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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 David Lim and Lauren Gardner | Presented by SimpliSafe | With Katherine Ellen Foley, Emily Martin and Alice Miranda Ollstein. PROGRAMMING NOTE: Prescription Pulse will not publish on Tuesday, July 6. We'll instead be in your inbox on Wednesday, July 7. | | | — The Biden administration is already studying how to apply lessons learned from the Covid-19 pandemic to the next one when it comes to testing. — Johnson & Johnson says a small lab study shows its Covid-19 vaccine appears effective against the Delta variant. — The pandemic spurred more drug shortages in the U.S. in 2020, according to an FDA report. It’s FRIDAY, welcome back to Prescription Pulse. The FDA used its newest social media platform to declare that hot dogs are sandwiches. Regardless of where you stand on the issue (correct answer: they are not sandwiches), your authors hope you have a safe July Fourth. 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. | | | | | | WALENSKY: DELTA VARIANT A GROWING THREAT TO UNVAXED AMERICANS — CDC Director Rochelle Walensky warned that the Delta variant of SARS CoV-2 was behind a recent uptick in Covid-19 cases, POLITICO’s Erin Banco, Adam Cancryn and Dan Goldberg report . So far, it appears that those who have received a complete Covid-19 vaccination are protected against the Delta variant, although the CDC is still pulling together data. Unvaccinated people are at a greater risk of contracting Covid-19 from the Delta variant because it is highly contagious. Roughy 57 percent of the U.S. population is fully vaccinated — a number below Biden’s initial goal of 70 percent ahead of July Fourth, due to dwindling demand for vaccines. J&J VACCINE SHOWS PROMISE AGAINST DELTA VARIANT IN SMALL STUDY — Johnson & Johnson's coronavirus vaccine performed well against the highly contagious Delta variant in data from a small laboratory study, the company said in a press release late Thursday. The single dose vaccine generated strong levels of neutralizing antibodies in blood taken from eight people who had received the J&J shot in the company’s late-stage vaccine trial. The level of antibody activity against Delta, the variant first identified in India, was higher than that seen for the Beta variant, which emerged in South Africa. Why it matters: Previous studies have suggested that the mRNA vaccines from Pfizer and Moderna are effective against the Delta variant, but until now there has not been any indication of how much protection the Johnson & Johnson shot offers against the strain. Johnson & Johnson also said that a second study showed that immunity from its single shot vaccine lasts at least eight months. Neither study has been peer-reviewed. But both have been submitted to the bioRxiv, an online research repository. BIDEN ADMIN WORKING TO IMPROVE TESTING READINESS FOR NEXT PANDEMIC — Federal health officials, along with testing labs and test makers, are weighing how to implement the lessons they have learned from this pandemic to prepare for the next one. That includes what types of government incentives could help keep companies prepared to quickly develop tests in the face of a new emergency, and whether to stockpile key testing supplies. An HHS official told POLITICO the government is weighing how to ensure the U.S. diagnostics industry does begin a future pandemic “from a standing start.” “It does mean that we will need to have some things in stockpile to cover ramp up when a new pandemic arrives, or a new major epidemic arrives,” the official said. | | | FDA: PANDEMIC CONTRIBUTED TO MORE DRUG SHORTAGES — The Covid-19 pandemic exacerbated drug shortages in the U.S., according to a report the FDA released Wednesday . By the end of 2020, there were 83 ongoing shortages, 43 of which were new. Authors of the report cited these shortages as a result of higher demand for certain products and workforce disruptions in manufacturing plans. Bridging the gap: The agency says it was able to prevent nearly 200 more shortages, in part because of additional aid granted through the CARES Act passed in March 2020. That law required drug manufacturers to report more information about potential disruptions to supplies and develop plans to build backstops against equipment pitfalls, in addition to allowing the FDA to expedite the emergency use authorization of certain products to prevent future shortages. Increasing transparency: To avoid shortages, the agency states manufacturers need to be more transparent about potential supply chain hiccups, and to build more redundancy in the production process. It does not lay out a concrete path forward for manufacturers, however. NICE WORK IF YOU CAN GET IT — The FDA is one of the better government agencies to work for, according to a recent employment survey from the Partnership for Public Service. The average government-wide score was 69 out of 100, while the FDA scored 79.8. | | | | 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. | | | | | | | | FDA FUNDING BUMP SAILS THROUGH COMMITTEE — The House Appropriations Committee approved legislation Wednesday by voice vote that would set FDA spending for fiscal 2022 at nearly $3.5 billion, not counting the user fees that agency brings in. That would amount to a $257 million increase from current levels. Lawmakers signed off on the bill without debating the FDA funding title (bummer!), but your co-host found a few noteworthy items in the draft committee report: Foreign inspections: The committee included $5 million above fiscal 2021 spending for FDA to establish pilot programs in India and China to increase the number of unannounced and short-notice inspections it conducts of drug manufacturers. “While COVID–19 has understandably delayed many routine inspections abroad, the Committee is concerned that FDA may not prioritize physical inspections as highly as other regulatory review methods,” the panel said. Clinical trial diversity: The committee directs FDA to report to Congress on addressing barriers to more diversity among those enrolled in clinical trials, targeting marginalized communities, women and pregnant and lactating individuals. Tobacco and vaping: Committee members urged FDA “to use its full authority” to address youths’ e-cigarette use, including studying age verification technologies that can help prevent underage access to the products. PEW, OTHER GROUPS ASK CONGRESS TO CONSIDER VALID ACT — A group of 18 advocacy organizations including the Pew Charitable Trusts and Friends of Cancer Research on Wednesday sent letters to the leaders of the House Energy & Commerce and Senate HELP Committees requesting that they prioritize diagnostics reform this Congress. A new iteration of the VALID Act was introduced last week. | | | |   | | | | | | MODERATE DEMS HIT WITH DRUG PRICING ADS — Amid a battle over what health policy provisions will make it into a reconciliation package later this year, the health advocacy group Patients For Affordable Drugs is out with a new six-figure ad campaign to pressure moderate Democrats, as well as a few Republicans, who have not yet endorsed allowing Medicare to negotiate drug prices, POLITICO’s Alice Miranda Ollstein reports. The ads target Sens. Tom Carper (D-Del.), Bob Menendez (D-N.J.) and Bob Casey (D-Pa.), and Reps. David Valadao (R-Calif.), Scott Peters (D-Caifl.), Richard Hudson (R-N.C.) and Kurt Schrader (D-Ore.) — lawmakers who have long been friendly to the pharmaceutical industry and have expressed reservations about government negotiation of drug prices. Ads targeting Sen. Michael Bennet (D-Colo.), who is up for reelection next year, were halted after P4AD said they received "strong assurances" that he supports the effort. DRUGMAKERS STICK TO JULY PRICE HIKES — As of Thursday, manufacturers hiked prices on 32 brand name drugs, according to GoodRx, the first of what’s traditionally a month of cost increases to prescriptions. More hikes are expected throughout July. “Big Pharma is flaunting the industry’s disregard for the millions of Americans who cannot afford their medications with this third major round of pandemic price hikes,” Campaign for Sustainable Rx Pricing Executive Director Lauren Aronson said in a statement. | | | FDA: USE ONLY NIOSH-APPROVED MASKS — The FDA on Wednesday revoked emergency use authorizations for non-National Institute for Occupational Safety and Health approved disposable respirators due to increased availability of masks. The agency is holding a webinar on July 13 at noon EST to discuss the policy change. “FDA had warned hospitals a few weeks ago that this was coming, so we think most were prepared for it,” American Hospital Association spokesperson Colin Milligan told POLITICO. “At the moment, the supply for N95s seems sufficient to handle this shift, so we think we may be fine.” The International Safety Equipment Association — which had asked the FDA to take the step — praised the move. “American health care professionals deserve reliable, U.S government-approved protection,” said ISEA President Charles Johnson. FDA ALERTS ON ISSUES WITH SOME PHILIPS VENTILATORS, BiPAP, CPAP MACHINES — The FDA on Wednesday issued a safety communication warning users of certain Philips Respironics ventilators, BiPAP, and CPAP machines made between 2009 and 2021 that foam in the devices may break down and “potentially enter the device’s air pathway.” “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device,” the FDA notice — which lists the affected devices — states. | | | DEXCOM SUES ABBOTT OVER GLUCOSE MONITOR PATENTS — DexCom on Wednesday sued Abbott, alleging the medtech giant’s Libre product line infringes on patents covering its continuous glucose monitoring technology. A previous patent infringement fight between the two companies was settled in 2014, but the covenant not to sue expired in late March, according to a Thursday Securities and Exchange Commission disclosure. | | | | 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. | | | | | | | | FTC TARGETS HEALTH CARE ENTITIES FOR INVESTIGATIONS — The Federal Trade Commission voted Thursday to green-light investigations into several priority areas over the next decade, including Covid-related harms and health care businesses such as pharmaceutical companies, PBMs and hospitals. The resolutions allow agency staff to use “compulsory process,” such as subpoenas for documents or testimony, in its inquiries. | | | DRUG COMPANIES, DISTRIBUTORS HIT BACK AT NY STATE IN OPIOID TRIAL — Drug companies and distributors pushed back against allegations that they helped fuel the opioid epidemic in the first jury trial to target major corporations in the opioid supply chain, POLITICO’s Shannon Young reports. Defendants, including Teva Pharmaceuticals, Allergan, Endo Pharmaceuticals, McKesson Corp. and their affiliates, rejected plaintiffs’ claims that they “caused, created or contributed to a public nuisance in Nassau County, Suffolk County or the state of New York.” | | | CUREVAC FAILS TO PROVE VACCINE IS 50 PERCENT EFFECTIVE — CureVac's coronavirus vaccine is only 48 percent effective, according to a final analysis of clinical trials, POLITICO EU’s Jillian Deutsch reports. The German mRNA vaccine was considered a front-runner at the beginning of the coronavirus pandemic, but it fell behind with repeated delays and disappointing efficacy results. The EU has a deal to purchase up to 405 million doses of the shot. | | | | 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. | | | | | | FDA takes action on patent transparency — The FDA this week unveiled an important update to its “Purple Book” — a database of approved biological products — to include critical patent information for reference products. The update follows the passage of the fiscal 2021 government funding bill, which included a measure requiring FDA to publish a “searchable, electronic” list of biologics, including a list of applicable patents. The information was required to be published by June 25, 2021. FDA’s patent list so far covers just three products: AbbVie’s Humira (63 patents) and Genentech’s Avastin and Lucentis (20 and 9 patents, respectively). The list could help promote development of biosimilar competition to both products by identifying patent barriers. FDA’s top biologics regulator on gene therapy — Speaking this week at the Drug Information Association’s annual meeting, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, offered his assessment of how the pandemic affected companies developing gene therapies. Marks said his office received about the same number of applications to initiate gene therapy trials in 2020 despite the pandemic. CBER is working with companies to identify which clinical trials may have been affected by the pandemic, such as cases where the trial site may have temporarily closed due to a local lockdown, and how they can still make use of collected clinical data. Marks also said the FDA is working to develop a new approach that could accelerate the development of novel gene therapies for small populations by leveraging what is known as “originator” therapies for “offshoot” products. | | | The Biden administration released an interim final rule Thursday outlining its plan to protect patients from surprise medical bills, POLITICO's Rachel Roubein reports. | | | FDA announced an Aug. 3 virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to discuss the 510(k) application for the TriGUARD 3 Cerebral Embolic Protection Device. CMS on Thursday published a proposed rule describing potential updates to the End-Stage Renal Disease Prospective Payment System for calendar year 2022. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
