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Presented by Biogen: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | Presented by Biogen | With help from Katherine Ellen Foley | | | — CDC Director Rochelle Walensky strengthened the agency’s booster shot recommendation Monday in light of the Omicron variant. — An FDA advisory committee meets to discuss Merck’s Covid antiviral pill. — Tobacco regulation could be make-or-break public health issue for Biden’s pick to head FDA It’s Tuesday. Welcome back to Prescription Pulse. It’s finally time to bring out our favorite holiday playlist. 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 Biogen: Having lost several family members to Alzheimer’s disease—including both of his parents, a grandfather, and an uncle—Greg understands from firsthand experience what his own diagnosis meant for both him and his family. Though his own life has changed dramatically, Greg has hope for future generations and others who are living with Alzheimer’s. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s. | | | | | | OMICRON EMERGES, BOOSTER TALK SURGES — As scientists worldwide scramble to find out more about the new Omicron coronavirus variant, the Biden administration has doubled down on its Covid booster shot push. Walensky strengthened the CDC’s booster recommendation late Monday afternoon, saying all American adults “should” get additional doses, your Rx PULSE scribes report. Just 10 days ago, she signed off on guidelines that said healthy adults under 50 “may” opt for boosters. The quick pivot in the face of Omicron’s unknowns drew plaudits from many — including some Covid experts who were previously not sold on broadly boosting the population. Increasing booster uptake “will buy us some time and provide us some extra protection until we figure out if we need to develop second-generation vaccines,” said Céline Gounder, a former Covid adviser to the Biden transition and former broad-booster skeptic. Still, others questioned what data CDC is basing the move on. Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, gave a sarcastic Twitter nod to what some of social media’s science set has bemoaned in recent months — policy decisions being made without, in their view, a clear discussion of the science backing them up. Paul Offit, a Children’s Hospital of Philadelphia pediatrician and independent FDA vaccine adviser, published an op-ed Monday morning in The Washington Post urging a push to reach the unvaccinated domestically and abroad amid Omicron’s emergence instead of boosting ad hoc. He told Lauren last night he stands by his position “unless the CDC has data that we haven’t heard about yet.” His co-authors on the piece? Marion Gruber and Philip Krause. Related: Pfizer is expected to seek emergency use authorization for its Covid booster for 16- and 17-year-olds as soon as this week, The Washington Post reports. Pfizer spokesperson Sharon Castillo confirmed the report to Rx PULSE. BIDEN: DON’T HIT THE PANIC BUTTON — President Joe Biden sought to soothe an anxious public Monday, promising a detailed plan by Thursday to continue fighting the pandemic through the winter, POLITICO’s Claire Rafford writes. Measures like shutdowns and lockdowns aren’t options “for now,” Biden said, “because if people are vaccinated and wearing their masks, there's no need for lockdowns.” More than 30 percent of the country remains unvaccinated, and many places (ahem, Washington) have jettisoned indoor mask mandates. FDA ADVISERS TO MEET ON MERCK’S COVID ANTIVIRAL — FDA’s independent advisory group that focuses on antimicrobials meets today to discuss a novel antiviral treatment from Merck and its partner Ridgeback Biotherapeutics. Should the agency authorize the pill, called molnupiravir, it would be the first Covid-19 treatment individuals could take at home, as opposed to in a health care setting. It could also greatly reduce the burden of hospitals if it keeps patients from becoming severely ill. Scientists will likely have questions about the pill’s efficacy …: Merck presented FDA with data that showed it reduced the hospitalization risk among high-risk patients by 50 percent. More recent data suggests that figure is more like 30 percent. … and about the pill’s safety for pregnant or nursing individuals: Animal studies showed the pill may cause birth defects or miscarriages. Pregnant people, who are at high risk for developing severe Covid, were not included in clinical trials. The advisory committee will discuss if molnupiravir is appropriate for pregnant people at all or whether health care providers could prescribe it on a case-by-case basis when the benefits are believed to outweigh the risks. The discussion may touch on whether those considerations should matter for everyone who can become pregnant. FDA’s posture: FDA appears poised to green-light the pill for adults at high risk for hospitalization or death from Covid who test positive, according to an agency presentation posted online Monday. Patients would receive the treatment within five days of symptom onset as long as they weren’t already hospitalized. | | | | 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. | | | | | | | | TOBACCO REGULATION COULD MAKE OR BREAK BIDEN’S PICK FOR FDA CHIEF — The tobacco and vaping industries and public health advocates agree on at least one thing: FDA’s Center for Tobacco Products has an underwhelming track record since it was created in 2009, Katherine reports. Tobacco kills nearly half a million people annually, which means CTP has the potential to make a huge impact on public health. But so far, it has been inconsistent with its regulatory power and has failed to challenge the industries’ largest players. What CTP needs, experts on both sides claim, is someone to give it clear priorities from the top down. Robert Califf, Biden’s pick to run FDA, has an opportunity to finally give the center some direction should he be confirmed by the Senate. “What the CTP does or doesn’t do in the next 24 months will, for most people, define whether it has made the fundamental difference that was hoped when the Tobacco Control Act was passed,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. The court system will force Califf’s hand: Public health groups have taken legal action against the agency for failing to regulate menthol cigarettes or rule on some of the country’s top e-cigarette players. And some e-cigarette companies have appealed the agency’s rejection of their products, claiming CTP didn’t properly evaluate their applications. These cases will likely come to a head in the coming months, setting standards for CTP moving forward. But Califf also has a chance to pick up a past commissioner’s work: In 2017, then-FDA commissioner Scott Gottlieb outlined a plan to reduce tobacco-related deaths through a number of initiatives, including lowering the amount of nicotine allowed in cigarettes. But these plans never took off partly because politics surrounding tobacco stifled those efforts: Lawmakers from states with heavy industry presence have historically opposed regulation that would hurt sales. And the White House, under both Democrats and Republicans, hasn’t always been up for the fight — leaving FDA defenseless. U.S. TRADE REPRESENTATIVE SIDES WITH R.J. REYNOLDS IN PATENT DISPUTE — The federal trade authority affirmed Tuesday an International Trade Commission ruling that IQOS, a heated tobacco product manufactured by Philip Morris International, infringed on two patents owned by R.J. Reynolds. As a result, PMI and Altria can no longer import IQOS products for sale in the U.S. IQOS products are one of two products FDA designated as a “modified risk” tobacco product. | | | |   | | | | | | Q&A WITH DEPARTING ACLA HEAD JULIE KHANI — The U.S. government must put more funding toward public health efforts such as bolstered data reporting, according to Julie Khani, the departing head of the American Clinical Laboratory Association. Khani, who is headed to diagnostics company Hologic as its vice president of government affairs, sat down with POLITICO to discuss the Covid-19 pandemic’s impact on commercial laboratories and her tenure atop the trade association that represents players like LabCorp and Quest Diagnostics. Read the full Q&A here. “I hope that one of the lessons learned from this pandemic is that we will robustly support a comprehensive data reporting system and the ability of agencies to really look at and review all of this data, because there have been gaps, and that's hampered our ability to respond,” she said. | | | | 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. | | | | | | | | Jenelle Krishnamoorthy has been promoted to vice president for global public policy and international affairs at Merck. She most recently was the company’s associate vice president for global policy for communications and population health. | | | OMICRON RAISES CONCERNS ABOUT GLOBAL VACCINE EQUITY AND HESITANCY — Global health experts say the emergence of the Omicron variant in southern Africa is a byproduct of vaccine inequity that could ultimately prolong the Covid-19 pandemic, POLITICO’s Carmen Paun reports. African Union officials have complained about the lack of vaccines since the U.S., United Kingdom and European Union pre-purchased the bulk of available supplies at the end of 2020. COVAX, coordinated by the World Health Organization and Gavi, has been unable to make up for the shortfall and reach the most at-risk people in poor countries. | | | A federal judge in Missouri temporarily blocked the Biden administration’s plan Monday to require staff vaccinations at all federally funded health facilities in 10 red states. The Senate is unlikely to confirm Robert Califf to lead FDA until 2022 after the White House failed to submit necessary paperwork on time to Capitol Hill, POLITICO’s Adam Cancryn scooped before the holidays. | | | FDA on Monday issued draft guidance outlining whether registry data are fit for use in regulatory decisions for drug and biologic applications. | | A message from Biogen: When Greg received the devastating news that he had been diagnosed with Alzheimer’s, he thought about his family members whom he’d watched grapple with the disease. Stunned yet not surprised by the news, Greg’s first concern was his children. Like all of those living with Alzheimer’s or supporting someone with the disease, Greg’s life changed dramatically as a result of his diagnosis. Despite his own challenges, Greg says caregivers are “the real all stars.” As those who have been impacted by the disease know all too well, Alzheimer’s affects not only the patient, but often has implications for and takes a toll on loved ones. Biogen is learning from those who came before us and listening to patients and caregivers in order to pioneer new advances in neuroscience that bring hope to future generations. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
