News: Califf wants adcomms revamped. Not everyone agrees.

Friday, May 10, 2024

Califf wants adcomms revamped. Not everyone agrees.

May 10, 2024

Driving The Day

Robert Califf speaks.

FDA Commissioner Robert Califf is pushing to reduce the number of votes taken by the agency's advisory committees. | Win McNamee/Getty Images

WHAT’S IN A VOTE? In recent days, FDA Commissioner Robert Califf has repeatedly made the case that conducting fewer advisory committee votes would result in more fulsome discussions capable of informing agency decisions.

Your co-authors have covered a number of advisory committee meetings of outside experts over the past decade, so we have been closely watching Califf’s efforts to reform how those important meetings are held.

Former FDA Commissioner Scott Gottlieb called the push a reasonable step that doesn’t preclude the agency from polling committee members for input on certain products.

“A lot of the things the FDA is looking to the advisory committees for perspective on aren't binary questions or binary circumstances,” Gottlieb told POLITICO. “They’re issues of judgment and particularly issues related to how technology is going to intersect with clinical practice, where the agency doesn't have as much experience."

But lawmakers, advisory committee members and health policy experts say cutting down on voting does not make sense.

“If you don’t have the vote at the end, it opens the door to selective interpretation of a long, extensive written record of the day’s discussion,” said Dr. Aaron Kesselheim, a professor at Harvard Medical School and former advisory committee member. “So I think that voting is an essential part of the process.”

Sen. Joe Manchin (D-W.Va.) pressed Califf on Wednesday at a Senate hearing on why the agency would reduce the number of votes held by advisory committees, questioning how it could increase public understanding of FDA decisions.

“I don’t know if anyone is advocating taking voting completely away,” Califf responded. “What the FDA is most interested in is what the advisory committee is thinking — what’s behind the reasoning for the way they feel the way they do.”

Califf has said the public sometimes mistakes an advisory committee vote as a final FDA decision, drawing an undue amount of media attention to a recommendation that the agency is not bound to follow.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said Califf and other FDA leaders want to get rid of “a lot of the votes” in large part to avoid media scrutiny that could embarrass the agency.

“They think it'll make their job easier, but for those of us who care about how safe and effective these products are, we think that getting rid of those votes is going to provide less information,” Zuckerman said. “The FDA is having a listening session on this topic, but I think they've already decided what they’re going to do.”

What’s next: The agency will hold a meeting next month to discuss how the panels operate.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We are admiring Bloomberg Money Stuff’s newsletter email subject line from Thursday: "Bed Bath Strikes From the Beyond."

Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.

Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.

Eye on the FDA

Medical personnel prepare for the final stage of Lasik eye surgery.

The FDA has clarified how modifications to medical devices are classified. | Charles Rex Arbogast/AP

REMANUFACTURING DEVICES — The FDA clarified on Thursday whether changes to a medical device are classified as servicing — restoring, refurbishing or repairing a product — or remanufacturing, where changes made significantly impact a product’s safety or use.

If unintentional remanufacturing occurs, a device might fall out of compliance with federal law when it is altered from the product that the FDA approved, cleared or authorized.

“This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health.

In 2016, the agency began working to clarify the role of remanufacturing and servicing by soliciting feedback from the medical device industry and the public. Medical device lobby AdvaMed said it was reviewing the final guidance.

USER-FEE CHECK-IN — The FDA’s annual meeting to examine the financial status and efficiency of the three primary medicine user-fee programs will be held on June 6. The agency will present five-year financial plans for the brand-name, biosimilar and generic drug user-fee programs at this year’s meeting.

Industry Intel

BIO: CHINA TIES WIDESPREAD — A survey released this week shows that most drug companies polled by a biotech lobby have at least one deal with a Chinese contractor and would need years to find new manufacturing partners if Congress passes biosecurity legislation this year.

The Biotechnology Innovation Organization survey results come as House Republicans are expected next week to mark up the bill, which would essentially prohibit Chinese biotech companies from doing business in the U.S.

Nearly 80 percent of the 124 companies that responded to the survey, conducted primarily in April, said they have at least one such contract, and they estimated it would take up to eight years to unwind those deals. More than two-thirds of the companies are small biotechs with fewer than 250 employees, BIO said.

“We must thoughtfully and over a reasonable period of time work to decouple our dependence and regain U.S. biomanufacturing dominance to advance our national security and public health interests,” BIO President and CEO John Crowley said in a statement.

In the Courts

CRISPR CASE HEADS TO COURT — A federal appeals court heard oral arguments this week between the regents of the University of California and the Broad Institute over who was the primary inventor of CRISPR-Cas9 gene editing — a technique that allows for the editing of the genome.

Jacob Sherkow, a biotech patent law expert at the University of Illinois at Urbana-Champaign College of Law, told Prescription Pulse that the three-judge panel of the U.S. Court of Appeals for the Federal Circuit seemed inclined to kick the case back to the patent office so that the two scientists awarded the Nobel Prize for discovering the technology, Jennifer Doudna and Emmanuelle Charpentier, can have their earliest patent applications validated.

Background: Doudna, who is affiliated with the University of California, and Charpentier are credited with creating CRISPR. But the Broad Institute — a genomic research partnership between the Massachusetts Institute of Technology and Harvard University — holds the U.S. patents on editing human cells with CRISPR and claims it was the first to apply the innovation to living cells.

“The underlying facts have not changed, and we are confident in the outcome the [Patent Trial and Appeal Board] reached based on evaluation of the extensive record,” Broad spokesperson David Cameron said.

Takeaways: For biotechs seeking to develop a CRISPR therapy, Sherkow said, that outcome would mean they’d need to seek patent licenses from both parties rather than just Broad. He added licensing costs could come down from the deal struck with the makers of the first FDA-approved CRISPR treatment, which targets sickle cell disease.

The inventorship fight won’t affect the cost of gene therapies, Sherkow said, which are typically millions of dollars.

“Absolutely none of this under any reasonable interpretation is going to change what the retail sticker cost of these drug therapies are going to be — not by a dollar, not by a cent,” he said.

LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.

WHAT WE'RE READING

Senate HELP Committee ranking member Bill Cassidy (R-La.) wants to overhaul how the NIH is run if the GOP wins the Senate this fall, POLITICO’s Erin Schumaker reports.

STAT's Helen Branswell dives into why H5N1 has continued to surprise public health experts since it emerged 27 years ago.

Document Drawer

The Department of Justice announced it is forming an antitrust division task force to probe health care monopolies and collusion.

The FDA, the EPA and the USDA released a framework for coordinated regulation of biotechnology.

The DEA released its 2024 national drug threat assessment.

Follow us on Twitter