An old FDA chart limits access to new kinds of birth control

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Aug 19, 2022 View in browser   By Katherine Ellen Foley, Lauren Gardner and David Lim On Tap — Health plans' reliance on the FDA's informational chart on birth control options has made it more difficult for patients to access novel contraceptives at no cost. — Former FDA chief of staff will lead the Reagan-Udall evaluation of the agency's tobacco program. — The federal government knew for years it didn't have enough of the smallpox vaccine key to combating monkeypox. It's Friday. Welcome to Prescription Pulse. In D.C. this weekend? Don't forget to check out Chuck Brown Day in Langdon Park on Saturday and enjoy some fresh go-go jams. Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ).   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     Eye on the FDA Payers and pharmacy middlemen are using an outdated FDA educational chart to limit access to new birth control methods. | Kevork Djansezian/Getty Images FDA LIST TIED TO CONTRACEPTION COVERAGE WOES — Payers and pharmacy middlemen are unfairly relying on a years-old FDA educational chart to limit access to new birth control methods that don't yet have cheaper generic competition, manufacturers and contraceptive access advocates told Lauren. At issue is a chart developed by the agency to educate the public on more than a dozen FDA-approved contraceptive options that, over time, became entwined with federal guidelines spelling out how health plans could meet Affordable Care Act requirements aimed at providing free birth control to Americans. Guidance issued in 2015 made clear that plans were expected to cover at least one birth control method in 18 contraceptive categories the FDA had identified — language intended to prevent payers from agreeing to cover, say, birth control pills but not intrauterine devices. But over time, new drugs are at a disadvantage, advocates say, because they are either first-in-class products with no obvious category on the existing list or belong to an established class but boast unique formulations or dosages that could make them the first choice for patients, but not to payers trying to keep costs low. Patients and their providers can still petition plans to fully cover branded drugs if they're deemed medically necessary, but the process is time-consuming. Federal agencies say they continue to receive reports of noncompliance and have threatened enforcement action against wayward plans. Payers say they already cover the vast majority of birth control options available to consumers and are within bounds to steer them toward cheaper generics while acknowledging the requirement to defer to providers who say certain branded drugs are necessary for certain patients. Manufacturers of newer contraceptive options suggest the tide is shifting in their favor now that the Supreme Court has overturned Roe v. Wade and raised questions about the future of the court's longstanding precedents on birth control access. "These plans are denying women, not complying with what is a mandate, and they are making up interpretations to not provide women access," Evofem CEO Saundra Pelletier, whose company makes a nonhormonal gel called Phexxi, told POLITICO. FORMER FDA CHIEF OF STAFF TO INDEPENDENTLY REVIEW TOBACCO OFFICES — Lauren Silvis, a former chief of staff at the FDA and senior adviser at HHS, has been tapped by the Reagan-Udall Foundation to lead an independent review of the tobacco regulatory programs at the agency, Katherine reports. Silvis will helm an expert panel that collects information about the Center for Tobacco Products, including anonymous input from staff, and develops recommendations for updating its premarket reviews, compliance and enforcement procedures. FDA Commissioner Robert Califf in July called for the foundation's review of the tobacco, food safety and inspections programs following widespread criticism of the agency this year. A regulatory veteran: During her tenure as chief of staff, Silvis worked closely with former FDA Commissioner Scott Gottlieb. "Lauren helped lead the strategy around our efforts, including the comprehensive plan we announced to put nicotine at the center of our regulatory efforts, but also FDA's enforcement strategy as the agency worked to curtail the youth abuse of vaping products," Gottlieb told Prescription Pulse. "It's an inspired choice," said David Kessler, the chief science officer of the White House's Covid Response team and another former FDA commissioner. "She cares deeply about the agency, and she's extremely well positioned to bring the tobacco program toward the future." And on the food side: Jane Henney, the Clinton-era FDA commissioner who was initially brought in to spearhead the agency's external review, will focus on food safety. According to the foundation, Henney will evaluate the program's leadership, structure, resources and culture. Monkeypox The Strategic National Stockpile's supply of vaccines to fight monkeypox is running lower than recommended. | AP Photo/Sue Ogrocki U.S. OFFICIALS KNEW FOR YEARS THEY DIDN'T HAVE ENOUGH OF KEY SHOT TO FIGHT MONKEYPOX — Top U.S. health officials have known for years that, because of inadequate funding, the country's Strategic National Stockpile did not have enough doses of a smallpox vaccine that is now key to battling the monkeypox outbreak, POLITICO's Erin Banco and Helen Collis report. The Strategic National Stockpile was supposed to have about 120 million Jynneos doses, enough for 60 million people, in the event of a smallpox outbreak. Before 2019, the U.S. had just 20 million doses — even though the government could afford 40 million at the time. Money for Jynneos shots competed with funding for priorities and threats the administration perceived as more pressing. In 2020, the U.S. purchased just over 1 million doses to replenish expired vaccines. "That's not preparedness," said a federal health official who was granted anonymity to speak candidly. "It's like telling the military … 'you have a requirement for 100 airplanes, but we're only gonna give you 10 because that's all we can afford.' And then we have to fight. Good luck." LGBTQ ADVOCATES FEAR FEDERAL MONKEYPOX RESPONSE MISSES COMMUNITIES OF COLOR — LGBTQ health advocates and public health experts are concerned that the federal and state responses to monkeypox are repeating the mistakes of the coronavirus pandemic and the HIV epidemic by ignoring the impact on communities of color, POLITICO's Krista Mahr and Megan Messerly report. Early data suggest Black and Latino men who have sex with men are far more likely to catch monkeypox than their white counterparts. It's unclear why communities of color are once again being hit so hard, but public health experts believe a lack of targeted outreach to those communities is aggravating existing disparities. Federal health officials said they are determined to eliminate the disparities. The CDC has worked with community-based organizations to spread the word through pop culture icons like Shea Couleé from "RuPaul's Drag Race" and Billy Porter from the FX TV series "Pose." But advocates say those efforts aren't enough. "We had a chance to do better," said Matthew Rose, a longtime health equity and HIV advocate. "We know the challenges from Covid. It's so important to find trusted messengers, but we continue to do broad-based messaging. Then we wait and say, 'Look at all this disparity again.'" Coronavirus HHS SIGNALS PUBLIC HEALTH EMERGENCY WILL BE EXTENDED — State and local public health officials — having not heard differently this week — are expecting the Biden administration to extend the Covid-19 public health emergency for another 90 days in mid-October, David reports. HHS had said it would alert officials 60 days before the PHE is due to be terminated, a timeline that passed earlier this week. "The COVID-19 Public Health Emergency remains in effect, and as HHS committed to earlier, we will provide a 60-day notice to states before any possible termination or expiration," an HHS spokesperson told POLITICO.   INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don't miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     Industry Intel FDA APPROVES GENE THERAPY TO POTENTIALLY CURE RARE BLOOD DISEASE — On Wednesday, the FDA approved Zynteglo , a cell-based gene therapy to treat beta thalassemia from the biotech company Bluebird Bio. For roughly 850 patients in the U.S., managing the rare genetic disease requires some patients to receive a lifetime of blood transfusions. After one treatment with Zynteglo, 90 percent of patients in a clinical trial stopped needing them for at least a year. As a gene therapy, those changes are expected to be permanent. The first-of-its-kind treatment is also one of the most expensive: Bluebird priced Zynteglo at $2.8 million per person. And that figure doesn't cover the fees from the hospitalization required to receive the treatment. The company is asking for insurers to foot the bill entirely. Stay tuned. Pharma Moves Moderna has named James Mock as its chief financial officer beginning next month. Cody Sargent will be press secretary for Senate HELP member Tommy Tuberville (R-Ala.). He currently is a director in the public affairs practice at PLUS Communications. Carl Meacham is joining FTI Consulting as a managing director for strategic comms. He previously led trade group PhRMA 's commercial diplomacy and advocacy efforts for Latin America, Canada and Europe. Philips announced Roy Jakobs will replace Frans van Houten as president and CEO of the device maker. Document Drawer FDA issued a warning letter to a company selling nicotine gummies without marketing orders — the first letter of its kind. The National Cancer Institute announced Thursday that four academic institutions will be awarded $23 million to establish research centers that will study how cancer-related health care is delivered via telehealth.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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