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Presented by Emergent BioSolutions: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by Emergent BioSolutions | PROGRAMMING NOTE: Prescription Pulse won’t publish from Dec. 24 to Dec. 31. We’ll be back on our normal schedule on Tuesday, Jan. 4. | | | — The Centers for Disease Control and Prevention now recommends the Pfizer and Moderna mRNA vaccines over the Johnson & Johnson shot. — FDA to loosen longstanding rules on how abortion pills may be distributed. — Robert Califf appears likely to be confirmed to another stint atop the FDA — but with GOP help. It’s Friday. Welcome back to Prescription Pulse. Despite the unseasonably warm weather, we hope D.C.’s dazzling Christmas trees put you in the holiday spirit. 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). | | | | A message from Emergent BioSolutions: Emergent has produced over 100 million Covid-19 vaccine dose-equivalents. Today, these critically important doses are deployed around the world to help fight the pandemic. Get the latest on Emergent’s Covid-19 response. | | | | | | CDC ADVISERS: mRNA VACCINES ‘PREFERRED’ OVER J&J — External advisers to the CDC voted unanimously Thursday afternoon to recommend the Pfizer and Moderna vaccines over Johnson & Johnson’s after new data showed the overall rate of a rare but serious blood-clotting condition associated with the single-dose shot is higher than previously known. CDC Director Rochelle Walensky endorsed the change hours later. Regulators first paused administration of the J&J vaccine in April after six cases of the condition, known as TTS, were identified. While the incidence rate is still highest among women ages 30 to 49, data collected over the last year shows that men and women of all ages have varying levels of risk — and that the proportion of fatal cases hasn’t fallen since the pause. Of the 17 million J&J doses administered in the U.S., nine people have died from TTS post-vaccination. But that number represents 15 percent of all the clotting cases identified after inoculation. In a country with ample mRNA vaccine supply (which, of course, has its own side-effect controversy, though vaccine-induced myocarditis has yet to prove fatal), health officials want to make it clear to Americans that the Pfizer and Moderna shots have a far better benefit-risk profile. Why not limit it entirely? Some advisory committee members signaled they were inclined to more explicitly limit the J&J product’s use, whether it be a full recommendation against it or a restriction of its use in certain populations. But the prospect of no single-dose option — putting aside the debate over whether the shot should be considered a two-dose series — raises equity issues both domestically and abroad. Some people can’t or won’t return for a second dose, some still don’t trust the mRNA technology, others are allergic to components of the Pfizer and Moderna shots. And some places only have the J&J shot as an option for their citizens, meaning a fulsome recommendation against it could further stymie vaccine confidence. SIDE EFFECT REPORTS COME IN FOR KIDS WHO GOT PFIZER SHOT — The advisory committee also heard the latest data on adverse events reported in children ages 5 to 11 who received the Pfizer vaccine. So far, eight cases of myocarditis have been verified in kids post-immunization, with most occurring within three days of the second dose. The vast majority of reports to federal vaccine side effect registries were not serious, with the most common problems being incorrect dosage, vomiting and fever. Two deaths have been reported within days of vaccination, but they’re still being reviewed. Both cases involved young girls with several serious underlying conditions. HHS OMICRON MODEL PREDICTS STRAINED TESTING SYSTEM — Biden administration health officials are privately warning Covid-19 test makers and laboratories that demand for tests could double or even triple over the next two months as cases surge across the country, five people with knowledge of the matter told POLITICO. That possibility has fueled concern among Biden officials about whether the manufacturing of lab-based PCR, professional point-of-care and at-home tests will be able to keep pace with a sudden rush in demand. BIDEN LAUDS PFIZER COVID PILL AMID FDA REVIEW — President Joe Biden on Tuesday released a statement saying he is “encouraged by the promising data” released by Pfizer on its antiviral pill for Covid-19 amid FDA’s review of the treatment. Biden acknowledged the agency still needs to authorize the pill but touted a purchase order the government already made — enough for 10 million people. | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | FDA EASES RULES AROUND ABORTION PILL DISTRIBUTION — FDA announced Thursday it is lifting long-standing restrictions on abortion pills, clearing the way for doctors to prescribe the drugs online and have them mailed to patients or sent to local pharmacies, POLITICO’s Alice Miranda Ollstein reports. FDA reviewed mifepristone — one of two drugs used to end a pregnancy in the first 10 weeks — because of several lawsuits, including one filed in 2017 that challenged the regulations and argued the pills are just as safe whether distributed in person or by mail. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a letter to the ACLU on Thursday the review of the drug’s safety data found that the restrictions “must be modified to minimize the burden on the healthcare delivery system.” But the agency argued for maintaining some restrictions the group had challenged, arguing that physicians prescribing the drugs need to “have the ability to date pregnancies accurately and to diagnose ectopic pregnancies” and “be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care” if a complication arises. FDA also preserved previous administrations’ warnings against buying the pills online, telling patients Thursday that doing so will “bypass important safeguards designed to protect your health.” Online pharmacies that source the pills from overseas are popular with activist groups working on getting the drugs to people in states that may move to ban them. | | | BIDEN’S FDA PICK ON TRACK FOR CONFIRMATION WITH GOP HELP — Several Senate HELP Committee Republicans — including Sens. Richard Burr of North Carolina, Susan Collins of Maine, Tommy Tuberville of Alabama and Roger Marshall of Kansas — told your authors following Robert Califf’s confirmation hearing Tuesday they’ll back him to lead FDA. Their support would likely push Califf through a committee vote and, later, a full Senate vote on the nomination. Dems pressed Califf on several policy issues and some made it clear their support wasn't a given. — Opioids: Sen. Maggie Hassan (D-N.H.) blasted Califf for what she sees as FDA’s reckless labeling of prescription opioids, leading to the opioid addiction crisis.
— Drug pricing: Sen. Bernie Sanders (I-Vt.) grilled Califf on his ties to industry and whether he would support Medicare negotiating drug prices. He later said he wouldn’t support Califf’s nomination.
— Participant diversity in clinical trials: Sen. Tina Smith (D-Minn.) questioned how Califf plans to include more pregnant individuals in clinical trials.
—E-cigarette regulation: Sen. Tammy Baldwin (D-Wis.) asked Califf how he would crack down on vape companies using synthetic nicotine to skirt FDA’s regulation. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | MEDTRONIC HIT WITH WARNING LETTER — Medtronic disclosed Wednesday that FDA issued a warning letter on Dec. 9 to the company regarding its diabetes headquarters in Northridge, Calif. It was issued following a July 2021 inspection tied to recalls of its MiniMed 600 series insulin infusion pump, as well as a remote controller for its MiniMed 508 and Paradigm pumps. “The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events,” Medtronic said in a press release. FDA has not yet published the warning letter on its website. FDA LEADER TALKS MED DEVICE CYBERSECURITY — Medical device cybersecurity is sorely lacking, FDA’s medical device cybersecurity leader Kevin Fu said in a Q&A with POLITICO’s Ben Leonard. The consequences of the attacks are only getting worse as dependency on computing grows, Fu said. It’s unclear whether there are enough incentives for device makers to tackle cybersecurity properly, he said, and that preparedness varies significantly across the industry. | | | |   | | | | | | NIH-FUNDED SURVEY SEES A DROP IN YOUTH VAPING IN 2021 — Vaping rates across middle- and high-school students dropped between 2020 and 2021, the Monitoring the Future survey found . The survey, which is conducted by the University of Michigan, Ann Arbor, found that in 2021, 12.1 percent of eighth graders reported vaping at all in the past year, as did 19.5 percent of tenth graders and 26.6 percent of twelfth graders. In 2020, those figures were 16.6 percent, 30.7 percent and 34.5 percent, respectively. What happened? It’s hard to say what factors specifically lowered vaping rates among teens, though some experts hypothesize this decline could partially be a result of students attending school from home, where e-cigarettes — and peer pressure — aren’t as available. A note on Juul: Juul pod use specifically among teens fell faster than overall nicotine vaping rates. Eighth-grade Juul use in the past year fell from 12.8 percent to 6.2 percent, tenth-grade rates fell from 23.3 percent to 9.2 and twelfth-grade rates fell from 26.1 percent to 12.2 percent. “Over the past several years, we reset our company,” said Juul’s chief regulatory officer, Joe Murillo in a statement. “While millions of adult smokers have converted to our products from cigarettes, we will only be trusted to provide alternatives to adult smokers if we continue to combat underage use.” Anti-youth vaping groups remained concerned: “ With kids now back in school, we face the real risk of a resurgence in youth e-cigarette use,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids, in a statement, adding that he’d like to see FDA eliminate flavored vapes entirely. HOUSE LAWMAKERS INTRODUCE BILL TO ELIMINATE SYNTHETIC NICOTINE LOOPHOLE — Rep. Raja Krishnamoorthi (D-Ill.) Rep. Chris Stewart (R-Utah) and Rep. Mikie Sherrill (D-N.J.) introduced legislation that would give FDA clear authority over synthetic nicotine. Currently, the agency only has explicit authority over tobacco-derived nicotine — a fact some e-cigarette companies, including Puff Bar, have used to continue selling flavored e-cigarettes. | | | BIOGEN LAYS OUT PLANS FOR FOLLOW-UP STUDY OF ADUHELM — Biogen on Thursday said it will begin screening participants for clinical research next May to prove that its $56,000-a-year Alzheimer’s therapy helps patients more than a placebo, Katherine reports. FDA required this postmarketing trial as part of its conditional approval for Aduhelm. | | | Myriad Genetics announced Tuesday Nicole Lambert is being promoted to be the company’s chief operating officer. She previously was in charge of Myriad’s oncology, women’s health and international business units, as well as its genetic testing laboratory operations. Sanofi announced Wednesday its board of directors appointed Gilles Schnepp as chair of the Appointments, Governance and CSR Committee. He will step down from his current position on the company’s Audit Committee. | | | ILLUMINA SLAMS EU — Illumina labeled EU competition chief Margrethe Vestager’s approach to the U.S. gene-sequencing giant’s Grail takeover as “bizarre” and “plainly unfair” in an EU court hearing on Thursday, POLITICO EU’s Pietro Lombardi reports. Vestager is examining the deal for the U.S. cancer-test startup under Article 22 of the EU merger regulation, which allows the European Commission to look into deals with significant competition risks even if they don’t meet traditional thresholds for review. | | | Two former FDA officials blasted the Biden administration in a Washington Post op-ed Thursday for not convening outside advisory committees before making significant vaccine decisions, arguing such actions degrade public trust in public health agencies. | | | | A message from Emergent BioSolutions: At Emergent, we develop, manufacture, and deliver protections against public health threats. Find out how we’ve enhanced and reinforced quality control and oversight practices on our vaccine bulk drug substance manufacturing in support of Covid-19 vaccine production. | | | | | | The Government Accountability Office released a report Thursday on how federal agencies are trying to improve use of Defense Production Act powers in the future. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
