BIO's Vice Chair testifies in busy week on the Hill

Onerous reporting requirements crushing small biotechs, BIO Board member testifies

Income reporting requirements are especially burdensome for biotechs funding research without revenue, and changes are needed to support innovation, a BIO Board member told Congress.

What happened: Frank Watanabe, CEO of Arcutis Biotherapeutics and Vice Chair of BIO’s Board, explained the unique position of biotechs in June 25 testimony before a House Financial Services Subcommittee on Capital Markets hearing.

Why it matters: Small biotechs go public to raise capital for R&D. But if their public valuation briefly crosses a threshold, they can be subject to Section 404(b) of the Sarbanes-Oxley Act, and suddenly be required to take on complex reporting requirements, often costing above $1 million.

The reality: “Since our inception, Arcutis has invested $1.4 billion in developing our products, and we generated no sales in our first six years of business,” Watanabe testified. “In our nine years of operation, we have not generated a single dollar of profit.”

Watanabe outlined solutions, including several ideas proposed in legislation discussed in the hearing:

• Expanding Section 404(b) exemptions for small businesses.
• Amending Section 404(b) exemption for low-revenue companies, adjusting the public float threshold from $700 million to $900 million.
• “Soft triggers” for public float and revenue thresholds: Only subjecting companies to Section 404(b) if they exceed the threshold over an extended period, such as 12 months.
• Revising “accelerated filer” and “large accelerated filer” definitions by raising the public float threshold to $900 million.
• Updating the Emerging Growth Company (EGC) designation, so companies can retain EGC exemptions for up to 10 years.

Read more on Bio.News.

ACIP approves flu vaccines and RSV treatment—and stirs concerns

The new Advisory Committee on Immunization Practices (ACIP) recommended flu vaccines and a respiratory syncytial virus (RSV) treatment last week but stirred concerns with questions about childhood immunizations and other accepted science.

Catch up: Health and Human Services Secretary Robert F. Kennedy Jr. on June 11 replaced all members of ACIP, which recommends Centers for Disease Control and Prevention (CDC) policy on immunization. Some new appointees have questioned long-standing, clear scientific evidence on vaccine safety.

Decisions: At their June 25-26 meeting ACIP voted to recommend:

• Flu vaccines for everyone six months and older.
• Merck’s Clesrovimab, a recently approved monoclonal antibody to protect infants from RSV.
• That flu vaccines containing thimerosal should not be used—though the ingredient is proven safe.

Criticism came from the American Academy of Pediatrics, who will publish their own vaccine recommendations after ACIP appeared “to sow distrust in immunizations.” Other critics: the National Foundation for Infectious Diseases and National Association of Pediatric Nurse Practitioners.

BIO’s view: “We are encouraged by the committee’s recommendations for flu vaccines and RSV infant immunization,” a BIO statement said. “We also continue to be concerned about the rise of vaccine skepticism, the risk of reducing access and availability to vaccines for American families, and the re-examination of the long-trusted and safe childhood immunization schedule.”

What’s next: Without a CDC director to approve ACIP’s recommendations (see Beltway, below), Kennedy may need to give approval instead.

Lawmakers urge support for disease research in HHS budget hearing

Members of Congress urged federal support for research into rare diseases and Alzheimer’s, and spoke of the dangers of leaving children unvaccinated, during a June 24 hearing on the Fiscal Year 2026 Health and Human Services (HHS) budget.

Who, what, where: HHS Secretary Robert F. Kennedy Jr. testified before the House Energy & Commerce’s Health Subcommittee.

On PPRV: Rep. Gus Bilirakis (R-FL) lauded inclusion of funding for the Pediatric Priority Review Voucher (PPRV) program, which incentivizes development of rare disease drugs for children, in next year’s Food and Drug Administration (FDA) budget. Rep. Bilirakis plugged his legislation to reauthorize the PPRV for several years.

On ORPHAN Cures: Secretary Kennedy backed Rep. John Joyce, M.D.’s (R-PA) ORPHAN Cures Act to address Inflation Reduction Act (IRA) disincentives against using rare disease drugs for multiple indications. Rep. Joyce cited a report showing a near-50% drop in the development of orphan drugs receiving multiple designations following the enactment of the IRA.

On Alzheimer’s research cuts: Rep. Nanette Barragán (D-CA) said the budget would cut $1.7 billion for the National Institute on Aging’s Alzheimer's Disease Research Centers. She said 13 of 35 centers were closed in May and urged funding for the rest.

On preventable diseases, Rep. Kim Schrier, M.D. (D-WA) recalled treating children suffering from measles, bacterial meningitis, and pertussis, noting that vaccines can prevent such suffering. “Vaccines only work if you give them,” she said.

What Else to Read

Did you know Alzheimer’s impacts 7 million Americans? During June’s Alzheimer’s Awareness Month, Bio.News spoke with the Alzheimer’s Association to explore three facts about who is impacted by dementia, the importance of early detection, and more.

BIO 2025: The innovation race vs. the regulatory pace. While exciting jumps in technology and innovation improve and save lives, regulation must keep pace. To ensure that pace can be maintained, regulators like the Food and Drug Administration (FDA) need to collaborate with industry and advocacy partners to stay educated, said experts on the final day of the 2025 BIO International Convention in Boston. Read more on Bio.News.

Beltway Report

On June 26, Reps. Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus to advance bipartisan policy solutions to keep the United States at the forefront of global biotechnology leadership, to engage and learn from sector leaders, and to build awareness and bioliteracy among Members of Congress. “The bipartisan BIOTech Caucus will play a pivotal role in creating the policy and regulatory environment needed to leverage our scientific ingenuity and innovative spirit to advance U.S. leadership in biotechnology. We look forward to working closely with the BIOTech Caucus and its members to address these vital issues,” said Kelly Seagraves, BIO’s VP of National Security and International Affairs, quoted in the press release.

On June 25, Susan Monarez expressed support for vaccination and no bias against mRNA vaccines during a Senate Health, Education, Labor, and Pensions Committee hearing on her nomination for Director of the Centers for Disease Control and Prevention (CDC). Concerns about the full replacement of the Advisory Committee on Immunization Practices (ACIP) in mid-June were raised by a bipartisan group of Senators. Monarez said the ACIP board was replaced to instill public confidence and agreed ACIP members should go through ethics screening. Responding to Ranking Member Bernie Sanders (I-VT) she said there is no causal link between vaccines and autism. Responding to Sen. Roger Marshall, M.D. (R-KS), Monarez said it is essential to invest in the next generation of antibiotics to prevent a catastrophe from antimicrobial resistance.

Congress is continuing to work through the One Big Beautiful Bill Act.