SBIR and STTR are set to expire in September 2025 so congress must pass legislation to extend the SBIR & STTR programs. These programs are critical in supporting our emerging growth companies and allowing vital innovations to become commercialized enhancing the United States future competitiveness.

The OBBBA repealed the provision that R&D expenses could no longer be deducted in the same taxable year but rather businesses had to amortize such deductions over five years for domestic expenditures and 15 years for foreign expenditures. This previous legislation severely impacted early-stage companies from not being allowed to deduct R&D expenses in the year incurred. The OBBBA now allows for the immediate deduction of research and development costs.

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a. This recommendation of adopting foreign price controls would jeopardize patient access to innovative medicines. The absence of price controls in the U.S. leads to more and newer medicines made available sooner to Americans, with better health outcomes for those with serious diseases.

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This bipartisan bill addresses the harmful" pill penalty” created by the Inflation Reduction Act (IRA). This legislation seeks to correct a provision of the law the disincentivizes the development of small molecule drugs—essential treatments for conditions like heart disease, cancer and mental health disorders. Small molecules account for more than 90% of all prescriptions and two-thirds of new drug approvals yearly.

This proposal would reduce funding for the National Institutes of Health (NIH), undermining the agency’s ability to support groundbreaking biomedical research and innovation. These cuts would severely impact early-stage research efforts, limit opportunities for scientific discovery, and jeopardize the development of new treatments and cures. A reduction in NIH funding threatens the long-term health of our innovation ecosystem and the public health advancements that rely on sustained federal investment.

The OBBBA provided amendments to the Inflation Reduction Act aimed at boosting rare disease drug development to ensure that patients have access to innovative therapies. The OBBBA substantially broadens the scope of the Orphan Drug Exclusion.

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Continue to fund the tech hubs program supporting the United States national and economic security through regional tech hubs including the WI Biohealth Tech Hub.

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Reauthorize the Rare Pediatric Disease (RPD) Prior Review Voucher (PRV) program that has been effective in stimulating drug development to help address the unmet medical needs that exist in the pediatric rare disease community.

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These bills, if enacted, would strike at the heart of America’s medical innovation sector by undermining the IP infrastructure that drives it. The Biosimilar Red Tape Elimination Act would irresponsibly deem all biosimilars as interchangeable with their reference products without the necessary evaluation by the Food and Drug Administration (FDA). Medication Affordability & Patent Integrity Act imposes burdensome new reporting requirements on biopharmaceutical companies, ostensibly to prevent the U.S. Patent and Trademark Office (USPTO) from issuing patents for "inherent" aspects of drugs.

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This bipartisan legislation has now been introduced in both houses of Congress and provides for Medicare coverage of breakthrough technologies to which so many patients are in need of access. The FDA’s Breakthrough Devices Program is intended to provide patients and health care providers with timely access to emerging medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA invites med tech innovators to seek the designation if their device meets the criteria. The accepted devices will receive prioritized FDA review. As of Sept.30, 2024, 1,029 devices have received the designation, and 124 devices have received marketing authorization.

BioForward once again supports restoring the longstanding deduction for R&D expenditures which was changed in 2022 to a mandatory five-year amortization for domestic R&D. This greatly impacts emerging growth companies that depend on expensing the R&D expenditure in the year incurred. (H.R.2673 S.866)

Update: The House Ways & Means Committee approved the Small Business Jobs Act (H.R. 3937), which includes language to delay retroactively through 2025 the mandatory capitalization of R&D expenses.

BioForward appreciates Senator Tammy Baldwin for co-sponsoring S.866. BioForward appreciates Representative Glenn Grothman (WI-06) for co-sponsoring H.R. 2673.

• Act Now to Restore Immediate R&D Expensing & Protect Our Innovation Economy (bio.org)