024—and how you can take action on some of them—as well as progress on Biden’s bioeconomy executive order. (544 words, 2 minutes, 43 seconds)

What BIO’s watching in Congress this year

As the 118th Congress begins its second year, we spoke to BIO about the top priorities for the industry and patients in 2024. 

R&D amortization: As of 2022, R&D expenses must be amortized over five years, reducing the full deduction to 20% annually. With remedial legislation moving through Congress, BIO launched a campaign to urge policymakers to reverse the change—click here to take action.

PBM reform: Acting as middlemen between drug makers, pharmacies, and insurers, pharmacy benefit managers exploit their market power to profit by driving up drug prices. Congress advanced PBM reform last year, with the House passing the Lower Cost, More Transparency Act by a bipartisan vote in December. (BIO’s taking action on PBMs, too.)

A few more priorities at the federal level include…

• The Inflation Reduction Act’s impact on orphan and small molecule drugs. The law disincentivizes the development of orphan drugs for rare diseases and small molecule drugs. The ORPHAN Cures Act, making its way through Congress, would exempt orphan drugs from price controls even if they’re approved for multiple indications.
• The Pandemic and All Hazards Preparedness Act, which awaits reauthorization, will help us get ready for the next pandemic.
• The Farm Bill, which was renewed for one year but awaits the full five-year reauthorization, can support much-needed agricultural biotech and biomanufacturing.
• Antimicrobial resistance: The PASTEUR Act would address market problems to encourage the development of antimicrobials.
• The Rare Pediatric Disease Priority Review Voucher Program needs funding to incentivize the development of novel therapies to treat pediatric diseases and spur investment to help the most vulnerable. 

Read more in Bio.News.

Biden’s Bioeconomy Executive Order, year-one review

In the first year of President Biden’s Bioeconomy Executive Order (EO), federal agencies produced key strategy documents and tools, but tough work is ahead, a tracking report finds.

A whole-government approach: The EO involves several agencies in promoting the $950 billion U.S. bioeconomy. It requires coordinated federal R&D funding, streamlined regulation, stronger data-based research, more opportunities for bioenergy and biobased products, and support for education.

What’s been done: According to the Federation of American Scientists (FAS), key documents have been produced thus far, including:

• Bold Goals for U.S. Biotechnology and Biomanufacturing by the Office of Science and Technology Policy, which envisions the EO’s potential.
• The Coordinated Framework for the Regulation of Biotechnology by the U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA), which outlines a comprehensive U.S. regulatory policy for ensuring safety of biotech products.

What’s missing: Foundational elements that should have been put in place earlier, including consensus on how to measure the size of the bioeconomy, as well as a coordinating body to oversee and unite federal agencies’ diverse efforts.

What’s next: The tracking report is a living document. FAS will monitor the progress of the EO and continue to update the document.

President Biden’s Monday: No official events scheduled.

What’s Happening on Capitol Hill: We’re keeping an eye on the tax package that includes the restoration of the R&D tax deduction; the House could take it up this week. (Click here to urge your lawmaker to vote for it.) On Wednesday, Melanie Egorin, Assistant Secretary for Legislation at the Department of Health and Human Services (HHS), is scheduled to testify in a House Oversight Committee in a hearing on HHS compliance with Congress.