DRAFT SCOTUS OPINION CASTS SPOTLIGHT ON OTC BIRTH CONTROL — The real possibility of the Supreme Court overturning federal protections for abortion is renewing a sense of urgency for advocates of making oral contraceptives available over the counter, POLITICO’s Lauren Gardner writes. The yearslong effort is expected to yield one formal application to the FDA later this year, with another likely a few years behind. Daily birth control pills boast a 60-year history of data showing they’re safe and effective. But they’ve remained accessible only to those who can visit health providers to prescribe them, putting the pills out of reach for many low-income and rural communities and people of color. With more barriers to reproductive health expected in the states and a favorable data profile, proponents of OTC birth control say the FDA shouldn’t delay in approving this first-in-class switch from prescription-only status once formal applications are in hand. But the two companies that have worked with the FDA over the last six years on studies needed to win regulatory approval aren’t over the finish line just yet. One, Cadence Health, has had to rework its label after the agency called for the company to monitor trial participants’ blood pressure — uncontrolled hypertension is one of a handful of health conditions for which doctors currently advise patients to avoid certain formulations of oral contraceptives. Still, proponents say the political moment, combined with decades of advocacy to move the pills in front of the pharmacy counter, stands to make OTC birth control another tool to avoid unintended pregnancies. SENATE DEMS WEIGH ROE PLANS — Senate Democrats are gearing up for an abortion-rights vote next week in response to the breach of a draft opinion, obtained by POLITICO, that showed a Supreme Court majority prepared to overturn Roe v. Wade. They fully expect it to fall short of even 50 votes, write our Marianne LeVine and Alice Miranda Ollstein. The abortion access bill’s lead sponsor, Sen. Richard Blumenthal (D-Conn.), tweaked it to appease worries from moderates, stripping out some nonbinding language about abortion that raised some objections. But it’s far from clear that Sen. Joe Manchin (D-W.Va.), an abortion-rights opponent, would vote differently than he did in February when he opposed the Democratic bill. “There were some language challenges with the original version, and I think they’re trying to eliminate those concerns,” said Sen. Tim Kaine (D-Va.). “They’re taking care of that. Is that enough to get Manchin’s support? I don’t know.” Meanwhile, the GOP’s two pro-abortion-rights senators, Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska), are still pressing for a vote on the narrowest possible Roe-preserving measure — despite Democratic leaders’ disinterest in it so far. With the legislative filibuster still intact, requiring 60 votes to pass most bills, Democrats acknowledge the coming Senate floor vote will be largely symbolic. Still, party leaders argue it’s needed to put senators on the record given the heightened stakes on abortion rights following the breached draft opinion. HOUSE E&C COMMITTEE UNVEILS FDA USER FEE PACKAGE — On Wednesday, top lawmakers on the House Energy and Commerce Committee published bipartisan legislation that would reauthorize the FDA’s medical product user fee programs, David and POLITICO’s Katherine Ellen Foley report. The bill also contains several policy riders that would bolster FDA’s authorities, tweak market pathways and task the agency with new responsibilities. The House E&C health subcommittee is slated to mark up the user fee package next week, according to a committee aide. The goal is to have the legislative package on President Joe Biden’s desk by August, well before the current five-year user fee programs expire at the end of September, according to House E&C Chair Frank Pallone (D-N.J.), ranking member Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Anna Eshoo (D-Calif.) and Health Subcommittee ranking member Brett Guthrie (R-Ky.).
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