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Presented by SimpliSafe: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Katherine Ellen Foley, Lauren Gardner and David Lim | Presented by SimpliSafe | With Emily Martin | | | — The Biden administration wants to overhaul the U.S. generic drug industry’s supply chain, but it won’t be cheap. — The FDA’s drug center now has a deputy leader. — FDA leaders continue to make the rounds touting the benefits of Covid vaccines compared to the risks of side effects like myocarditis. It’s WEDNESDAY, welcome back to Prescription Pulse. One of your hosts is not thrilled with the return of the summer cold. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley). | | | | A message from SimpliSafe: Most security companies send a technician to your home. SimpliSafe doesn’t. Order online. Set it up in 30 minutes. After that, you’re protected 24/7. Learn more. | | | | | | LAWMAKER INTEREST IN PHARMA SUPPLY CHAIN OVERHAUL STALLS — The Biden administration is pushing for more essential medicines to be made in the United States — but it’s not clear whether there’s enough political momentum, or enough money, to make it happen. The problem: Regulatory and industry experts have known for years that the drug supply chain is fragile and opaque, but the Covid-19 pandemic brought it into the spotlight. Twenty-nine of 40 critical drugs for treating Covid-19 patients were in shortage at various points in 2020, including common painkillers, the asthma drug albuterol and medicines used to sedate patients on ventilators, according to a report released in October by the Center for Infectious Disease Research and Policy at the University of Minnesota. Bringing drug production to the U.S. In an effort to shore up the U.S. generic drug supply chain, the Biden administration has announced plans to create a public-private partnership to identify and increase domestic production of 50 to 100 essential generic drugs. It also announced $60 million in initial funding for HHS in this spring's pandemic relief package to develop new ways to make drugs domestically. Realistically, it will take billions of federal spending on research investments, reimbursement updates and regulatory overhauls to lure stable generic drug manufacturing back to U.S. soil. Despite bipartisan support for the idea in Congress, that price tag is making some lawmakers balk — especially after two years of significant pandemic relief spending. “[Republicans] are getting spending fatigue,” a Democratic Senate staffer said. “They have a feeling of 'well we've invested through the American Rescue Plan,’” and that’s enough, the aide said, referring to the $1.9 trillion coronavirus relief package enacted in March. | | | | SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today. | | | | | | | | CAVAZZONI NAMES PRINCIPAL DEPUTY — CDER Director Patrizia Cavazzoni announced Tuesday that Jacqueline Corrigan-Curay is stepping into a new role at FDA as the principal deputy center director of CDER. M. Khair ElZarrad will serve as acting director of FDA’s Office of Medical Policy, which Corrigan-Curay previously led. “Jacqueline brings to the position a unique legal, scientific, policy, and clinical background,” Cavazzoni wrote in an email to CDER staff, noting her work on “implementing medical policy programs and strategic initiatives for real-world evidence, drug labeling, prescription drug promotion, clinical trial oversight, and innovative trial design.” FDA LEADERS SEEK TO ALLAY MYOCARDITIS FEARS — Top FDA officials are stressing that the risks of getting Covid-19 and having serious complications are much greater than the risk of developing myocarditis, a heart inflammation condition, after receiving a Covid vaccine. “If it were my kid, I’d be the first in line with them” to ensure they get vaccinated, acting FDA Commission Janet Woodcock said. Woodcock and Center for Biologics Evaluation and Research Director Peter Marks held a stakeholder call last week to answer questions about the possible links between myocarditis in young people and vaccines. A different approach to a potential side effect: Marks spelled out why health officials have taken a different approach to addressing those myocarditis cases, which tend to present in males under 30, compared to the blood-clotting condition linked to the Johnson & Johnson shot in April that prompted a 10-day “pause” on its administration. Myocarditis is already a “known phenomenon” among youths aged 12 to 17, he said, and the rate of cases seen in vaccinated children appears to be about five times greater than the baseline. But when it comes to the J&J clotting issue, he said, the chances of developing it absent vaccination are “vanishingly small.” “You don’t know whether it’s just cases that would’ve been there that aren’t really associated with the vaccine that have come up, or how much actually the vaccine has increased that risk” of heart inflammation, said Marks, who added that he wasn’t denying that the vaccines could be behind the increase. “We talk about [side effects like myocarditis] because we’re trying to be transparent, but the chance that they’re going to occur is very, very low,” he said, adding that the recorded cases have been mild. | | | FDA FINALIZES GUIDANCE ON UNIQUE DEVICE IDENTIFIER LABELING — FDA on Tuesday published recommendations outlining how device manufacturers should comply with unique device identifier labeling requirements. | | | |   | | | | | | FDA BACKS EXPANDED USE FOR KEYTRUDA — Regulators signed off on an expanded label for Merck’s cancer biologic Keytruda, the company announced Tuesday. The drug is now approved for patients with locally advanced cutaneous squamous cell carcinoma that can’t be cured by radiation or surgery. | | | BIDEN TAPS SESHAMANI TO HEAD MEDICARE OFFICE — Meena Seshamani, a doctor and Obama-era health official, will oversee the program that insures 61 million American seniors and others with disabilities, POLITICO’s Adam Cancryn writes. She will also be a deputy administrator at CMS. | | | | TUNE IN TO DISPATCH+ ON APPLE PODCASTS : POLITICO Dispatch, our daily podcast that cuts through the news clutter and keeps you up to speed on the most important developments of the moment, is expanding. In collaboration with the new Apple Podcasts Subscription platform, Dispatch+ launches this week! This new podcast gives premium Dispatch+ s exclusive bonus weekly reporting and analysis from POLITICO's newsroom. Don't miss out, subscribe and listen to Dispatch+ on Apple Podcasts. | | | | | | | | AFRICA RUNS LOW ON JABS AS EUROPE BUYS UP BOOSTER SHOTS — As countries like the U.K. and Germany negotiate deals for what could be hundreds of millions of extra jabs to give citizens third doses, Africa is running low, POLITICO EU’s Ashleigh Furlong reports. With more transmissible variants spreading and uncertainty growing about how long immunity will last, European countries have begun in earnest to buy additional vaccines for their populations. Meanwhile, shipments to Africa of AstraZeneca doses from COVAX coming through the Serum Institute of India have dried up. ENGLAND ENDS REQUIRED QUARANTINE FOR VACCINATED ADULTS — U.K. Health Secretary Sajid Javid said fully vaccinated adults will no longer need to self-isolate if they have contact with someone who tests positive for Covid-19 as of August 16, POLITICO EU’s Annabelle Dickson reports. Under-18s will also be exempt from the current rules, which require those who have come into close contact with someone who later tests positive for the virus to stay at home for 10 days. Contacts will still be asked to take a PCR test as soon as possible. | | | E-cigarette giant Juul is pouring its remaining resources into its fight to remain on the market, Sheila Kaplan reports for The New York Times. As business took a nosedive globally, numerous health organizations have asked the FDA to reject the “iPhone of e-cigarettes” as the agency reviews its premarket tobacco product application. | | | | A message from SimpliSafe: It’s finally easy to make sure your house is safe. Whatever you’re worried about—from french doors to basement windows—SimpliSafe’s got your back. Just click here to customize your system and get a FREE security camera. | | | | | | Woodcock on Tuesday outlined in a blog post how FDA plans to spend additional funds it requested from Congress on IT investments and other priorities. FDA handed out warning letters to several firms on Tuesday over masks that were allegedly marketed without approval, clearance or authorization. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
