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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner and David Lim | | | | — The FDA wants to hire an experienced media messenger to help manage its public relations strategy. — Advocates say an FDA meeting examining the accuracy of pulse oximeters in people of color should have come faster. — A WHO program designed to fast-track Covid vaccines and drugs to low-income nations is expected to wind down this fall. It’s Wednesday. Welcome to Prescription Pulse. Are you Senate HELP Committee Chair Patty Murray’s chief of staff MINDI LINQUIST? We want to hear from you. 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).
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Vin Gupta is considered to be a top contender to become the FDA's principal medical adviser and public messenger. | Halsey Pierce | FDA LOOKS TO TAP SKILLED MESSENGER AMID PR MISSTEPS — The FDA is eyeing a media-savvy public health expert to guide its public relations strategy after a series of flubs on abortion access post-Roe, the infant formula shortage and the pandemic, POLITICO’s Adam Cancryn scoops. Vin Gupta, a pulmonologist and frequent guest on NBC and MSNBC, is the top contender to become the agency’s principal medical adviser and is expected to become its public face on high-profile policy issues. How we got here: The move comes as some within the Biden administration believe Commissioner Robert Califf needs high-level help with communicating about several politically sensitive topics. For instance, it took the FDA hours to issue a statement responding to the Supreme Court decision overturning Roe v. Wade — well after non-health-related federal departments issued on-the-record quotes — a sluggish reaction that may well be rooted in the agency’s desire to avoid appearing as if it’s politicizing science. Califf’s efforts to explain the FDA’s slow response to the infant formula crisis have won him few allies on Capitol Hill. And the agency has taken public hits for its review of Covid-19 vaccines for babies and toddlers, which became available last month despite federal officials signaling last year that they were likely to debut in the wintertime. Job description: Gupta’s main duties would be improving the FDA’s image, bolstering public trust in the agency and serving as a top adviser to Califf, who’s called combating misinformation one of his primary goals as commissioner. ANOTHER AMYLYX ADCOM — Amylyx Pharmaceuticals said Tuesday that the FDA will reconvene its Peripheral and Central Nervous System Drugs Advisory Committee on Sept. 7 to examine new data for AMX0035, the company’s amyotrophic lateral sclerosis candidate drug. “Discussions will focus on the additional analyses of data from the Company’s clinical studies that were determined by the FDA to constitute a major amendment to the [New Drug Application],” Amylyx said in a press release. The outside advises previously discussed the NDA on March 30. The drug’s new Prescription Drug User Fee Act target date is Sept. 29.
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | FLAWED PULSE OXIMETER READINGS AND COVID’S UNEVEN TOLL — A forthcoming FDA meeting to examine the performance and accuracy of pulse oximeters has not come fast enough, according to patient advocates who argue weak regulatory oversight has exacerbated the toll of Covid-19 on people of color, POLITICO’s Ben Leonard reports. The devices, typically placed on a patient’s fingertip, use light beams to estimate oxygen saturation levels. Researchers identified problems with pulse oximeters years ago, with small studies pointing to misreadings in people of color in 1990, 2005 and 2007. Current FDA guidance recommends manufacturers’ studies include a minimum of 10 people and “at least 2 darkly pigmented subjects” or 15 percent of the overall group, but some experts argue the FDA needs to increase that pool. “It’s really shocking that it was only until 2021 for the FDA to actually issue an alert,” said Uché Blackstock, an emergency medicine physician and CEO of Advancing Health Equity. “And even in that alert last year, they didn’t even mention racial bias or race or racism in it.”
| | | WHO COVID PROGRAM SET TO WIND DOWN THIS FALL — The WHO’s program to ensure equitable distribution of Covid-19 vaccines, drugs and tests is likely to end in its current form this fall, POLITICO’s Erin Banco and Ashleigh Furlong report. The program, dubbed the Access to Covid-19 Tools (ACT) Accelerator, has struggled to secure funding from wealthy nations, and its end raises questions about how low-income countries will be able to fight future Covid surges that are all but guaranteed. Questions about the consortium’s fate come as funding for the global Covid effort has largely wound down, with governments turning their attention to other needs. Still, some countries have already pledged money to ACT-A for later this year, though it’s unclear what would happen to that money if the program were to fold or transition into a new entity.
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USAID's Atul Gawande (pictured here in an undated photo) talked with POLITICO about his plans to help low-income countries fight the current pandemic and prepare for the next one. | Bridget Mulcahy/POLITICO | USAID LOOKS TO HELP AMID MULTIPLE HEALTH CRISES — The head of the U.S. Agency for International Development’s global health office faces no small feat — helping low-income countries fight the current pandemic and prepare for the next one, all while managing simultaneous public health crises, Erin writes. Her profile of Atul Gawande focuses on how his office plans to carry out its work when it’s unclear whether Congress will appropriate the funding to do so. Gawande said his office will prioritize recruiting and retraining the health care workforce globally, helping to bolster health care systems in hopes they’ll withstand another infectious disease outbreak. “Public health lives in a boom-bust cycle where when the disease is at its worst is when people are willing to make an investment,” Gawande warned. “And then when the tide has gone out, people … decide, ‘Now I don’t have to worry about it.’ But the tide is coming back.” CUREVAC SUING BIONTECH FOR IP INFRINGEMENT — Biopharma CureVac said Tuesday it filed a lawsuit in a German regional court against BioNTech and two of its subsidiaries, which CureVac argues improperly used intellectual property to make and sell Covid-19 vaccine Comirnaty. “BioNTech's work is original, and we will vigorously defend it against all allegations of patent infringement,” BioNTech said in a statement.
| | | | INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY. | | | | | | | | SOUTH DAKOTA BANS TELEHEALTH ABORTIONS — South Dakota’s telehealth abortion ban became law on Friday, adding to the list of states with trigger laws going into effect after the Supreme Court’s Dobbs decision. All abortions in South Dakota are now illegal unless performed to save the mother’s life, but the telehealth prohibition specifically targets health care providers’ ability to virtually prescribe abortion pills, which are FDA-approved for use up to 10 weeks of pregnancy.
| | | ASTRAZENECA TO ACQUIRE BLOOD CANCER DRUG MAKER — AstraZeneca announced plans Tuesday to acquire TeneoTwo and its blood cancer drug that’s in early-stage testing. The transaction, expected to close in the third-quarter, will see AstraZeneca acquire TeneoTwo’s outstanding equity for $100 million at closing.
| | | NIH STUDY: COVID IMMUNE RESPONSE MAY DAMAGE BRAIN — A small NIH study examined a Covid-induced immune response that damages blood vessels in the brain, potentially providing early clues about how the disease can lead to persistent neurological issues. Researchers believe that if the study subjects had survived Covid, they would have gone on to develop long Covid.
| | | Kaiser Health News’ Arthur Allen explores Pfizer’s outsized role during the Covid-19 pandemic.
| | | The FDA is asking for nominations for nonvoting industry representatives for several medical device advisory committee panels. The FDA issued two draft guidances Tuesday pertaining to a 2013 law concerning drug supply-chain security. One would identify standards for secure electronic data exchange within the pharmaceutical distribution supply chain, while the other would help industry and state and local governments identify trading partners subject to the law. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
