FDA, industry take stock of medical supply chain post Hurricane Fiona

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Sep 20, 2022 View in browser   By David Lim, Katherine Ellen Foley and Lauren Gardner Presented by Genentech On Tap — The FDA is keeping a close eye on the medical supply chain after Hurricane Fiona knocked out power to most of Puerto Rico. — Negotiations over legislation to reauthorize the FDA's user fee programs continue into this week. — Members of the external review of the FDA's tobacco program will likely be revealed this week . It's Tuesday. Welcome to Prescription Pulse. The top HHS spokesperson noted Monday that the Covid-19 Public Health Emergency remains in effect. 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 Genentech: The COVID-19 pandemic has highlighted the urgent need to improve our country's response to a public health crisis. Learn more about the five critical actions Genentech believes we can take now to build on the learnings from the pandemic to develop solutions and better prepare for the future.   Industry Intel Some medical industry companies in Puerto Rico are confident that Hurricane Maria won't affect supply chains. | Stephanie Rojas/AP Photo MEDICAL INDUSTRY CAUTIOUSLY OPTIMISTIC AFTER HURRICANE FIONA — Nearly five years after Hurricane Maria devastated Puerto Rico, at least one critical medical product company — Baxter — says it has weathered Hurricane Fiona with little to no damage to its facilities. "It seems that many of the suppliers did take the lessons learned from Hurricane Maria and diversified their supply chains," said Soumi Saha, senior vice president of government affairs for group-purchasing organization Premier. "The next 24 to 72 hours will be critical to confirm that." Baxter, one of the largest IV bag manufacturers, said it has accounted for all its employees and expected to reopen its facilities last night using generator power. "We are optimistic about our ability to return to normal operations in Puerto Rico and the Dominican Republic in the coming days," Baxter spokesperson Lauren Russ told POLITICO in an email. "Our ability to restart operations is dependent on roads and bridges being accessible and employees being able to return to work."  But the storm's true impact could take days to become evident, some caution — nearly the entire island lost power amid torrential rain from Hurricane Fiona. "It's too soon to say," American Hospital Association spokesperson Ben Teicher said. "We'll learn more throughout the next few days as damage assessments continue and reports from FEMA/HHS come out." The FDA told POLITICO it is "actively monitoring" the situation and working with facilities in Puerto Rico. "The agency will provide further information as it learns more and will use all of the tools at its disposal to mitigate and prevent any potential disruptions or delays in product supply," an FDA spokesperson said in a statement. In Congress Despite negotiations over the weekend, the House Energy & Commerce Committee and the Senate HELP Committee can't agree on riders to FDA user free programs. | Energy and Commerce Committee/Facebook | Energy and Commerce Committee/Facebook SURPRISE! USER FEES TALKS CONTINUE — Negotiations between the leaders of the Senate HELP Committee and the House Energy and Commerce Committee on a package to reauthorize the FDA's user fee programs for drugs and medical devices continued over the weekend, but no resolution was reached. Negotiations are centered on approximately 15 to 20 riders to the base reauthorization, according to five industry lobbyists and congressional aides granted anonymity to discuss the ongoing talks. "It makes it hard to really trade [riders], because it almost looks like it's easier to say, 'let's do none,' if you've got the leadership-level Republicans off committee — the ones doing the macro-level [continuing resolution] discussion — trying to clamp down," one of the industry lobbyists said. GOP MEMBERS PRESS FDA ON TOBACCO POLICY — Reps. Brett Guthrie (R-Ky.) and Morgan Griffith (R-Va.), senior members of the E&C Committee, pressed FDA Commissioner Robert Califf on Monday for a detailed accounting of how the agency spends user fees that fund the Center for Tobacco Products and how other regulatory priorities might be affecting its consideration of product applications. The members expressed concern with the FDA's plans to ban menthol cigarettes and flavored cigars when regulators already take years to make decisions on premarket product applications that are legally supposed to happen within six months. The Republicans noted in the letter that their questions may be addressed in part by an external review of the FDA's food and tobacco regulatory arms (more on that below). But they reminded Califf he'll "still be responsible for addressing these issues within FDA and answering to Congress" for his decisions, signaling the oversight to come if Republicans take control of the House next year. E&C TO MARK UP VACCINE INJURY BILL — The committee will mark up several bills Wednesday, including one, H.R. 3655, to update the Vaccine Injury Compensation Program.   JOIN THURSDAY FOR A GLOBAL INSIDER INTERVIEW : From climate change to public health emergencies and a gloomy global economic outlook, the world continues to deal with overlapping crises. How do we best confront all of these issues? Join POLITICO Live on Thursday, Sept. 22 at 10:30 a.m. EDT for a virtual conversation with Global Insider author Ryan Heath, featuring World Bank President David Malpass, to explore what it will take to restore global stability and avoid a prolonged recession. REGISTER HERE.     Eye on the FDA EXTERNAL REVIEW BEGINS SOLICITING ANONYMOUS INPUT ON FOOD PROGRAMS — The Reagan-Udall Foundation, the group tasked with reviewing the FDA's food safety and tobacco programs, opened up a public portal for anonymous feedback on the FDA's food safety program on Monday. "We want to hear firsthand observations about both the strengths and challenges the program faces as well as ideas on how to best prepare for the regulatory landscape of the future," Jane Henney, the former FDA commissioner in charge of the food review, said in a statement. The foundation also announced it would hold public meetings on Sept. 29 and 30 in downtown D.C. about the agency's food safety programs, nutrition programs and resources and its relationships with states and other agencies. The meetings will feature Henney and her five-member independent expert panel, each of whom have experience working either directly with federal agencies or as advisers to them, as well as getting input from consumers, scientists and other federal officials. The Reagan-Udall Foundation also said it will send its external report on the food safety program to Califf on Dec. 6. On the tobacco side: The panel members who will review the tobacco programs will likely be announced later this week, a person familiar with the matter not authorized to speak told Katherine. "The tobacco review will be more limited compared to food [safety]," the person said, pointing out that the food safety program encompasses several long-standing offices within the FDA, the Department of Agriculture and state inspection programs. The Center for Tobacco Products, meanwhile, is a single, 13-year-old office.   A message from Genentech:   Industry Intel FDA APPROVES GENE THERAPY FOR RARE NEUROLOGICAL DISEASE — Skysona, a gene therapy from Bluebird Bio, received accelerated approval from the FDA on Friday to slow the progression of active cerebral adrenoleukodystrophy, a rare, fatal neurodegenerative condition that affects young boys. Back in June, the FDA's advisory committee on cellular, tissue and gene therapies voted 15-0 to recommend the drug's approval. The day before the FDA approved Skysona, the agency lifted a clinical hold enacted because a patient in a clinical trial developed a rare blood cancer after receiving treatment; two more patients have since developed the condition. $$$: Bluebird is pricing the drug at $3 million, beating its own record for the most expensive single-use treatment, which it set in August for its $2.8 million approved gene therapy targeting the blood disorder beta thalassemia.   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.     Quick Hits Pfizer was sued in a federal court last week by a Virginia-based group that alleged the company's fellowship program illegally excludes applicants who are white and Asian American from the program, which is intended to increase diversity at the drugmaker, Reuters' Jonathan Stempel reports.   Pharma Moves Drug pricing group Patients For Affordable Drugs has named Merith Basey as its new executive director. Document Drawer The White House Office of Information and Regulatory Affairs began a review of draft guidance late last week that updates recommendations for the FDA's breakthrough devices program. The notice indicates the recommended updates aimed to reduce disparities in health care. Califf announced Monday that outside experts associated with Ohio State University would conduct an external review of the FDA's approach to regulating opioids.   A message from Genentech: As we begin to ease back into a "new normal," we must not lose sight of the reality that the COVID-19 pandemic is not yet behind us, and unfortunately, the next pandemic could be just around the corner. If history has taught us anything, it's that science, when fueled by collaboration, is our strongest weapon against life-threatening disease. We currently have a vital window of opportunity to learn and take action so that our nation is in a less vulnerable position before the next public health crisis. Learn more about what Genentech believes are the five most critical steps we must take to better prepare for the future.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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