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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 Katherine Ellen Foley | With Emily Martin | | | — Pfizer executives meet with Biden administration health officials to back up their plans to apply for emergency use authorization of a third Covid vaccine dose. — FDA adds a warning to the J&J Covid vaccine amid rare cases of Guillain-Barré syndrome post-vaccination. — CMS begins process to determine coverage for Aduhelm, Biogen’s new Alzheimer’s drug. It’s TUESDAY, welcome back to Prescription Pulse. Here’s former FDA commissioner Scott Gottlieb’s new puppy, just because. 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). | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | PFIZER TAKES 3RD SHOT ADVOCACY TO BIDEN ADMIN — Pfizer executives met Monday afternoon with the country’s top public health officials to go over early data on booster shots from its ongoing Covid vaccine trials, just days after announcing plans to petition the FDA to permit a third dose under its emergency authority. The company called the meeting “productive” and stressed that it agrees with the government that science will drive decisions on when and whether booster shots for Covid are necessary. An HHS spokesperson reiterated that fully vaccinated Americans don’t need boosters now, and the administration is ready to deploy those doses “if and when the science demonstrates that they are needed.” Expect the expected: Despite CDC and FDA’s testy response to Pfizer’s announcement last week, administration health officials believe vulnerable populations — namely, the elderly and the immunocompromised — will eventually need Covid booster shots, but it’s still a question of when, POLITICO’s Adam Cancryn, Sarah Owermohle and Erin Banco report. The issue has been the subject of internal debate and of discussions with vaccine manufacturers for months, they write, so Pfizer’s announcement took officials by surprise. Complicating factors: The science is still developing, and White House officials don’t want to get ahead of the data when there’s plenty of vaccine hesitancy. Second, other countries are going full steam ahead on booster programs, making the U.S. look like it’s lagging. And lastly, plenty of people worldwide don’t have the easy vaccine access most Americans enjoy, raising questions about equity if wealthy nations begin administering additional doses when many other countries are still scrambling for supply. J&J TAKES ANOTHER HIT AS FDA ADDS GUILLAIN-BARRE WARNING — News of another side-effect warning comes months after the shot’s rollout was paused over concerns about a rare blood-clotting condition. Preliminary cases identified in the vaccine side effect database run by the CDC and the FDA number about 100 among 12.8 million doses administered — an exceedingly small fraction that federal health officials say shows the benefits of immunization vastly outweigh the risks. J&J acknowledged in a statement that the reported case rate “exceeds the background rate by a small degree” while defending its product. “A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic,” the company said. Still, J&J has taken massive PR hits since its shot was approved in February, first with the blood-clotting cases and then when contractor Emergent spoiled millions of doses at its Baltimore facility. While the single-dose vaccine lags well behind Pfizer’s and Moderna’s two-dose regimens in terms of uptake, it had been expected to help the Biden administration close the vaccination gap among hard-to-reach populations. It’s unclear how the latest warning, which the CDC’s vaccine advisory group will probe publicly soon, will affect the shot’s administration. WHITE HOUSE HITS BACK AGAINST COVID VACCINE FEARMONGERS — Meanwhile, Biden administration officials are beginning to rebuke right-wing pundits and GOP lawmakers who spread vaccine misinformation after initially ignoring them to avoid calling attention to their arguments. The proliferation of inaccurate data on the vaccines “is literally killing people,” White House spokesperson Jen Psaki said. | | | FDA CHIEF CALLS FOR PROBE OF RELATIONSHIP BETWEEN AGENCY AND BIOGEN — The FDA’s acting commissioner called for an independent investigation of the regulatory agency and the drugmaker Biogen on Friday. The request comes as the controversy over Biogen’s new Alzheimer’s drug, Aduhelm, continues. Since the FDA granted Aduhelm accelerated approval in June, stakeholders have questioned whether the clinical data backing the drug actually merited its approval. Several external advisors to the FDA resigned over the decision, and just last week the agency updated the labeling requirements to reflect that only adults with early Alzheimer’s disease should begin treatment with it. The review by the Department of Health and Human Services inspector general will establish “whether any interactions that occurred between Biogen and FDA review staff are inconsistent with FDA policies and procedures,” Janet Woodcock wrote in a letter she tweeted Friday, promising full cooperation from the agency. Adding on to other investigations: The House committees on Oversight and Reform and Energy and Commerce formally requested extensive materials from Michel Vounatsos, the head of Biogen, as part of an investigation into Aduhelm’s approval launched earlier this month. On Monday, the heads of these two congressional committees requested all data on the drug’s safety and efficacy, correspondence with FDA officials on the regulatory process, meeting notes and marketing material Biogen planned to use. | | | SENATORS TO PROBE COMPETITION IN PHARMA MARKETS — The Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights holds a hearing today on how drug company practices — like “pay-for-delay” tactics to keep generics out of the market — have contributed to the rising costs of their products. Panel Chair Amy Klobuchar (D-Minn.) plans to focus on antitrust legislation for the pharmaceutical industry. Now that there’s a “light at the end of the tunnel” to the pandemic, she said, lawmakers have the bandwidth to address competition within the industry. “We have some opportunities coming up to finally do something about this instead of people just putting them in their political ads — on both sides, honestly,” Klobuchar told Rx Pulse Monday evening. | | | MEDICARE WILL REVIEW COVERAGE OF ALZHEIMER’S DRUG — CMS has initiated a potentially months-long review process to determine its coverage of Aduhelm, POLITICO’s Rachel Roubein reports. Biogen prices the drug at about $56,000 annually. CMS’ process, called a national coverage determination, could cap the amount the federal service reimburses for the drug, and could also set a national standard for coverage, rather than give discretion to local contractors. A 30-day public comment period begins today, and the agency will hold two public listening sessions this month. Medicare is expected to propose a coverage policy within six months, which will be open to a second 30-day public comment period. The decision will be made in nine months. Delayed accessibility: Despite receiving approval in June, access to Aduhelm has been slim outside of ongoing clinical trials. Multiple physicians told POLITICO that while some of their patients are interested in receiving the infusion, they haven’t prescribed it yet due to ongoing decisions about administration procedures and coverage. “Everyone's just waiting for this Medicare decision” as to how it would cover the drug, said R. Scott Turner, a neurologist at Georgetown University. Physicians also are concerned about whether CMS will cover the brain scans needed to detect whether a person has the telltale protein buildups of Alzheimer’s in their brains. These scans were used in Biogen’s clinical trials, but are not required for the drug. “If the drug is prescribed based solely on a clinical diagnosis without a biomarker (spinal fluid or PET), I would estimate that at least 30 percent of patients would not actually have the drug target (amyloid) in their brains,” Gil Rabinovici, a neurologist at UCSF, told POLITICO. BETH LYNK TO RUN CMS COMMS — The HHS official and Planned Parenthood alum is moving to CMS to direct the agency’s office of communications, our POLITICO Pulse colleagues scooped. She also will serve as a senior adviser for external affairs to Administrator Chiquita Brooks-LaSure. Lynk joined HHS earlier this year as deputy assistant secretary for public affairs. | | | CHINA’S VACCINE MAKERS INK DEAL WITH COVAX — Chinese drugmakers Sinovac and Sinopharm have reached a deal with vaccine alliance Gavi to produce up to 550 million doses for COVAX, POLITICO EU’s Ashleigh Furlong reports. The agreement also gives Gavi the option to purchase another 60 million doses of the Sinopharm vaccine in the fourth quarter of this year and 50 million in the first half of 2022. Under the Sinovac deal, Gavi could buy another 150 million doses in the fourth quarter and 180 million in the first half of next year. MACRON’S PLAN TO BEAT BACK VACCINE HESITANCY — France President Emmanuel Macron is expected to agree to make vaccines mandatory for health and home care workers and enforce more travel restrictions as a fourth wave of infections threatens the country, POLITICO EU’s Clea Caulcutt and Helen Collis report. In France, where vaccine skepticism is especially entrenched, doctors are warning that the slowing vaccination rates could threaten the goal of reaching herd immunity by fall. Half of the French population has received their first jab, and only a third have had both doses. | | | FDA on record pace for drug approvals: The FDA’s Center for Drug Evaluation and Research approved more novel drugs during the first half of 2021 than at any point in at least the last decade, a review by AgencyIQ has found . Between January and June of 2021, the FDA approved 27 molecular entities, more than the previous record (25 in 2020) and more than twice the number approved in 2019 (13). The 2021 numbers are far above the prior 10-year average (17.1 between 2011 and 2020). Of the center’s 27 approvals, 11 were products indicated to treat rare diseases. Ten were oncology products. In addition, 10, or 37 percent, were approved through the accelerated approval pathway, far more than in prior years. | | | | 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. | | | | | | | | The FDA’s approval of Aduhelm adds fuel to the fire of a heated debate in the Alzheimer’s research community, Laurie McGinley writes for The Washington Post. The drug clears amyloid protein buildup from the brain — which supports the idea that the clumps play a key role in the disease. But it’s still not clear whether they are the root cause. Two quarter-doses of an mRNA Covid-19 vaccine may trigger adequate protection from Covid-19 — suggesting a possible solution to vaccine shortages in certain parts of the globe, Elie Dolgin reports in Nature. | | | FDA is requesting public comment on the proposed collection of information on medical device labeling regulations. FDA has updated the language in the emergency use authorization issued to Johnson & Johnson’s Covid-19 vaccine to include warnings about Guillain-Barré syndrome as a possible rare side effect. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
