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Presented by the Coalition for Affordable Prescription Drugs (CAPD): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and David Lim | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | With Leah Nylen and Alice Miranda Ollstein
| | | — Moderna plans to ask FDA to authorize its Covid-19 vaccine for kids 6 months to 6 years old. — Democrats are pivoting to a legislative push to target the cost of insulin with their broader health agenda stalled. — FDA makes its first e-cigarette authorization of 2022, allowing more tobacco-flavored vapes on the market. It’s Friday. Welcome back to Prescription Pulse. How are your NCAA brackets holding up? 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 the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies’ claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs and shows that price trends in rebated and non-rebated drugs were comparable over the last four years. Don’t be fooled by Big Pharma: their prices are the problem. Learn more. | | | | | | MODERNA PLANS TO ASK FDA TO AUTHORIZE COVID-19 VACCINES FOR YOUNGEST KIDS — Moderna said Wednesday it would ask FDA to authorize its Covid-19 vaccine for children 6 months to 6 years old in the coming weeks, Katherine reports. Gimme the data: The company said the vaccine met its primary endpoint in late-stage clinical trials. In children, two doses of 25 micrograms of the mRNA vaccine generated an immune response comparable to young adults who received two 100 microgram doses of the vaccine. Most side effects were similar to the ones seen with adults, and no children developed inflammation of or around the heart — two of the most concerning side effects seen with the Moderna vaccine. Actual efficacy was lower. Kids 6 months to 2 years were 43.7 percent protected against symptomatic Covid, and kids 2 to 6 were 37.5 protected. No children developed severe disease. In a White House briefing Wednesday, Anthony Fauci, Biden’s chief medical adviser, said the vaccine’s efficacy data were par for the course of the Omicron wave, the dominant wave throughout the trial. “The data looks pretty good right now,” he said. “They are going to make those data available to the FDA … within a reasonable time period.” What about Pfizer-BioNTech? The pair currently manufacture the only vaccine authorized for children as young as 5. In December 2021, they said their vaccine produced an adequate immune response in children ages 6 months to 24 months but not in children between 2 and 5 years. The companies are currently studying three doses of their vaccine and plan to have data ready by April. The Biden administration is watching closely: In addition to looking at vaccines for kids, the Biden administration is eyeing additional vaccine booster doses for adults 65 and older, POLITICO’s Adam Cancryn and Erin Banco report . These shots, which could be authorized within weeks, would be an effort to better protect high-risk people and stave off a wave of hospitalizations should infections climb as a result of the spread of the Omicron subvariant, BA.2. Currently, second boosters are recommended only for those with compromised immune systems.
| | | | SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today. | | | | | | | | DEMS TURN TO INSULIN WITH BROADER HEALTH AGENDA STALLED — Sen. Chuck Schumer (D-N.Y.) announced a plan Tuesday to bring legislation to the floor just after Easter that would cap the out-of-pocket cost for insulin products at $35 a month and take other steps to extend relief to people with diabetes, Alice reports. The new push, which will combine legislation by Sen. Raphael Warnock (D-Ga.) with a bipartisan bill from Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine), is still being negotiated. It is expected to combine an out-of-pocket cap on the price of insulin for some patients with an effort to target pharmacy benefit managers and a yet-to-be-determined mechanism aimed at reducing the drug’s list price. On a call with advocates and reporters Thursday, Warnock also announced that he plans to introduce a bill setting an out-of-pocket cap for Medicare Part D “in just a few short weeks.” Warnock said the bill will be, along with his insulin effort, “part of a more comprehensive effort to lower health care costs in general.” But progressive and industry groups alike are critical of setting out-of-pocket caps, warning that they simply shift the cost of drugs instead of lowering them and could raise older adults’ premiums. HOUSE GOP QUESTIONS FTC’S ON GRAIL CHALLENGE — A week after House Democrats raised concerns to the White House about potential delays to wider availability of multi-cancer early detection tests, GOP members are also weighing in, Leah reports. In a letter to Federal Trade Commission Chair Lina Khan, nine Republicans questioned whether the agency’s block of Illumina’s acquisition of cancer-detection startup Grail would delay the availability of early-detection cancer screenings. The letter was led by Rep. Gus Bilirakis (R-Fla.), the top GOP member on the House Energy and Commerce Consumer Protection Subcommittee, which oversees the FTC.
| | | FDA CLEARS MORE E-CIGARETTES FOR MARKET — Several more tobacco-flavored e-cigarette products manufactured by the company Logic will be allowed to remain on the market, Katherine reports . FDA ruled that Logic Pro, Power and Vapeleaf e-cigarettes, as well as tobacco-flavored cartridges, were likely to benefit adult smokers without enticing youth or never-smokers. These are the first marketing orders the agency has granted in 2022. In addition to authorizing those products, the agency rejected Logic’s applications to sell flavored products. It continues to assess the company’s menthol cartridges applications, though it continues to sell them at FDA’s discretion. One of two vapes on the market: The only other e-cigarette product on the market is Vuse, manufactured by tobacco giant R.J. Reynolds, and its tobacco-flavored pods. Logic also has ties to the combustible cigarette industry and is owned by Japan Tobacco Inc. Past due: FDA’s deadline to make decisions on vape applications was in September 2021. The agency has thousands of e-cigarette applications still pending, including those from major companies like Juul and NJOY.
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | MDUFA WATCH — FDA on Tuesday published performance goals for its medical device user fee program for fiscal years 2023 through 2027. The proposed recommendations outline how up to $1.9 billion in MDUFA V funding would potentially be used if Congress reauthorizes the program. “MDUFA V represents a substantial investment in the future of the agency's medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development," Jeff Shuren, the director of the Center for Devices and Radiological Health, said in a statement. The agency is holding a public meeting April 19 to discuss the proposal. Once it considers the input, FDA plans to send final recommendations to Congress later in that month. FDA FOUND SANITATION PROBLEMS, INFECTIOUS BACTERIA IN ABBOTT FORMULA PLANT — FDA identified Cronobacter sakazakii — the bacteria tied to four hospitalizations and two infant deaths in recent months — in numerous places in an Abbott infant formula plant, POLITICO’s Helena Bottemiller Evich reports.
| | | | DON’T MISS POLITICO’S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE. | | | | | | | | CareFirst BlueCross BlueShield has named Djinge Lindsay as its new director of public health.
| | | Benjamin Mazer explores the limitations of at-home Covid-19 antigen tests in The Atlantic.
| | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA to study accelerated approval’s effect on advertising — The FDA’s Office of Prescription Drug Promotion said this week that it’s moving ahead with two planned studies on patient understanding of accelerated approval language used on drug company websites. Accelerated approval is a regulatory pathway through which the FDA may approve drugs for serious or life-threatening illnesses based on “surrogate” endpoints — ones that are reasonably likely to predict the clinical benefit of the drug for a specific group of patients. Because the data used to support approval are preliminary, companies that obtain accelerated approval for a product must then conduct confirmatory testing. The FDA’s apparent concern is that patients may not recognize that the drugs are approved based on preliminary evidence, thereby affecting their behavior. Its research design is meant to assess possible consumer-friendly disclosures for a fictitious cancer drug and determine if viewers comprehend the disclosures. FDA has previously tested consumer-friendly information on accelerated approval in drug labeling but has never formally proposed a change. FDA diagnostics leaders: Prepare for a transition away from EUAs — Leaders of the FDA’s Office of In Vitro Diagnostics (OIVD) this week told companies during a Town Hall meeting that they should begin to prepare for an eventual transition away from the use of the Emergency Use Authorization process. FDA’s authority to issue EUAs is granted under the current Public Health Emergency but is a separate declaration than the overall emergency. Crucially, that means that any EUAs granted by the FDA are not rescinded when the public health emergency is declared over. However, while FDA doesn’t “have any reason to believe right now that the Secretary’s declaration would be terminated any time soon,” explained OIVD’s associate director for regulatory programs Toby Lowe, the agency does want companies to start preparing to transition their products to fully approved or cleared diagnostics. Companies may wish to consider extending EUA-related studies to support full marketing authorization, Lowe explained. “There’s no time like the present to get that started,” said OIVD director Tim Stenzel. Companies should also expect FDA to continue to require companies to monitor the impact of new and emerging viral variants.
| | | FDA on Tuesday published guidance recognizing a December 2021 Circular that provides specific labeling instructions for blood and blood components intended for transfusion. The agency also published guidance on some ophthalmic products on Tuesday to adhere to the U.S. Court of Appeals for the District of Columbia Circuit’s Genus Medical Technologies LLC v. U.S. Food and Drug Administration decision. Eye cups, eye droppers and other ophthalmic dispensers will now be regulated as drug-led combination products. The Office of Management and Budget is reviewing a draft guidance it received earlier this week on cybersecurity in medical devices and what information should be included in a premarket submission.
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): A new report finds that rebates do not result in higher drug prices. This new data offers clear evidence refuting drug companies’ claims that the rebates PBMs negotiate are to blame for increasing list prices for brand drugs and shows that price trends in rebated and non-rebated drugs were comparable over the last four years. The report also highlights how rebates promote competition and lower insurance premiums. Don’t be fooled by Big Pharma: their prices are the problem. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
