Patrick Cooney for AMRC
June 24, 2025
FEDERAL AGENCY NEWS
FDA Announces Expedited Review for Drug Application Submissions
On June 17, 2025, the U.S. Food and Drug Administration announced a new National Priority Voucher (CNPV) program. Drug developers may redeem the new voucher to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
According to the FDA announcement, the new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system, where a drug application is sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
The FDA plans in the first year of the program to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. National health priority areas identified include:
- Addressing a health crisis in the U.S.
- Delivering more innovative cures for the American people.
- Addressing unmet public health needs.
- Increasing domestic drug manufacturing as a national security issue.
To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. Sponsors must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review.
FDA Announces Review of New Clinical Trials Involving Overseas Research
On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients. See link to announcement.
This action by the FDA follows mounting concern that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments, including adversaries.
The FDA announced it is actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.
CAPITOL HILL NEWS
Research and Development Tax Provision in Budget Reconciliation
The Senate returns this week with critical choices on Medicaid and tax policies that will chart a course for the next decade as part of the budget reconciliation process. Last month, the House passed its version of the One Big Beautiful Bill, which would help pay for President Trump’s tax cuts with reductions in federal spending on Medicaid. Last week, the Senate Finance Committee unveiled its version, which includes steeper Medicaid cuts.
One provision of note that could impact clinical research is expensing provisions for research and development. Under current law, companies conducting research in the U.S. must amortize their domestic research and experimental (R&E) expenses over five years (or 15 years for foreign R&D), rather than deducting the full amount in the year the costs are incurred. This change, enacted as part of the 2017 Tax Cuts and Jobs Act (TCJA) and effective beginning in tax year 2022, was designed to raise revenue on paper, but it created a significant cash flow burden for research-intensive businesses.
Both the House-passed H.R. 1 and the Senate Finance Committee’s budget reconciliation draft propose to reverse this rule and restore full, immediate expensing of domestic R&D costs. The House version would do so retroactively to 2022, allowing companies to amend prior returns and reclaim tax overpayments. The Senate version is more nuanced: it restores full expensing starting in 2025, but offers a “catch-up” option to accelerate amortized R&D deductions from prior years, and allows small businesses (with under $31 million in gross receipts) to retroactively expense R&D from 2022 onward. Both versions retain the 15-year amortization requirement for foreign research, reinforcing an incentive to conduct studies in the U.S.
The impact of restoring full R&D expensing on clinical research would be substantial. We are monitoring developments on this and will update if there are further changes.
