BIO joins amicus brief against mifepristone ruling

The response to Friday’s mifepristone ruling continues, as BIO joined an amicus brief calling for suspension of the ruling and explains in STAT News how it’s just the latest assault on FDA’s authority. In better news, partnering ahead of the BIO International Convention is moving at a record pace—we have details. (581 words, 2 minutes, 54 seconds)

BIO joins amicus brief against mifepristone ruling

BIO yesterday signed on to an amicus brief calling for the suspension of a federal District Court ruling that undercuts the FDA’s authority to bring treatments and cures to patients. 

Why it matters: By circumventing a “longstanding statutory and regulatory framework,” the amicus brief warns, Friday’s ruling to block Food and Drug Administration (FDA) approval of mifepristone “would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development.”

BIO’s Executive Committee unanimously agreed to join about 125 other signatories to the amicus brief, filed in the U.S. Court of Appeals for the Fifth Circuit.

The brief argues:

• The court, which lacks scientific or medical expertise, undermines the FDA’s ability to act on behalf of patients.
• The ruling is an assault on the importance of comparative safety data and would inhibit FDA’s broad acceptance of new data.
• The decision would create new regulatory barriers regarding approved labeling.
• BIO supports a balance between agency regulatory flexibility and judicial checks, but the ruling’s unprecedented obstacles “could upend crucial investment, research, and development in the biomedical field.” 

BIO’s take: “We will continue to organize and mobilize America’s scientific community to challenge this unprecedented effort to undermine the FDA’s expertise and to ensure that patients have access to safe and effective medicines,” said BIO President and CEO Rachel King. 

What’s next: The Justice Department asked the Fifth Circuit Appeals Court to suspend the ruling by tomorrow while it is appealed, The Washington Post reported. Without a suspension, access to the drug would be blocked on Friday.

Watch what Rachel King says:

The big picture: The mifepristone ruling is “just the latest blow in an ongoing assault on the FDA’s authority,” write BIO’s Dr. Cartier Esham and John Murphy in STAT News. From the “assault on the FDA’s long-standing accelerated approval program” to the decision on coverage of a breakthrough Alzheimer’s drug to Friday’s ruling, the FDA “is being systematically undermined in its efforts to advance and protect public health.”

Read and share the whole thing.

Partnering activity moves at a record pace for BIO International Convention

The BIO International Convention partnering platform is filling up at a record pace, indicating robust networking and dealmaking ahead in June in Boston.

What’s the BIO International Convention? The world’s largest gathering of biotech and life sciences leaders brings together thousands of executives and investors to learn about industry developments and network. The Convention holds the world record for partnering and fostered 44,000 partnering meetings last year alone.

How’s this year shaping up? BIO’s One-on-One Partneringтм platform launched March 27 with more than 3,000 executives and business development leaders signing up in the first week, a 65% increase over the same period last year.

What’s the One-on-One platform? BIO’s unique platform allows participants to complete a profile with the type of partnerships they seek. The system finds matches and schedules times and locations for face-to-face meetings at the Convention site.

What’s new? Users can mark participants as optional so the scheduler won’t consider a whole team unavailable if one member is busy. “This will help get people more meetings, especially highly important meetings with large pharmas, whose teams often have full partnering schedules,” says Mackensie Vernetti, BIO’s Senior Director of Partnering. 

Learn more and register here.

President Biden's Wednesday: Celebrating and reaffirming the importance of the 25-year-old Good Friday peace accord in Northern Ireland as he begins a three-day trip that will include recognition of his family's Irish heritage, per The Washington Post.

What's Happening on Capitol Hill: Recess.