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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 Lauren Gardner and David Lim | Presented by SimpliSafe | With Katherine Ellen Foley, Alice Miranda Ollstein and Emily Martin | | | — Pfizer and BioNTech will ask the FDA next month to approve a third dose of its Covid-19 vaccine for emergency use. — Meanwhile, pressure is growing for FDA to formally approve the Pfizer and Moderna vaccines. Pfizer says its application is complete. — Regulators have revised the label for a controversial Alzheimer’s drug to indicate it’s intended for patients in the early stages of the disease. It’s FRIDAY, welcome back to Prescription Pulse. What happened to the slow news week? 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. | | | | | | PFIZER, BIONTECH TO SEEK FDA OK FOR THIRD SHOT AS BOOSTER — The companies announced Thursday that early data shows a third dose bolsters antibodies against the original coronavirus strain and the Beta variant, Lauren reports. They thus expect a booster to provoke a similar response to the Delta variant that’s become the dominant strain circulating in the U.S. More data and the formal petition to FDA are expected in August. But CDC and FDA on Thursday night said fully vaccinated Americans don't need booster shots. "We are prepared for booster doses if and when the science demonstrates that they are needed," the agencies said in a joint statement. IMPATIENCE GROWS WITH FDA OVER FULL APPROVAL FOR COVID SHOTS — Some medical experts have taken to social media in recent days to sound off on what they say is a slow, opaque process at FDA for approving Covid vaccines, arguing that full approval now — or at least more information from the agency about its timeline and approach — would help persuade unvaccinated Americans to get their shots. “I don’t think there’s anything that can move the needle more in the U.S.,” said Eric Topol, director of the Scripps Research Translational Institute. Status update: FDA wouldn’t give Lauren a timeline for its decision, which is standard practice in the license application process. The agency “is working as quickly as possible to review applications for full approval,” spokesperson Abby Capobianco said. Pfizer said that it’s submitted its application “in full,” whereas Moderna is still working through the rolling submission process whereby it files portions of the document as they’re completed. What will it take? Full approval is expected to lead to more businesses and schools requiring the vaccines to some degree, which could help encourage vaccination. But it’s unclear the extent to which a formal seal of approval on its own will convince the unvaccinated to roll up their sleeves. BECERRA WALKS BACK VACCINATION REMARKS — HHS Secretary Xavier Becerra took to Twitter on Thursday to walk back his argument in a CNN interview that “it is absolutely the government’s business” to know which Americans have been vaccinated against the coronavirus, claiming his words were “taken wildy out of context.” “To be clear: government has no database tracking who is vaccinated,” he tweeted. “We’re encouraging people to step up to protect themselves, others by getting vaccinated. It’s the best way to save lives and end this pandemic.” DELTA MORE WIDESPREAD THAN CDC’s LATEST ESTIMATE — The more-transmissible Delta coronavirus variant is believed to be significantly more widespread than the current federal projections, according to two senior Biden administration health officials with knowledge of the situation. CDC data released late Tuesday shows the Delta strain accounted for more than 51 percent of new Covid-19 cases from June 20 to July 3. But the reality on the ground is likely much higher because states and private labs are taking weeks to report testing results to the CDC, the officials said. “It is everywhere now,” one of the officials said, adding that recent data shows the Pfizer Covid vaccine works well against the Delta variant. “The risk really is in the unvaccinated community. We’re starting to see more and more people get sick and need medical attention.” ASPR PLANS COVID-19 TESTING INDUSTRY DAY — HHS’ Office of the Assistant Secretary for Preparedness and Response is convening Covid-19 test makers and labs on July 22 for an industry day that aims to prepare for the next phase of the pandemic and discuss potential strategies to maintain preparedness efforts — like “warm base manufacturing, flexible contracting, stockpiling and industry base expansion” — for the future. RSVPs are due by July 15. “ASPR is beginning to synthesize lessons learned from the COVID-19 pandemic to prepare for the remainder of this pandemic and inform longer-term planning,” HHS Testing & Diagnostic Working Group lead industry officer Steven Santos wrote in an email obtained by POLITICO. | | | FDA REVISES LABEL ON CONTROVERSIAL ALZHEIMER’S DRUG — The FDA added additional guidance on the label for Aduhelm, the Alzheimer’s therapy from Biogen and Eisai, that received accelerated approval last month. The new label, which Biogen announced on Thursday, indicates that the drug is intended for “mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.” But analysts at SVB Leerink predicted Thursday in a research note the narrower label will not “impact peak sales for this product." Initially, the drug had been cleared for all individuals with Alzheimer’s disease — a move that raised eyebrows of health experts, who pointed out that other populations with the progressive neurodegeneration had not been studied in clinical trials. “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” Alfred Sandrock, Biogen’s head of research and development, said in a statement. Surprising language: Even top senior officials at the agency were shocked by the broad language used in Aduhelm’s initial label, and likely wouldn’t have endorsed its accelerated approval if they had known it could potentially reach such a large population, STAT reports. In a statement to POLITICO, a spokesperson for the agency indicated that the decision for the updated label came from prescriber and other stakeholders. “Hearing these concerns, FDA determined that clarifications could be made to the prescribing information to address this confusion,” the spokesperson said. The Alzheimer’s Association was one of the groups that had advocated narrowing Aduhelm’s prescribing labeling when the drug was initially approved. A spokesperson from the association said that it had no direct contact with the FDA to advise it on this matter, though it did host a public meeting discussing the label for which officials from HHS, FDA and CMS had registered to attend. Wiggle room: The new label does not limit the duration for which a person could use Aduhelm as treatment. It states the drug’s primary indication is for “treatment of Alzheimer’s disease,” which could keep individuals on the therapy for longer as the dementia progresses. MAJOR INSURER LOBBY ASKS CMS TO WEIGH IN ON ADUHELM — AHIP is urging the Medicare agency to create a national standard for how the drug is covered, citing the therapy’s “extraordinary clinical uncertainties.” Such a decision could have huge repercussions on the Medicare program, which is projected to spend heavily on the costly drug. In a June 30 letter, the trade group formally requested that CMS issue a National Coverage Determination to clarify whether and when Medicare will cover Aduhelm, as experts question the drug’s effectiveness. The insurer lobby is also asking for clarification on key questions, such as whether the agency will decide to cover imaging tests used to help detect Alzheimer’s disease. The formal request was made before the FDA’s decision to narrow the label. While AHIP praised that decision, the group still wants guidance from CMS on how Medicare will cover the drug. CMS hasn’t yet indicated how the agency will handle the decision. The agency is “reviewing the FDA's decision regarding aducanumab and will have more information soon,” a spokesperson said. | | | | 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. | | | | | | | | HOUSE DEMS DETAIL PHARMA SPENDING TO GIN UP SUPPORT FOR HR 3 — House Speaker Nancy Pelosi and Oversight Chair Carolyn Maloney released a new report Thursday that pushes back on the pharmaceutical industry’s arguments against a sweeping drug price negotiation bill Democrats are hoping to roll into their infrastructure package this fall. The report highlights drug company spending on executive compensation, share buybacks and dividends compared to R&D. The Democratic leaders are trying to shore up support for the effort amid dissent from within their party, POLITICO’s Alice Miranda Ollstein reports. But PhRMA’s Brian Newell dismissed the report as a “partisan exercise is clearly designed to garner support for an extreme bill that will erode Medicare protections and access to treatments for seniors.” The drug industry is lobbying against the effort to include the bill in the infrastructure package. HHS RESCINDS TRUMP-ERA CALL FOR IMPORTATION, INSULIN PROPOSALS — The Biden administration announced Thursday it’s withdrawing a request for proposals on how individuals could purchase prescription drugs from other countries and how companies could reimport insulin, all in the name of lower prices. Regulators said they were unaware of any submissions and will now “consider alternatives,” Lauren reports. Meanwhile, the administration has moved to throw out a lawsuit challenging the Trump HHS rule permitting drug imports from Canada, though it has yet to say how it might implement that program. MOST FAVORED NATIONS REDUX? — The Biden administration’s regulatory office received on Wednesday an economically significant proposed rule named the “Most Favored Nation (MFN) Model,” raising the possibility of a new public comment period and eventually potential finalization of a Trump-era proposal aiming to reign in drug costs. But the process could take months to complete. “We therefore suspect that this posting is intended more to serve as a potential regulatory vehicle for unilateral action if Congress fails to act, while also addressing court rulings that the previous administration exceeded its authority in finalizing the MFN without a proper notice and comment period,” Washington Analysis’ John Leppard wrote in a research note. OMB is also reviewing a final rule detailing the FDA’s medical device De Novo classification process that it received on June 28. | | | |   | | | | | | 15 MORE STATES SIGN ON TO MAJOR OPIOID SETTLEMENT — A bankruptcy court filing revealed that 15 states support a proposed settlement with OxyContin maker Purdue Pharma over its alleged role in the opioid crisis. The filing, which the U.S. Bankruptcy Court in White Plains, N.Y., made public Wednesday evening, includes support from the attorneys general for New York and Massachusetts, who had been among those calling for additional transparency and accountability measures in the settlement. Critics of the deal have argued that the Sackler family, which own the company but have not accepted any blame, don’t deserve legal protections. In a joint statement, House Oversight Chair Carolyn Maloney (D-N.Y.) and Rep. Mark DeSaulnier (D-Calif.) argued that “allowing the Sacklers to obtain legal immunity through Purdue’s bankruptcy would be a tragic miscarriage of justice.” Nine states and the District of Columbia have not signed on to the settlement. GRASSLEY URGES MORE OPIOID CONTROLS IN NATIONAL DRUG STRATEGY — Sen. Chuck Grassley (R-Iowa) urged the Biden administration Thursday to include more actions to deter fentanyl and synthetic opioid use in its forthcoming National Drug Control Strategy. He called for the document to outline how the Office of National Drug Control Policy would move to permanently schedule fentanyl substances and to address polysubstance abuse, which is growing common among opioid users. | | | FDA POSTS NEW MDUFA NEGOTIATIONS MEETING MINUTES — The FDA on Wednesday posted minutes from two MDUFA V reauthorization meetings held on April 7 and April 28. FDA presented its proposal for a total product life cycle advisory program at the first meeting, an idea it argues would “help nurture” the U.S. medical device ecosystem. “The TAP proposal builds on lessons learned from the COVID-19 pandemic response, including how early, frequent, and strategic communications between FDA and sponsors could yield more rapid patient access to safe, effective, and innovative medical devices,” the April 7 meeting minutes state. But industry questioned the necessity of the proposal, instead arguing the next user fee deal should focus on “getting back to basics” by “maintaining the current goal structure” and “seeking targeted improvements to the premarket review process.” “Industry believes that some aspects of the TAP proposal, for instance related to convening stakeholders such as private payors, would extend beyond the scope of MDUFA and beyond FDA’s purview overall and would require statutory changes to implement,” the April 28 minutes state. “Moreover, Industry is concerned that it would drive up program costs and put the fundamentals of the device review program at risk.” | | | | 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. | | | | | | | | CITY LEADERS' SUPPORT BACKFIRES ON CA SAFE INJECTION SITES BILL — California city leaders who supported legislation to allow supervised drug injection sites may have unintentionally derailed the bill's progress, POLITICO’s Victoria Colliver reports. The state Assembly Health Committee chair pointed to an April letter that city leaders sent to Attorney General Merrick Garland as his reason for declining to hear the bill in committee, stopping the bill from reaching the governor’s desk this year. The letter urged the DOJ to clarify that the sites would not be targeted by federal drug enforcement operations. | | | AFRICA SETS OUT TO SAVE ITSELF ON VACCINE PROCUREMENT — The director of the Africa Centre for Disease Control and Prevention announced that Africa is expecting the first doses from a deal secured through the African Vaccine Acquisition Task Team to arrive in the next two to three weeks, amid a surge of Covid-19 cases and low vaccine availability, POLITICO EU’s Ashleigh Furlong reports. | | | | 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. | | | | | | Ogilvy Health on Thursday announced Kim Johnson has been appointed its global CEO. Thermo Fisher Scientific announced Wednesday Alan Sachs is now the company’s chief medical officer. Karen E. Nelson is joining as the company’s new chief scientific officer. | | | Canadian researchers say they have found amino acids in the blood of certain people who got AstraZeneca’s Covid-19 vaccine that could lead to insights about the cause of associated rare blood clots, The Wall Street Journal reports. | | | FDA told health providers in a Thursday letter there are “potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium.” Quidel initiated in April a recall of 18,385 kits of Covid-19 Lyra RT-PCR assays due to “a significant risk of false negative results,” FDA announced on Wednesday. The Justice Department announced a $38.75 million settlement with Alere and Alere San Diego over alleged knowledge of defective blood coagulation rapid point-of-care testing devices; and a $27 million settlement with St. Jude Medical over allegations that the company knowingly sold defective heart medical devices.
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