Can we save the horseshoe crab?

We’re back—and so’s the Senate. Here’s all the news you missed last week plus the launch of the new season of the I am BIO Podcast. (646 words, 3 minutes, 13 seconds)

HHS names first drugs facing price controls

Following the Biden administration’s announcement of the first ten drugs to be subjected to price controls, BIO criticized the harm already being done to innovation.

While we were on break: U.S. Health and Human Services (HHS) announced it will force drug makers to “negotiate” prices for ten drugs, and BIO responded.

What’s next: The Centers for Medicare & Medicaid Services’ timeline for the price-setting process includes forced “negotiations” in 2023-24, with new prices published in one year and taking effect in 2026. Every year, more drugs will be up for price controls under the Inflation Reduction Act (IRA).

The impact: “The Medicare price control provisions of the IRA are already significantly, and negatively, impacting the research and investment decisions of the biotech industry in the U.S.,” says Rachel King, BIO Interim President and CEO. “The IRA impacts not just the drugs targeted on today’s list, but the entirety of the biotech ecosystem that must make research and funding decisions many years in advance.”

BIO’s next steps: “BIO and our members will continue our efforts to thwart the overtly negative impact the IRA’s price control provisions will have on patient access, innovation, and economic development,” says King.

I am BIO Podcast: How biotech can help horseshoe crabs

The copper-based blue blood of horseshoe crabs is used to test for endotoxins in injectable pharmaceuticals before entering the market. Biotech firms want to help preserve the crabs with a synthetic substitute, explores today’s season opener of the I am BIO Podcast.

Why it matters: After surviving five mass extinctions over nearly half a billion years, horseshoe crabs are endangered in Asia and “vulnerable” in the United States—and an estimated 30% of crabs captured for blood harvesting die. Meanwhile, the red knot, a threatened shorebird, needs the crab’s eggs.

A solution: Recombinant factor C (rFC) works at least as well as horseshoe crab blood, provides supply chain certainty, and costs less. Eli Lilly is a leader in industry efforts to encourage regulations making rFC use standard practice.

What they’re saying: Horseshoe crab blood is “a finite natural resource,” says Jay Bolden, the birder and quality control specialist leading Lilly’s efforts.

But we need to standardize regulations. The U.S. Pharmacopeia (USP) will consider eliminating regulatory hurdles to using rFC for toxin testing, Bio.News reports. USP announced it will accept public comments on rFC during November-January.

Listen: The new episode of the I am BIO Podcast also features science writer Deborah Cramer and Genentech’s Lindsey Silva. Listen at www.bio.org/podcast or your favorite podcast app.

ICYMI: FTC ends lawsuit BIO called harmful to innovation

The Federal Trade Commission (FTC) settled a lawsuit that BIO’s amicus brief warned would “chill investment, with predictable and unwelcome results for innovation and drug development.”

ICYMI: The FTC sued to block Amgen from acquiring Horizon Therapeutics; both companies are BIO members. Last week, Amgen announced the settlement, saying it “will have no impact on Amgen’s business.”

BIO filed an amicus brief on Aug. 24 arguing FTC’s unusual overreach created market uncertainty, casting doubt on the biotech dealmaking essential to developing lifesaving innovations.

The importance of M&A: “Mergers and acquisitions help define much of the biopharmaceutical innovation ecosystem,” said BIO. FTC has traditionally recognized that mergers increase competition, and changing this approach would harm investment, the brief said.

More Health News:

Rockland/Westchester Journal News: Pfizer’s women leaders talk representation, mentoring, and vaccine hesitancy
“Pfizer’s research team at their Rockland campus now has all-female leadership — five top scientists at the world-renown research site are women. As such, they are in charge of innovating new approaches to vaccines amid growing vaccine hesitation, emerging infectious diseases and recirculating viruses once considered tamed.” 

President Biden’s Tuesday: Presenting the Medal of Honor to Army Capt. Larry L. Taylor for “conspicuous gallantry” in protecting U.S. troops in Vietnam, according to UPI.

What’s Happening on Capitol Hill: The Senate is back to work and is expected to vote on Phillip Jefferson’s nomination for the Federal Reserve this week. The House returns next week.