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Presented by 340B Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Katherine Ellen Foley | Presented by 340B Health | With help from Ben Leonard
| | |  The over-the-counter birth control pill is expected to be available early next year, but its price has yet to be determined. | Perrigo via AP Photo | NO PRESCRIPTION, BUT AT WHAT PRICE? The FDA made history Thursday by approving Opill, a drug from the generic pharmaceutical manufacturer Perrigo, Katherine and Alice Miranda Ollstein report. The company expects the progestin-only pill to be available in early 2024. But shedding the obstacle of needing a prescription comes with a potential out-of-pocket cost that could keep Opill from some would-be users. Insurance plans don’t generally cover over-the-counter products. The Affordable Care Act already requires insurers to cover birth control without cost-sharing but only with a prescription. Depending on the state consumers reside in, it’s possible that the state-administered Medicaid would cover Opill only if the drug is prescribed, POLITICO’s Robert King and Alice report. Several states allow workarounds to increase access to certain prescribed drugs, like allowing pharmacists to write prescriptions. This was a popular strategy for distributing Narcan, an overdose reversal nasal spray, before it received OTC approval. But requiring a prescription reinstates the barrier eliminated by selling the product over the counter, Greer Donley, an associate professor of law at the University of Pittsburgh, told POLITICO. For the uninsured and those who don’t feel comfortable using their insurance to purchase birth control — such as people in abusive relationships or minors whose parents don’t support their sexual activity — Opill’s retail price will greatly determine the drug’s uptake. In a call with reporters, Frédérique Welgryn, Perrigo’s global vice president for women’s health, said the company doesn’t yet have a suggested price but hoped to in the coming months. Welgryn added that Perrigo would focus on obtaining Medicaid and insurance coverage for Opill, but it wasn’t clear whether they would achieve that goal by the time the drug is available to consumers. According to a November KFF survey of reproductive-age women, only 16 percent of respondents said they could pay more than $20 a month for birth control compared with nearly 40 percent who said they could pay between $1 and $10. “This is probably a really good moment for the Biden administration to re-evaluate the contraceptive mandate,” said Donley. IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We hope you’re staying cool this week. Send news and tips to David Lim (dlim@politico.com or @davidalim or @david.a.lim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Katherine, who delves deeper into the implications of the FDA’s decision to approve the first-ever over-the-counter birth control.
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Rep. Richard Hudson is leading GOP negotiations for the reauthorization of PAHPA. | Meg Kinnard/AP Photo | PAHPA REAUTHORIZATION ADVANCES — The House Energy and Commerce Health Subcommittee advanced a narrow reauthorization of the U.S.’ emergency preparedness law to the full committee Thursday that did not include drug shortage reforms sought by Democrats. There are tentative plans to consider reauthorization of the Pandemic and All-Hazards Preparedness Act at a full E&C Committee markup on July 19, but the timing might slip to a later date, tentatively scheduled for July 27. Meanwhile, the Senate Health, Education, Labor and Pensions Committee will hold a markup of legislation to reauthorize PAHPA on July 20, according to Sen. Bernie Sanders (I-Vt.) spokesperson Mike Casca. Speaking of policies falling off PAHPA: Don’t expect a reauthorization of priority review vouchers for medical countermeasures to be included. Rep. Richard Hudson (R-N.C.), who is leading GOP negotiations to reauthorize the bill, told POLITICO that it is necessary to keep the bill narrowly focused to ensure it can pass on the House floor. Priority review vouchers need “to be addressed,” Rep. Buddy Carter (R-Ga.) said earlier this week. “It could be a standalone bill.” And FDA Commissioner Robert Califf met with Rep. Larry Bucshon (R-Ind.) Thursday to discuss regulation of laboratory-developed tests, the lawmaker told POLITICO. The FDA “may come out with rulemaking, which they think is in the best direction, but it’s always better for the legislative branch, for Congress to act,” Bucshon said. GOP TAKES CHAINSAW TO HEALTH FUNDING — House GOP appropriators are proposing to reduce federal spending drastically on various health agencies in their draft Labor-HHS spending bill, Ben reports. The House Appropriations Committee will meet today to mark up the fiscal 2024 bill. The legislation, likely to run into stiff Senate opposition, offers a 29 percent reduction in topline spending and would give HHS $103.3 billion — $14 billion less than fiscal 2023 levels. The bill would cut funding significantly for HHS agencies, including reducing CDC funding by $1.6 billion and NIH funding by $3.8 billion. It would eliminate funding for the Agency for Healthcare Research and Quality and at least a dozen other health care programs. The Advanced Research Projects Agency for Health would take a $1 billion hit, down to $500 million. Appropriators point out that the program has $1.5 billion in unspent dollars.
| | | | UNLEASH THE FUTURE OF HEALTHCARE WITH POLITICO, A 7/20 INTERACTIVE EVENT: Imagine a future where rare genetic diseases are not only treatable, but potentially curable. Where our approach to chronic illness takes a monumental leap forward. That future is already taking shape in the form of next-generation health care treatments such as gene therapy. Join POLITICO on Thursday, July 20 and delve into the burgeoning field of gene therapies, which hold the power to redefine our health care landscape. Are you ready to explore this new frontier in health care? Don't miss this chance to be part of the conversation. REGISTER NOW. | | | | | | | | VACCINES AT THE RIGHT PRICE — HHS Secretary Xavier Becerra sent a letter to Covid-19 vaccine manufacturers Thursday telling them their fall boosters should be priced at a “reasonable rate” as the vaccines are transitioned to the commercial market. “Price gouging behavior takes advantage of the trust the American people have placed in you through the Covid-19 response,” Becerra wrote, noting that he expects companies to work with CMS and private insurers to ensure consumers can afford the updated shots. HHS said Thursday that the CDC would buy some vaccines from manufacturers through its Bridge Access Program, which will provide vaccines for those who are uninsured or whose insurance doesn’t cover new shots.
| | J&J RELENTS ON SOME TB GENERIC ACCESS — Public health advocates, including Médecins Sans Frontières, or Doctors Without Borders, and author and YouTuber John Green, succeeded this week in pushing Johnson and Johnson to make a commitment toward expanding access to bedaquiline, the generic version of the tuberculosis drug Sirturo. The company said Thursday it would give Stop TB Partnership´s Global Drug Facility licenses to procure and distribute generic TB treatment to most low- and middle-income countries — including certain countries where patents remain in effect. According to the WHO, 1.6 million people died from tuberculosis in 2021 worldwide. The primary patent on bedaquiline expires next week, but the company has a secondary patent in many countries that MSF Access Campaign’s Christophe Perrin argues will still impede generic versions from proliferating. “While the included list of countries have yet to be made public, we have learned that the 9 countries in the Eastern Europe and Central Asia region, which have some of the world’s highest burden of drug-resistant TB, are excluded from this deal,” Perrin said in a statement. “We reiterate our call on J&J to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this lifesaving drug,” he added. J&J declined to comment on the issue of providing access to generic rivals in the countries cited by MSF Access Campaign.
| | The number of fatal drug overdoses in the U.S. remained steady at record levels between February 2022 and February 2023, POLITICO’s Carmen Paun reports. A smoking cessation drug candidate in late-stage trials helped more people abstain from cigarettes than a placebo, Saša Jankovic reports in The Pharmaceutical Journal.
| | | | A message from 340B Health:   | | | | | The PhRMA Foundation announced that Robert Plenge, head of research at Bristol Myers Squibb, is joining its board of directors. The National Abortion Federation named Brittany Fonteno as president and CEO, beginning in September. Fonteno is currently the president and CEO of Planned Parenthood Arizona.
| | | | 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. | | | | | | | | | The FDA published draft guidance Wednesday on acceptable manufacturing changes and comparability for cell and gene therapies. The FTC tentatively plans to vote on issuing a statement on July 20 to caution against use of pharmacy benefit manager studies “that no longer reflect current market realities.” CMS issued a proposed national coverage determination to cover pre-exposure prophylaxis for people at high risk of developing HIV.
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