Califf lays out his FDA priorities

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Feb 18, 2022 View in browser   By Ben Leonard Presented by With help from Megan R. Wilson, Megan Messerly and Alice Miranda Ollstein Programming Note: We'll be off this Monday for Presidents Day but will be back in your inboxes on Tuesday, Feb. 22. Editor's Note:  POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day's biggest stories. Act on the news with POLITICO Pro. QUICK FIX — New FDA commissioner Robert Califf laid out priorities for the agency after being sworn in Thursday. —  The FTC voted against probing the role of pharmacy benefit managers in a split vote. — California Gov. Gavin Newsom rolls out his "next phase" Covid-19 plan as some blue states ease pandemic restrictions. WELCOME TO FRIDAY PULSE — I'm still shocked that a bunny got into the Pentagon. Send your theories of the case and tips to bleonard@politico.com.   A message from PhRMA: Washington is talking about price setting of medicines, but it won't stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let's cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let's protect patients. It's the right choice. Learn more.   Driving the Day CALIFF FDA PRIORITIES — New FDA commissioner Robert Califf was sworn in Thursday to lead the agency where he'll face a number of challenges. My POLITICO colleagues this week laid out six key issuesfor Califf, including what will happen to tests and treatments under emergency authorization once the public health emergency expires, as well as matters surrounding user fees, opioids, abortion pills and tobacco regulation. Califf, confirmed by a 50-46 vote Tuesday for his second go-around atop the agency, unveiled his priorities Thursday in a tweet thread from his new Twitter account. With misinformation about Covid-19 running rampant, Califf said it would be key to push back against misinformation about science and the agency. "These kinds of distortions and half-truths that find their way into the public domain do enormous harm, both by leading people to behavior that is detrimental to their health," Califf wrote. Some other priorities he cited included: — The Covid-19 pandemic response  —Accelerating development of new treatments and devices — Lessening harm from tobacco and stopping young people from using "harmful tobacco products, including e-cigarettes" "At the core of all of these issues is the fundamental need to enhance our ability to collect and analyze data," Califf said. FTC PUNTS ON PBM PROBE — The Federal Trade Commission deadlocked in a 2-2 party-line vote Thursday about whether to probe the business practices of pharmacy benefit managers, or PBMs, a move that sends the commissioners back to the drawing board, POLITICO's Leah Nylen and Megan R. Wilson report. Republican commissioners on the panel voted against a study because they said that, as drafted, it wouldn't t consider key concerns, such as the impact of PBMs on out-of-pocket costs for consumers, but indicated they wanted to work with Chair Lina Khan to get a study "across the finish line." Kahn said she was "disappointed by this outcome," calling it a "life-or-death" situation. Voting for the review wouldn't have launched a law enforcement action; instead it would have approved the development of a study from which information could be used to open investigations into certain companies. B. Douglas Hoey, CEO of the National Community Pharmacists Association, said in an emailed statement that "two members of the FTC just let the worst actors in the market off the hook." The largest players in the PBM space — CVS Caremark, Express Scripts and OptumRX — represent nearly 80 percent of the market and are either owned by or own insurance companies. The trio also represents three of the four largest U.S. pharmacies by prescription drug revenue. In a statement after the vote, the Pharmaceutical Care Management Association — which represents PBMs — pointed the finger at drugmakers for high prescription prices. "PBMs are holding drug companies accountable by relentlessly negotiating the lowest possible cost on behalf of patients, and are driving and delivering local competition that patients are demanding," Greg Lopes, a spokesperson for the group, said in an emailed statement. NEWSOM STRATEGY —  California Gov. Gavin Newsom laid out a strategy Thursday for the "next phase" of tackling Covid-19 in the state, a plan focused on detecting variants early, bolstering high-quality mask supply and obtaining rapid tests, POLITICO's Victoria Colliver reports. A 30-page document detailing the approach doesn't include the word "endemic." The plan's goals are to "keep schools open and children safely in classrooms." The effort doesn't have metrics or goals to trigger certain approaches but has levers to pull when variants or surges arise. "We're announcing what I like to call response metrics that, if we need them, these are going to be what keeps us ready for the future," California's Health and Human Services Agency Secretary Mark Ghaly said. Backdrop: California is among several Democratic-controlled states rethinking their approach to the pandemic and rolling back precautions as Omicron cases sharply decline. The CDC is also weighing updating its metrics guidelines, which states should look to when lifting public health measures like mask mandates. On the Hill CONGRESS TEES UP POST-RECESS VOTES ON INSULIN, ABORTION — Senate Majority Leader Chuck Schumer filed cloture Thursday night on bills to cap out-of-pocket costs for insulin and bar states from implementing abortion bans, POLITICO's Alice Miranda Ollstein reports. The move sets up two high-profile votes for when Congress returns after a week of recess. One is a standalone bill by Sen. Raphael Warnock (D-Ga.) to advance one of the most popular provisions of Democrats' now-sidelined social spending bill: a $35 a month cap on out-of-pocket costs for insulin products. Unlike other Democratic health policy goals, this has the potential to win GOP votes and could provide a crucial boost for Warnock heading into a tough reelection this November. The other, the Women's Health Protection Act, S. 1975 (117) , would ban states from implementing many types of abortion restrictions and secure access to the procedure as the Supreme Court is poised to roll back a decades-old precedent. While the passed the House in October, it has nowhere near the 60 votes it needs to pass the Senate, but many Democrats say it's worth putting members on the spot heading into the midterms. WARREN CALLS ON BECERRA TO 'MARCH IN ' ON CANCER DRUG — Sen. Elizabeth Warren urged HHS Secretary Xavier Becerra in a letter Friday to hear and grant a "march-in rights" petition to cut the price of Xtandi, a prostate cancer drug. The Massachusetts Democrat, alongside Sen. Angus King (I-Maine) and Rep. Lloyd Doggett (D-Texas), argues executive action is warranted because federal grants underwrote the patented technology's research. Research Corner NEW STUDY ON ABORTION PILLS FINDS LOW COMPLICATION RATE — New research on the safety and effectiveness of abortion pills, published online in The Lancet on Thursday, reported that more than 96 percent of medication abortions are successful and 1 percent of patients sought treatment for a "serious adverse event" after taking the drugs, Alice reports. The peer-reviewed study, led by University of Texas at Austin professor Abigail Aiken, comes on the heels of the FDA's decision to permanently loosen restrictions on abortion pills and allow people to obtain them via telemedicine and by mail and as a wave of GOP states advance bills to limit their access or ban them entirely. The study looked at nearly 3,000 "self-managed" medication abortions with pills obtained online that took place in 2018 and 2019. Of those: — 96.4 percent reported successfully ending their pregnancy without follow-up surgery. — Of the 1 percent that reported treatment of a serious adverse event, 0.6 percent reported receiving a blood transfusion, while 0.5 percent reported receiving intravenous antibiotics. — No deaths were reported. "In light of increasingly restricted access to in-clinic abortion in the U.S., it may offer a safe and effective option for those who cannot access clinical care," the study's authors said of medication abortion.   A message from PhRMA:   RECALL FDA ANNOUNCES MAJOR INFANT FORMULA RECALL — The FDA late Thursday warned consumers not to use certain powdered infant formulas produced from Abbott Nutrition's Sturgis, Michigan, facility — a plant that makes major brands of formula, including Similac, Alimentum and EleCare — after four babies were hospitalized for Cronobacter and one for Salmonella, POLITICO's Helena Bottemiller Evich reports. One infant has died. The agency said the investigation is ongoing, and it has initiated an onsite inspection where it found "several positive Cronobacter sakazakii results from environmental samples taken." Around the Nation BIRD FLU — Federal officials are trying to get their hands around bird flu outbreaks across Indiana, Kentucky and Virginia. Tens of thousands of chickens and turkeys have been infected. A senior Agriculture Department official tells POLITICO's Meredith Lee the situation is of "significant concern" for the poultry sector because the disease can so quickly spread through bird populations. The USDA says the risk to humans is low and notes there haven't been any reported human infections. Medicaid MEDICAID CONTINUOUS COVERAGE — Health care organizations representing state Medicaid directors, long-term care facilities, insurance companies, safety net health plans, children's hospitals, community health centers and behavioral health providers are joining Medicaid managed care plans in calling on Congressional leaders to give them 120 days' notice before a provision barring states from kicking people off state Medicaid rolls during the public health emergency, Megan Messerly reports. Sudden termination of the Medicaid continuous coverage requirement, the groups warned in a Thursday letter, "could lead to dangerous and unnecessary gaps in coverage and care." Medicaid Health Plans of America penned a similar letter to congressional leaders last week. The request from industry leaders comes as it appears the public health emergency, to which the Medicaid continuous coverage provision is currently tied, will be extended from April 15 until July. The Biden administration promised a 60-day warning before the PHE is terminated, a deadline that came and went on Tuesday. What We're Reading The Biden administration is "surg[ing]" more than a quarter of a billion dollars in Covid-19 vaccine aid to countries in sub-Saharan Africa, The Washington Post's Dan Diamond and Emily Rauhala report. The Baltimore Sun's Meredith Cohn has this headline : "With 'bodies piling up,' contractors clearing backlog at Maryland medical examiner's office for $850 an autopsy." Booster uptake is at its lowest rate yet, Jacqueline Howard reports for CNN.   A message from PhRMA: Washington is talking about price setting of medicines, but it won't stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let's cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let's protect patients. It's the right choice. 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_ Rachael Levy @rachael_levy David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Sarah Owermohle @owermohle Carmen Paun @carmenpaun Darius Tahir @dariustahir Megan R. Wilson @misswilson   Follow us

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