As the industry heads to San Diego for BIO26 next week, plenty is happening back in Washington that will shape the ecosystem our members are building. A few things worth knowing before everyone’s wheels are up.
CMS Moves to Make Medicare Drug Price Negotiation Permanent: On June 12, CMS proposed a rule to convert the Medicare Drug Price Negotiation Program from program guidance into a permanent, codified regulatory framework, beginning with initial price applicability year 2029. The agency would select up to 20 additional Part B and Part D drugs for the fourth negotiation cycle, and the rule includes two items directly relevant to our members. First, it would implement the statutory Temporary Floor for Small Biotech Drugs, limiting how low CMS can counteroffer for eligible small-biotech products in 2029 and 2030. Second, it proposes a “narrow modification” to how CMS identifies qualifying single-source drugs to address program-integrity concerns posed by certain new formulations, which bears watching for any company whose lifecycle strategy involves reformulation. CMS frames the shift as moving “from annual updates to a permanent, predictable framework,” and notes the program has negotiated prices for 25 high-expenditure drugs in its first two years.
Bipartisan Bill Would Treat Biological Data as a Strategic National Resource: On June 16, Senators Todd Young, Alex Padilla, Mike Rounds, and Andy Kim introduced the Web of Biological Data Act, with a House companion led by Reps. Matt Van Epps and Massachusetts’ own Jake Auchincloss. The bill directs the Department of Energy to establish the Web of Biological Data (WOBD), which would serve as a single, secure point of entry for U.S. researchers to access high-quality, AI-ready biological datasets, beginning with a pilot at a DOE national lab within two years and a fully realized system within five. It reflects a core recommendation from the National Security Commission on Emerging Biotechnology, which Senator Young chairs: that the U.S. must manage biological data as a strategic national resource to retain biotech leadership. Rep. Auchincloss framed the stakes in research terms, noting that progress on complex diseases like Alzheimer’s and schizophrenia has lagged in part because researchers struggle to overlay genomic, biologic, and neurologic data. The bill preserves existing privacy protections and arrives with broad support.
Senate HELP Markup This Week: The Senate HELP Committee took up a slate of health bills, including one we have been watching closely, S. 2658, the Medication Affordability and Patent Integrity Act. The bill would require companies to certify that statements made to the FDA and USPTO are consistent and to send the patent office any information material to patentability that they submit to the FDA, which has raised real concerns about trade-secret exposure and added burden on an already-overstretched USPTO. The Bill advanced out of committee on a 16-6 vote, though its patent provisions will require coordination with the Senate Judiciary Committee so there remains a window to shape the text before it moves further. During the markup, Senator Sanders also introduced a most-favored-nation amendment that ultimately failed.
Court Upholds National-Security Bar on SBIR Award: A new decision from the U.S. Court of Federal Claims carries a sobering message for small companies competing for federal SBIR funding. In Kayhan Space Corp. v. United States, the court upheld the Air Force’s denial of an SBIR award to a Colorado space-software startup on national security grounds, holding that historical ties to a foreign country of concern can be sufficient to disqualify a company, even when those ties are decades old and were never concealed. The Air Force based its determination entirely on the fact that the company’s two co-founders, naturalized U.S. citizens who immigrated from Iran, had studied at a Tehran university the agency characterized as having ties to the Islamic Revolutionary Guard Corps, and that one founder had previously worked at an entity connected to a sanctioned Iranian bank. The case is an early test of the enhanced due-diligence regime Congress built to keep foreign adversaries out of the SBIR program, and the takeaways are pointed. SBIR and STTR dollars are a meaningful early-stage funding source for Massachusetts companies, and a non-trivial share of our researchers and founders carry exactly the kind of international academic and professional backgrounds this screening scrutinizes. This is something we will need to watch closely as agencies stand up implementation of the new SBIR rules following recent reauthorization, both for how broadly the “country of concern” screen is applied and for what it means for talented, U.S.-based scientists building companies here.
