EXPERTS TO DISCUSS OTC BIRTH CONTROL PILL — Today and tomorrow, two FDA expert advisory committees meet to discuss whether a birth control pill can be sold directly to consumers, Katherine and POLITICO’s Alice Miranda Ollstein report.

The experts’ recommendations are nonbinding, and the agency isn’t slated to make a decision until this summer. But ahead of this week’s two-day meeting, the FDA indicated it doesn’t believe data support that consumers could correctly use the pill without the oversight of a health care provider — worrying some reproductive rights advocates that the agency might not approve the pill to be sold over the counter.

The agency’s unexpected take on HRA Pharma’s application puts the Biden administration in a difficult spot. It doesn’t want to be seen as interfering with the FDA’s scientific conclusions even as it aggressively works to strengthen reproductive rights.

As part of its application, HRA Pharma conducted a clinical trial with roughly 900 participants who reported taking the pill, called Opill, correctly — including using backup contraception if they missed a pill — more than 90 percent of the time. But FDA briefing documents posted Friday show agency staff aren’t convinced consumers will understand that Opill must be taken “the exact time every day on a daily basis to ensure prevention of pregnancy.” The FDA staff also said today’s potential consumers aren’t the same as the clinical trial participants from 1973 when the pill was approved for prescription use.

The FDA tries to steer clear of politics, but some experts fear it will be impossible for the agency to avoid getting tangled up in a heated political environment, particularly after the Supreme Court last year overturned the Roe v. Wade precedent that had legalized abortion in the U.S. for more than 50 years. “We can’t pretend that this is happening in a vacuum outside of politics,” Greer Donley, an associate professor at the University of Pittsburgh law school, told Katherine. “All of these decisions are also political.”

Reproductive health advocates have long argued that an over-the-counter birth control pill would increase access to contraception and decrease unwanted pregnancies — which they say is critical as access to abortion shrinks across the country. Anti-abortion groups, meanwhile, have petitioned the FDA to nix the pill’s OTC approval, expressing concerns about its safety and accessibility for minors and whether it would be dangerous in light of the nation’s high rates of sexually transmitted infections.

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Congratulations to our colleagues Alex Ward, Josh Gerstein, Peter Canellos, Heidi Przybyla and Hailey Fuchs for being named Pulitzer Prize finalists for their coverage of the Supreme Court last year.

Send news and tips to David Lim ([email protected] or @davidalim) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with POLITICO’s Maya Kaufman about a first-of-its-kind, federally-funded study that will evaluate the impact of overdose-prevention centers in New York City and Providence, R.I., on future public health policy.

CALIFF: AI REGULATION IS NEEDED — Regulating artificial intelligence using the FDA’s existing authorities “is a big challenge” because the field is evolving so rapidly, FDA Commissioner Robert Califf said Monday.

The agency’s leader said large-language models — such as ChatGPT — could free up doctors, allowing them to spend more time talking with patients during a visit instead of inputting data into electronic health records. But, he added, regulating models “is critical” to ensure they improve outcomes and don’t cause harm.

“If we’re not nimble in the use and regulation of large-language models, we’ll be swept up quickly by something that we hardly understand,” Califf said at the Science of Patient Engagement Symposium in Washington. “We have good reason to hope that we will fulfill the enormous potential of digital health technologies and see more innovative solutions that can result in improved outcomes, but we’d better also preempt the risks.”

SLATE OF HEARINGS — A busy week for Congress on the health front.

People who care about regulating pharmacy benefit managers and improving access to generic drugs will be closely watching the Senate HELP Committee’s scheduled bill markup on Thursday.

Last week’s hearing to focus on the bill markup ground to a halt after ranking member Bill Cassidy (R-La.) accused Chair Bernie Sanders (I-Vt.) of abandoning commitments made during markup negotiations by unexpectedly moving to allow the consideration of a number of bipartisan amendments. As of Monday, the committee appeared to be back on track and plan to advance a bipartisan package out of committee to a possible floor vote.

Here’s a list of other hearings this week we’re tracking:

Tuesday:

— The House Veterans’ Affairs Technology Modernization Subcommittee holds a hearing on pharmacy electronic health record modernization.

Wednesday:

— The Senate HELP Committee hears from senior executives of Eli Lilly, Novo Nordisk and Sanofi on insulin pricing and from CVS Health, Express Scripts and OptumRX on pharmacy benefit managers.

— The House Ways and Means Health Subcommittee holds a hearing on policies that negatively impact medical innovation.

Thursday:

— The Senate Finance Committee discusses pharmaceutical company international tax policy. Chair Ron Wyden (D-Ore.) claims many drugmakers are actively avoiding taxes owed to the federal government.

— The Senate HELP Committee reconvenes its markup of PBM and generic drug legislation that it started on Wednesday.

RJR KEEPS NEW CIGARETTES ON CALIFORNIA SHELVES — California Attorney General Rob Bonta warned tobacco giant R.J. Reynolds in April that its new “non-menthol” products violate the state’s ban on flavored tobacco products. But the company said Monday it has no plans to pull the new products off the market.

“The letters from the California Attorney General’s office were issued in error,” said Luis Pinto, a spokesperson for R.J. Reynolds, in a statement to Prescription Pulse. “The letters merely presume that the products have a characterizing flavor based solely upon the State AG’s review of packaging and promotional materials, not the products themselves. We stand by our products and will respond to the letters appropriately to ensure these lawful products remain available for sale.”

For POLITICO, David, Daniel Payne and Ben Leonard explain what will end and what won’t as the U.S.’ Covid health emergency expires this week.

Some scientists believe that weight-loss drugs like Ozempic could slow the progression of neurological diseases like Alzheimer’s, Natalie Grover reports for Reuters.

The FDA will hold a webinar on May 15 to discuss the three major types of meetings it can hold regarding the Generic Drug User Fee Amendments: pre-submission, post-complete response letter and product-specific guidance.