|
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 Rachel Roubein. | | | — Those who received the J&J Covid shot may need boosters of an mRNA vaccine to ensure immunity against the Delta variant. — FDA statisticians were worried about inconsistencies in Biogen’s late-stage trials for newly approved drug Aduhelm, according to agency-released documents. — The DEA finalized a rule Monday easing restrictions on mobile methadone treatment vans. It’s TUESDAY, welcome back to Prescription Pulse. Your writers are taking a glass-half-full approach to this week by viewing this full-blown D.C. summer as a free outdoor sauna. Stay hydrated, friends. 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. | | | | | | THE LATEST ON VACCINE MIXOLOGY — Scientists continue to study whether and when Covid booster shots may be warranted. But some are already placing their bets on the need for an additional shot of an mRNA option like Pfizer’s for those who already received Johnson & Johnson’s single-dose jab as the more dangerous Delta variant continues its march across the U.S. Some infectious disease experts are already opting for that approach, Reuters reports, despite federal regulators not yet recommending such a regimen. To be clear, the FDA and CDC haven’t recommended this approach and don’t yet have enough information on it — the CDC’s vaccine advisory committee didn’t reach any conclusions last week on thresholds or formulations for boosters. Leana Wen, an emergency physician and public health professor at George Washington University, told Prescription Pulse she hopes a recommendation on mRNA boosters for J&J shot recipients comes soon. “Scientifically, it would make sense that getting a second dose of an mRNA vaccine could boost the immune response for those who got the one-dose J&J vaccine,” she said. Boosters and the hesitant: Much of the small percentage of Americans who got the J&J jab would line up for a second dose to boost immunity. But the general prospect of needing booster shots is a big reason why already vaccine-hesitant Republicans are holding off, said Wen, who said that reason was prominent among those who participated in GOP pollster Frank Luntz’s focus group. “For many hesitant individuals, the idea of getting a booster shot somehow implies that there’s no reason to get the shot in the first place,” she said. “We need to recognize that that mentality exists.” More on mix-and-match: Early results from a British study show that mixing doses of two different Covid shots produces an immune response akin to a regular, single-brand vaccine schedule, Carlo Martuscelli reports for POLITICO from Europe. If those results continue to bear out, they could help relieve pressure on governments if vaccine supplies from certain brands are interrupted. | | | MORE ADUHELM CONTROVERSY — Statisticians at the FDA were highly concerned with the “inconsistency” of Biogen’s Phase III clinical trials for its newly approved Alzheimer’s drug, according to documents released by the agency on Monday. This skepticism was reflected in a slew of correspondence the agency made public last week, adding to the disputed opinions around the drug. The House committees on Energy and Commerce and Oversight and Reform launched a joint investigation into the decisions behind the new Alzheimer’s drug’s approval and sticker price . In addition to the controversy around the drug's efficacy, it threatens to balloon health care costs with a price tag of $56,000 annually per person — not to mention costs of brain scans needed to identify suitable patients. Industry remains optimistic: Last week, the FDA granted breakthrough therapy statu s to a similar Alzheimer’s drug candidate from Eli Lilly. The drug company is currently in Phase III trials for its candidate and plans to file for approval with the agency later this year. | | | WATCHDOG RELEASES REPORT ON INDUSTRY INFLUENCE ON PATIENT GROUPS — Patients for Affordable Drugs, one of the progressive groups pushing for legislation that would empower Medicare to negotiate pharmaceutical prices, released a new report today documenting the industry’s financial ties and influence on patient advocacy groups and charitable groups like the American Cancer Society and the Patient Advocate Foundation. The report, shared first with POLITICO’s Alice Miranda Ollstein, digs into the tax filings, financial statements, annual reports and other records of more than a dozen prominent patient advocacy groups. It finds they rely on funding from the pharmaceutical industry, and that most have industry representatives on their board of directors. The bigger picture: The report comes as negotiations on drug pricing drag on in both the House and Senate, with no sign that progressives and leadership that support Medicare negotiations have overcome opposition from their more moderate members, which threatens to derail efforts to include reforms in a bigger infrastructure package. | | | |   | | | | | | TELEFLEX COMPLETES RESPIRATORY UNIT SALE — Teleflex announced Monday it finished the $286 million divestiture of a sizable portion of its respiratory device unit to Medline Industries. | | | BIDEN ADMINISTRATION EASES RESTRICTIONS ON MOBILE ADDICTION TREATMENT VANS — The Drug Enforcement Administration finalized a rule Monday to make it easier for mobile vans to deliver methadone, an opioid addiction treatment, POLITICO's Rachel Roubein reports. Now, all licensed narcotic treatment programs will be allowed to use mobile units. Previously, they had to register their mobile services separately, which served as a barrier to deploying mobile units for some practitioners. This comes as drug overdose deaths over the past year have climbed to record levels. The mobile units will also be able to perform services such as counseling and prescribe another addiction treatment drug if a certain doctor is on board, a senior policy adviser told reporters Monday. | | | | 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. | | | | | | | | JUUL TO PAY NORTH CAROLINA $40 MILLION IN E-CIG SETTLEMENT — In a settlement reached Monday, Juul agreed to pay North Carolina for damages and change their market practices, state attorney general Josh Stein announced Monday . North Carolina is the first of 13 states to reach a settlement with the e-cigarette company. Stein initially brought a lawsuit against Juul in 2019 for its advertising practices, which it claims enticed teens to begin smoking. Though Juul denies any wrongdoing in the settlement, it agreed to start selling its products behind counters at all stores in the state, employ more stringent age verification online, and use advertisements with models at least 35 years old. Juul also agreed not to sell any new pod flavors or nicotine levels without FDA clearance, though currently the FDA has banned the sale of all e-cigarette reusable cartridge flavors aside from menthol and mint. At a House Oversight Committee hearing last week, acting FDA commissioner Janet Woodcock remained mum on whether the regulatory agency would squash the sale of menthol e-cigarette cartridges. | | | J&J SETTLES NY OPIOID CASE — New York State Attorney General Letitia James announced a $230 million settlement Saturday with J&J over its role in fomenting the state’s opioid epidemic. The deal also precludes the company from making or selling opioids in New York, while acknowledging its national exit from the business. | | | CANADA PUNTS DRUG PRICING REFORMS TO 2022 — Canada’s health department is delaying the implementation date of drug patent regulations until Jan. 1, 2022, POLITICO’s Andy Blatchford reports. “In consideration of the impact of the third wave of the COVID-19 pandemic and the ongoing efforts related to the pandemic response, this delay will provide industry with additional time to adapt to the new reporting obligations,” Maryse Durette, a Health Canada spokesperson, wrote in an email. ASTRAZENECA BEGINS LATE-STAGE VARIANT VACCINE TRIAL — AstraZeneca announced Sunday it is enrolling 2,250 participants in the United Kingdom, South Africa, Brazil and Poland into a Phase II/III trial for a vaccine candidate designed to combat the Beta variant. | | | Kate Cronin joins Moderna as a chief brand officer, moving over from Ogilvy Health. Susan Galbraith will lead AstraZeneca’s oncology research and development, from initial discovery through late-stage development. | | | | 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. | | | | | | | | Generic drug submissions continue to decline in 2021 — The FDA continues to receive fewer and fewer applications for its approval of new generic drugs, according to a review by AgencyIQ . An average of 94 abbreviated new drug applications were submitted to the FDA each month in 2017. That number dropped to 87 in 2018, 78 in 2019 and 65 in 2020. So far in 2021, the agency is averaging just 64 submissions per month. The decline could make it more difficult for the generic drug sector to continue to act as a control on drug costs in the future. Revised diagnostics reform bill emerges — A new iteration of the Verifying Accurate Leading-edge IVCT Development (VALID) Act was reintroduced last week by a bipartisan, bicameral group of legislators. The bill proposes to re-classify all in vitro diagnostic tests (now regulated by the FDA) and laboratory-developed tests (primarily regulated by CMS) as a new product type known as in vitro clinical tests (IVCTs). The new approach would provide a comprehensive, risk-based approach to regulation. AgencyIQ has an extensive analysis of the VALID Act proposal, the changes it would make and how it would affect the current diagnostics and laboratory testing sectors. | | | The Atlantic’s Katherine Wu explores what researchers think about the future virulence and transmissibility of the coronavirus and its variants. STAT’s Damian Garde, Adam Feuerstein and Matthew Herper are out this morning with an investigation into Biogen’s early conversations with FDA regulator Billy Dunn about Aduhelm. | | | The FDA on Friday published draft guidance outlining recommendations for drugmakers on how to comply with safety reporting requirements for drugs being investigated under an investigational new drug application or as part of an exempt bioavailability or bioequivalence study. The FDA announced Monday it is holding a workshop on July 21 to discuss regulatory endpoints for eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis. | | | | 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. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
