Why we need new antifungals – fast

We’re gearing up for another busy week in Washington—but first, what USTR said about biotech corn on Friday and why we need to act on a rapidly spreading fungus. (450 words, 2 minutes, 15 seconds)

Why we need new antifungals – fast

Candida auris (C. auris) “spread at an alarming rate in U.S. healthcare facilities in 2020-2021,” reported the Centers for Disease Control and Prevention (CDC) last week—yet another sign that we need new antimicrobials and antifungals, fast.

What’s happening: The number of drug-resistant C. auris cases tripled in 2021, from 476 in 2019 to 1,471 in 2021—with 17 states identifying their first case ever during the time frame, says the CDC.

Why it matters:C. auris is “often resistant to multiple antifungal drugs, spreads easily in healthcare facilities, and can cause severe infections with high death rates,” explains the CDC.

The big picture: The World Health Organization (WHO) last year released the first-ever fungal priority pathogens list, with 19 fungi posing “the greatest threat to public health.”

Luckily, the FDA just approved a new antifungal: REZZAYO, the first new drug for candidemia and invasive candidiasis in over a decade. The drug was developed by Cidara Therapeutics and will be commercialized by BIO member Melinta Therapeutics.

But we need more: “a robust pipeline of new antimicrobial medicines,” says BIO’s AMR expert Emily Wheeler. In the U.S., policy solutions like the PASTEUR Act and antimicrobial reimbursement reform could help address the unique challenges of the antimicrobial marketplace. Earlier this month, BIO joined over 230 organizations representing health care providers, public health professionals, patient groups, and the pharmaceutical and diagnostics industries in a letter urging Congressional leadership to include PASTEUR in any moving legislative vehicle in 2023, including the reauthorization of PAHPA—learn more.

On biotech corn, USTR commits to using ‘all of the tools in the USMCA’

After appearing before the Senate Finance Committee Thursday, U.S. Trade Rep. Ambassador Katherine Tai discussed the administration’s trade policy agenda again at the House Ways and Means Committee Friday, where there was bipartisan concern about biotech corn.

Catch up: The U.S. Trade Representative formally requested technical consultations on Mexico’s biotech corn ban under the U.S.-Mexico-Canada Agreement (USMCA). Canada followed with its concerns.

From a Republican: “Mexico must uphold its USMCA obligations,” said Ways and Means Chairman Jason Smith (R-MO). “Effective enforcement is required to protect American workers and farmers. What next steps will the administration take to ensure Mexico upholds its USCMA obligations?"

From a Democrat: “The USMCA dispute with Mexico is significant,” echoed Rep. Mike Thompson (D-CA). “My district is home to a growing biotech industry. What is the administration's effort to hold Mexico accountable in the GMO corn case, and what other opportunities exist for biotech?"

USTR’s response: “All of the tools in the USMCA are there for a reason, and we stand ready to make use of those tools to help us to resolve this issue,” said Ambassador Tai.

President Biden’s Monday: Hosting the Small Business Administration’s Women’s Business Summit.

What’s Happening on Capitol Hill: Another busy week on Capitol Hill will bring testimony from Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Xavier Becerra, plus a hearing on transparency in healthcare costs (tomorrow) and a hearing on pharmacy benefit managers (Thursday).