| | | | |  | | By Lauren Gardner and David Lim | | Presented by |  | | | | | | | 
Two pills used for medication abortions are in the crosshairs of Louisiana, which wants them to be classified as controlled substances. | Charlie Neibergall/AP | ‘CONTROLLING’ THE ABORTION PILL NARRATIVE — The Louisiana state legislature will consider a bill this week to classify mifepristone and misoprostol — the two drugs used in medication abortion — as controlled substances, subjecting anyone without a valid prescription for the drugs to possible jail time. The legislation, part of an effort to criminalize abortion in cases in which someone gives a pregnant woman the pills without her consent, would be the first instance of a state declaring those drugs controlled substances, a category of medications that typically have the potential for abuse. “It’s startling to have a state try to reconfigure an entire regime of how controlled substances are vetted and prescribed, and what oversight they receive on the back of an anti-abortion strategy,” Rachel Rebouché, a reproductive law expert and dean of Temple University’s Beasley School of Law, said. “This is what Dobbs wrought.” States can vary their controlled substances penalties from the federal system, applying looser or stricter punishments depending on an individual state’s priorities and resources targeting certain drugs. But Louisiana’s unprecedented move is part of a broader effort — represented by anti-abortion groups’ Supreme Court challenge of FDA policies broadening access to medication abortion — to “paint them as dangerous,” Rebouché said of mifepristone and misoprostol. “There’s not a threat of overdose,” she said. “There’s not a threat of addiction.” The FDA and the DEA did not respond to requests for comment on what such a state legislative change would mean for federal regulators. Abortion is already illegal in nearly all instances in Louisiana. Rebouché said she suspects the legislation is intended to chill efforts by abortion proponents and providers in states where abortion is legal to mail pills to pregnant people in states like Louisiana and women who try to order the drugs to have on hand. “When drugs are highly scheduled, the access tends to go down,” said Dr. Joshua Sharfstein, a former FDA official who’s now vice dean at the Johns Hopkins Bloomberg School of Public Health. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. The FDA’s new rule governing how pharma ads on radio and TV present drug information went into effect Monday, but drug promotions on social media remain untouched by regulation. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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Under a new CEO, the Biotechnology Innovation Organization, a biotech trade association, will undergo a restructuring. | Ben Margot/AP | BIO LAYS OFF 30 — The Biotechnology Innovation Organization is going through another set of changes as John Crowley, who became CEO of the industry group in March, makes his mark, POLITICO’s Megan R. Wilson reports. Crowley said on a Monday call that the group would restructure, which would include “exiting” 30 employees. The departures include some top execs, including its chief policy officer, John Murphy, and chief public affairs and marketing officer, Rich Masters. In a call with members, BIO said Chief Science Officer Cartier Esham, who has been with the organization for more than 16 years, would stay on for “a period” to serve as a senior adviser, a person who was on the call told Megan. Crowley said he’s had conversations with BIO’s board and the group’s member companies that made it “clear that in our efforts to do everything, we were missing the opportunity to do many of the big things,” per an email Megan obtained. In the email, Crowley told members that the group would be “aligning around Eight Centers of Excellence” that reflect the group’s top priorities. BIO’s top lobbyist, Aiken Hackett, will lead the federal government affairs department and Patrick Plues, vice president of state government affairs, will lead its state advocacy efforts, per the Monday call. Michele Oshman, vice president of external affairs, is being elevated to lead BIO’s patient advocacy department, and Phyllis Arthur, senior vice president for infectious diseases, will lead BIO’s policy and programs department. The moves come about a month after Crowley fired its head of advocacy, Nick Shipley. BIO has been through four CEOs in about four years. In 2022, then-BIO CEO Michelle McMurry-Heath stepped down following clashes with the group’s board.
| | | | 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. | | | | | | | | HIMS LAUNCHES COMPOUNDED GLP-1 SHOT — Hims & Hers Health said Monday it is launching compounded GLP-1 injections with the same active ingredient in weight-loss drugs Ozempic and Wegovy. The partnership with an unnamed 503B compounder — a bulk manufacturer of those medications — is likely relying on regulatory flexibility granted to compounders for when a brand drug is in shortage. An FDA database of outsourcing facilities lists PQ Pharmacy and Olympia Pharmacy as making compounded semaglutide injections and ProRx making compounded semaglutide solution as of the second half of 2023. The use of compounded weight-loss drugs has grown as supply of Novo Nordisk’s and Eli Lilly’s branded drugs remains in shortage, though the FDA and the industry don’t have a sense of how much compounded drugs factor into the domestic GLP-1 supply. Novo Nordisk said that compounding pharmacies are getting semaglutide from other entities. “Novo Nordisk has filed 12 lawsuits nationwide against medical spas, weight-loss clinics and compounding pharmacies engaging in unlawful marketing and sales of compounded drugs claiming to contain semaglutide,” Novo Nordisk spokesperson Allison Schneider said in an email. Hims spokesperson Abby Reisinger said the company is partnering with BPI Labs to make the injectable products.
| | | | A message from CVS Health:   | | | | | PUBLIC CITIZEN SUES FDA — Consumer advocacy group Public Citizen wants a court to compel the FDA to act on a 2018 citizen petition that sought to have labels for certain depression drugs revised to note “persistent, worsening, or new symptoms of sexual dysfunction after stopping use.” The lawsuit, filed in the U.S. District Court for the District of Columbia, argues that the FDA violated the Administrative Procedure Act by not taking action on the petition. The FDA said it doesn’t comment on pending litigation.
| | CONTRACEPTION ACCESS VETO — Virginia Gov. Glenn Youngkin vetoed legislation last week that would have created an enforceable right to contraception in the state, prompting Democrats to say his move aligns with presumptive GOP presidential nominee Donald Trump. “Let me be crystal clear: I support access to contraception,” the Republican said in a statement. “However, we cannot trample on the religious freedoms of Virginians. And that is the issue the recommendations I sent back to the General Assembly addressed.” The pushback: The bill’s proponents said an amendment Youngkin had proposed would render the legislation a nonbinding policy statement. State Sen. Ghazala Hashmi and Del. Marcia Price said in a statement that the Democrats would continue to reintroduce the legislation “year after year until this bill is signed and the vital health care that Virginians rely on is protected.” And the Democratic Governors Association said Monday that Youngkin’s veto “has ensured that access to reproductive health care will be on the ballot in the next race for Virginia governor.” In Arizona: Democratic Gov. Katie Hobbs issued an executive order Monday deeming Opill and any future over-the-counter hormonal birth control methods an “essential health benefit” available with no cost-sharing for state health plan participants. The state’s GOP-led legislature declined to consider similar right-to-contraception legislation this year.
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| | | The Senate Judiciary Committee meets today at 10 a.m. to discuss competition in the prescription drug market. The leaders of the FDA’s drug, biologic and medical device centers will testify before the House Energy and Commerce Health Subcommittee on Wednesday at 10:30 a.m.
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