The FDA backtracks on its fast track

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Oct 17, 2022 View in browser   By Krista Mahr and Daniel Payne Presented by With help from Daniel Lippman and Alice Miranda Ollstein  Driving the Day The FDA will argue this week to pull a drug off the market that it granted accelerated approval in 2011. | Andrew Harnik/AP Photo WHEN ACCELERATED APPROVAL DOESN'T GO AS PLANNED — The FDA will argue this week to take a drug off the market that it granted accelerated approval in 2011, underscoring the risks and complications of the increasingly controversial program, POLITICO's Lauren Gardner reports . A panel of independent expert advisers will meet starting today to decide whether to recommend that Makena, an injection marketed as lowering the risk of preterm birth, remain available for at least some patients. The FDA has been trying to pull the drug for years. The backstory: The FDA granted accelerated approval to Makena after a trial showed a statistically significant difference between the injection and a placebo in lowering the rate of preterm birth. But the results of a subsequent clinical trial required for all drugs granted expedited approval showed it isn't effective in improving the health of preterm babies or reducing the risk of preterm birth. The results prompted external FDA advisers in a 2019 split vote to recommend the agency pursue pulling the drug from the market. The FDA's drug center then proposed in October 2020 that Makena's approval be withdrawn. The drug's sponsor, which has changed over the years, and some patient groups say the drug should remain available because it could benefit a subset of pregnant people at high risk for preterm birth, including Black women, and because no other treatment options are available for those patients. The big picture: The accelerated approval program, which includes pricey and sometimes controversial drugs for Alzheimer's disease and cancer, allows drugmakers to sell products before trials confirming their clinical benefit are complete. It gives patients with serious conditions early access to potentially life-changing treatments. But when treatments turn out to be ineffective, it can take a long time to pull them off the market, leaving drugs with questionable benefits and possible risks available for years before regulators take action. A recent report from the Department of Health and Human Services' Office of Inspector General found that more than a third of drugs granted accelerated approval have incomplete confirmatory trials. WELCOME TO MONDAY PULSE — Happy Monday to you. In case you missed it, the White House was lit up in pink last night to honor those who have fought breast cancer. October is Breast Cancer Awareness Month. Send your news and tips to kmahr@politico.com and dpayne@politico.com . TODAY ON OUR Pulse Check Podcast , Grace Scullion talks with Lauren Gardner about the worrisome state of America's mental health and what lawmakers propose to do about it. Plus, David Lim on the FDA's new rule allowing the sale of over-the-counter hearing aids, which goes into effect today. Listen to today's POLITICO Pulse Check podcast!   A message from PhRMA: The 340B program may be driving up costs for some patients. A new analysis finds average costs per prescription for a patient is more than 150% greater at 340B hospitals than at non-340B hospitals. It's time to fix the 340B program. Learn more.   Abortion HHS' Office for Civil Rights is investigating CVS, Walgreens and other pharmacies that have implemented new restrictions on filling prescriptions in states that have outlawed abortion. | Scott Olson/Getty Images | Getty HHS INVESTIGATES PHARMACIES FOR MEDICATION REFUSALS IN STATES WITH ABORTION BANS — HHS Secretary Xavier Becerra announced over the weekend that the agency's Office for Civil Rights has opened investigations into CVS, Walgreens and other pharmacies that have implemented new restrictions on filling prescriptions in states that have outlawed abortion, Alice reports. The announcement comes about three weeks after POLITICO reported that patients across the country are having difficulty obtaining medication for conditions that include lupus, rheumatoid arthritis, acne and miscarriage because of pharmacies' fears that the same drugs could be used to terminate a pregnancy. "HHS has received complaints about chain pharmacies across the U.S. for not complying with their federal obligations to fill prescriptions," Becerra said . In a statement, Walgreens said the company has "taken steps to comply with applicable laws." "Our pharmacists will continue to work closely with prescribers as necessary to fill lawful, clinically appropriate prescriptions," Fraser Engerman, Walgreens' senior director of external relations, said in an emailed statement to POLITICO. "Our top priority is ensuring our patients have access to the medications they need from pharmacists they know and trust. We will cooperate with HHS and any other government agency seeking more information about our policies to dispense medications." CVS didn't immediately respond to questions about the investigations. FIRST IN PULSE — Reps. Mondaire Jones (D-N.Y.) and Diana DeGette (D-Colo.) will introduce a resolution today urging Congress to protect access to reproductive health care by reaffirming the FDA's authority to preempt state law and ensure access to reproductive health care products. The resolution reaffirms the FDA's preemptive authority over state laws that seek to regulate approved drugs and biologics, as established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Co-sponsored by 28 other House members, the resolution is endorsed by Planned Parenthood Federation of America, the National Women's Law Center, the Center for Reproductive Rights, and other national organizations. ALL EYES ON MICHIGAN — The country's highest-stakes battle over abortion rights is unfolding in Michigan, where polls indicate voters are likely to add the explicit right to the procedure in their state constitution, Alice reports . Abortion-related initiatives are also on the ballot in California, Kentucky, Montana and Vermont, but the outcome in Michigan will have the starkest impact — determining whether the state's 1931 anti-abortion law remains on the books. The scene: In the final sprint to Election Day, both sides are pouring money into TV ads, mailers, and phone banking plus recruiting staff and thousands of volunteers to knock on doors across the state. The campaigns pitch their message in churches, on college campuses, at local chambers of commerce and in labor union halls, with each side painting a bleak picture of what could happen in the state if they lose. The stakes: If it passes, the state would become the first to overturn an anti-abortion law since the Supreme Court overturned Roe v. Wade in June and bolster abortion rights advocates' conviction that ballot initiatives are their most viable path to restoring access in Republican-controlled states. Coming after August's decisive victory for the abortion-rights side in Kansas, a vote to overturn the law would likely fuel efforts to put the issue on ballots in several more states in 2023 and 2024. If the law isn't overturned, the outcome would support anti-abortion advocates' arguments that Kansas was a fluke and Republican efforts to paint Democrats as extremists who want no restrictions on abortion are an effective campaign tactic.   TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO's must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING .     Coronavirus U.S. LAGS ON NASAL VAX — Biden administration officials are worried about the U.S. lagging behind other countries in developing a Covid-19 nasal vaccine, POLITICO's Carmen Paun and Adam Cancryn write . The slow pace of development could pose a security risk and put the country at a global disadvantage if a dangerous new variant emerges, they say. U.S. researchers are studying nasal and oral vaccines, but none are close to coming on the market. Big pharmaceutical companies are also not investing in the next-generation vaccines because they don't see much profit potential. Who's got one? India, Russia and Iran have all authorized nasal vaccines, though none have yet been proven to stop Covid transmission. China already has a Covid vaccine that's ingested through the mouth. FAUCI TALKS TRUMP ROLLER COASTER — White House chief medical adviser Anthony Fauci recalled the highs and lows of former President Donald Trump's Covid-19 response on Sunday, POLITICO's Olivia Olander reports . In an interview on ABC's "This Week," he lauded Operation Warp Speed as "a very positive thing" and the former president should get credit where it's due for his administration's vaccine campaign. But he also reflected on what he viewed as the more difficult moments of advising Trump, saying he had "a bad feeling" about the April 2020 briefing in which Trump suggested injecting disinfectants to fight Covid, before the briefing even started.   A message from PhRMA:   Midterms Watch The Medicaid expansion campaign may be drawing to a close. | Dirk Lammers/AP Photo END OF AN ERA FOR MEDICAID EXPANSION — South Dakota voters are poised to expand their state Medicaid program to more than 40,000 people in November, but it could be the last major win for the progressive campaign to broaden Obamacare's reach in deeply red states, POLITICO's Megan Messerly reports . If voters approve the referendum, South Dakota will be the seventh Republican-controlled state in the past five years to expand the low-income insurance program at the ballot box. Eleven other states haven't expanded Medicaid, but only three — Florida, Mississippi and Wyoming — allow voters to collect signatures for a ballot measure, and none appear likely to take up the effort in the near term. For Democrats who hoped Medicaid expansion would be a step toward universal access for low-income Americans, South Dakota signals the end of a protracted battle that's added 17 million low-income Americans to the insurance rolls but has fallen short of reaching every state. Some 4 million Americans — about half of whom live in Florida and Texas — still fall into a coverage gap, according to the Kaiser Family Foundation . WALKER WALKS IT BACK — Georgia Republican Senate candidate Herschel Walker softened his stance on abortion in his first debate with Sen. Raphael Warnock on Friday, POLITICO's Natalie Allison reports. More than a week after being accused of encouraging and paying for an ex-girlfriend's 2009 abortion, the candidate said he is still "pro-life" and criticized the incumbent for supporting abortion rights. But he said he agrees with Georgia's law that allows exceptions for rape, incest and the mother's life while prohibiting abortion after six weeks, a position that differs from his remarks earlier this year.   STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what's next in health care? Sign up for our Future Pulse newsletter. If you aren't already subscribed, follow this link to start receiving Future Pulse .     Names in the News Sarah Newman Boateng is now acting principal deputy assistant secretary in the office of the assistant secretary of health at the Department of Health and Human Services. She most recently was chief of staff for that office. Charlene MacDonald will be chief government affairs officer at CareFirst BlueCross BlueShield. She most recently served as senior managing director and head of health care and life sciences at FTI Consulting. What We're Reading The New York Times reports on the journey of surrogate mothers during Ukraine's war. A new study shows female doctors are twice as likely as their male counterparts to be called by their first names, NPR reports . Floodlight and the Texas Tribune investigate why Texas won't fix the old oil and gas wells contaminating its land and water.   A message from PhRMA: The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole. The program of today is having the opposite effect of what Congress intended when they created 340B. That's a problem. It's time to fix the 340B program. Learn more.     Follow us on Twitter Tucker Doherty @tucker_doherty Dan Goldberg @dancgoldberg Erin Banco @ErinBanco Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Ben Leonard @_BenLeonard_ David Lim @davidalim Krista Mahr @kristamahr Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Megan R. Wilson @misswilson Daniel Payne @_daniel_payne Ruth Reader @RuthReader   Follow us

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