Good Day BIO: SBIR passed, PDUFA moves forward

Ending the last week before the October recess with a busy day on Capitol Hill, with Congress passing SBIR/STTR yesterday and the continuing resolution with PDUFA expected to pass today. Also, we recap yesterday's Senate hearing on limiting sensitive foreign investment in research. (757 words, 3 minutes, 47 seconds)

For your weekend entertainment, remember to listen to the latest I am BIO podcast, "Data Storage Crisis: DNA to the Rescue," on Apple, Google, or Spotify. 

Federal funding: SBIR program approved, Senate OKs PDUFA deal

Yesterday Congress approved the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) and the Senate forwarded the Prescription Drug User Fee Agreement (PDUFA) to the House, setting both up for reauthorization before today’s deadline.

The FDA user fee agreements, including PDUFA, were bundled with the stopgap spending measure that passed the Senate yesterday and is expected to pass the House today. (See an itemized summary.)

The “clean” FDA user fee bill had no riders attached, so it keeps the FDA operating but sets up continued discussion about specific programs, including the Accelerated Approval pathway, according to reports. “There is more work ahead this Congress,” Senate HELP Committee leaders said.

Accelerated Approval allows market entry for medications that address critical illnesses with no therapies. It has facilitated hundreds of drugs for HIV/AIDS, cancer, and rare diseases, permitting treatments that save money and lives. There have been proposals to limit the pathway and BIO has opposed them.

SBIR preserved:SBIR/STTR programs were funded in a separate bill, with the House approving legislation extending the program three years yesterday by a vote of 415-9. The bill had been held up due to Senate concerns that China would benefit from the research, but it passed with the additional stipulation of background checks to screen foreign involvement, Axios reports. It now goes to the President's desk for his signature.

Many BIO members are startups and small businesses who have used SBIR/STTR early-stage funding to get potentially life-saving ideas from the lab to the market.

BIO actively supported SBIR with more than 450 letters sent to Members of Congress during a recent BIO Action campaign to advocate for reauthorization, and pushed for action on Capitol Hill.


More Health Care News:

The Washington Post: FDA approves first ALS drug in 5 years after pleas from patients
“In 2014, the organization raised $115 million in six weeks from the Ice Bucket Challenge and provided $2.2 million of that to help pay for testing AMX0035, the drug’s name during development. The medication is the first funded by the organization to receive FDA approval. Amylyx has agreed to use proceeds from sales of the medication to repay the organization 150 percent of its investment.”

Bill would limit U.S. investment in foreign research

U.S. investment in sensitive, cutting-edge research abroad would be more tightly controlled under a proposal discussed in the Senate yesterday.

The legislation: The proposed “National Critical National Critical Capabilities Defense Act" (S. 1854 and H.R. 6329), which has bipartisan support, would establish a new Committee on National Critical Capabilities to review, and potentially prohibit, investments in certain “critical capabilities” in “countries of concern.” The Senate Banking, Housing, and Urban Affairs Committee held a hearing on the bill yesterday.

Warning of “the threat of forced technology transfers,” Sen. John Cornyn (R-TX), a co-author of the legislation, told the hearing China has successfully built on foreign investment, which now funds developments in areas like semiconductors and artificial intelligence.

A bipartisan group of lawmakers wrote the Biden Administration on Tuesday requesting an executive order to increase oversight of foreign investment while they negotiate proper legislation, Reuters reported. “When we cede our manufacturing power and technological know-how to foreign adversaries, we are hurting our economy, our global competitiveness, American workers, industry and national security,” they wrote.

Counseling caution, Committee Ranking Member Pat Toomey (R-PA) told the hearing limits on foreign investment could discourage companies from setting up in the United States. Hearing witness Thomas Feddo, a former U.S. Treasury official, agreed that despite a “real and present” threat from China, any legislation should “avoid creating unnecessary burdens on U.S. persons’ business transactions.”

It’s important to keep biotech investment in the U.S. BIO President and CEO Dr. Michelle McMurry-Heath has promoted the importance of measures to facilitate biomanufacturing in the United States. President Biden drove the cause forward with his executive order on biomanufacturing earlier this month.

More Agriculture and Environment News:

EPA: EPA Administrator Regan launches new national office dedicated to advancing environmental justice and civil rights
“EPA’s historic Office of Environmental Justice and External Civil Rights will position the agency to better advance environmental justice, enforce civil rights laws in overburdened communities, and deliver new grants and technical assistance.” 

President Biden’s Friday: Attending the investiture ceremony for Associate Supreme Court Justice Ketanji Brown Jackson before speaking about Hurricane Ian. This afternoon, the White House will host receptions to mark the Jewish New Year and Hispanic Heritage Month.

What’s Happening on Capitol Hill: It’s a big day. As noted, the Senate passed the Continuing Resolution (which includes PDUFA) to fund the government until December 16; the House is expected to pass the bill today, averting a government shutdown tonight. The House and Senate are still expected to be in recess for most of October ahead of the midterm elections.

Meanwhile, yesterday, BIO co-hosted a reception during the Congressional Black Caucus Annual Legislative Conference—watch highlights of remarks by BIO President and CEO Dr. Michelle McMurry-Heath and U.S. Rep. Bobby Scott (D-VA)