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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 David Lim and Lauren Gardner | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | With Katherine Ellen Foley
| | | — Biden is set to touch on drug pricing, but don’t expect it to be a focus during his State of the Union address. — FDA will review supplemental data to Pfizer’s application for a biosimilar to compete with Humira. — FDA officials held virtual meetings with PhRMA, Quest Diagnostics and Apple earlier this month. It’s Tuesday. Welcome back to Prescription Pulse. Your authors are excited to learn when they can expect to see peak cherry blossom bloom in the District today. 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. | | | | | | BIDEN’S SOTU APPEARS LIGHT ON DRUG PRICING — President Joe Biden is set to address the nation tonight. Don’t expect new drug pricing remarks to be front and center. A preview released by the White House indicates a proposal to address prescription drug costs will be sandwiched between an array of remarks about the broader economy. “He will lay out specific, practical measures that would reduce costs for families right now, including prescription drug costs and health care premiums, child care and pre-k costs, and energy costs,” the White House preview states. PhRMA is already circulating talking points. The lobby for brand drug manufacturers on Monday proactively tried to counter what will likely be a familiar call by Biden for Congress to allow Medicare to negotiate the price of expensive drugs. The trade group, which spent $29 million on lobbying last year, argued that prescription drugs “are not fueling inflation.” PhRMA director of public affairs Sarah Sutton pointed to data from the Bureau of Labor Statistics showing the index for prescription drugs rose 1.3 percent over the past year. HOUSE CLEARS BILL WITH NEW REAGAN-UDALL FUNDING — The House on Monday passed by voice vote a Senate version of a bill that increases funding for the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration. The legislation, which passed the Senate in June, heads to the president’s desk.
| | | FDA TO REVIEW MORE DATA ON HUMIRA BIOSIMILAR — FDA accepted for review Pfizer’s prior approval supplement to its biologics license application for a biosimilar that could be used interchangeably with AbbVie’s Humira, the company said Friday. The supplement includes data that shows Abrilada was equivalent to Humira when rheumatoid arthritis patients switched between the two treatments multiple times. Approval of Pfizer’s biosimilar could lower drug costs for those patients once more options are allowed on the market. FDA LEADERS MEET WITH PhRMA, APPLE, QUEST — CDER Director Patrizia Cavazzoni and other FDA staffers met virtually with representatives from PhRMA on Feb. 7, according to a public calendar published by FDA. CDRH Director Jeff Shuren, CDRH Digital Health Director Bakul Patel and other high-level FDA staffers met with Apple executives, including its director of health Divya Nag, on Feb. 9 to discuss “general medical device updates.” FDA Diagnostics Director Timothy Stenzel and Shuren met virtually with Quest Diagnostics executives on Feb. 14 to discuss Covid-19 serology, or antibody, testing. HHS’ Meg Sullivan, White House senior advisor for Covid response Tom Inglesby and NIH’s Bruce Tromberg also attended.
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | CDC: MASKS CAN COME OFF IN PARTS OF THE U.S. — CDC on Friday said data shows most of the country can stop wearing masks indoors in public settings, as the agency shifts its pandemic management metrics to focus on hospitalizations as opposed to Covid-19 case counts. CDC guidance now divides the country into three levels, POLITICO’s Erin Banco and Sarah Owermohle report: “low,” or regions where severe disease is scarce and has limited effect on hospital capacity; “medium;” and “high,” or areas where severe illness is prevalent and Covid could significantly affect the health care system. The shift’s timing coincides, of course, with Biden’s State of the Union address tonight at the Capitol, where masks are now optional, POLITICO’s Katherine Tully-McManus writes. We’ll be interested to see how masked up the chamber is — or isn’t — during the speech. COVID VAX EXEMPTIONS EASY TO COME BY — Anecdotal evidence suggests religious exemptions for health care workers subject to the Covid vaccination mandate are widespread. Several hospital officials told POLITICO’s Rachael Levy and Megan Messerly they believe they have to approve the requests. The federal government doesn’t track the number of religious exemptions, but several executives said they’ve helped avoid laying off dozens of employees. Federal officials require that a worker’s religious beliefs be “sincerely held,” making hospitals reluctant to question their assertions unless their requests include overtly political language. But attorneys say it’s clear some people are lying about their beliefs and using the exemption as a compliance loophole, with workers submitting requests copied and pasted from websites.
| | | FDA: REGULARLY MONITOR ENDOVASCULAR AORTIC REPAIR PATIENTS — FDA on Monday endorsed recommendations made by its Circulatory System Devices Panel of the Medical Devices Advisory Committee that patients who have had endovascular aortic repair to treat an abdominal aortic aneurysm should be monitored for adverse events for the rest of their lives. People should get imaging within a month of surgery — and then annually — to help proactively identify and mitigate threats like “endoleaks, device migration, loss of patency, and failure of aneurysm sac regression” before a life-threatening event occurs.
| | | TOP FTC ECONOMIST RESIGNS AMID DISAGREEMENTS OVER PBM STUDY — Marta Wosinska, the FTC’s Bureau of Economics director, resigned on Feb. 16, a day before the FTC was set to vote on a study into pharmacy benefit managers, POLITICO’s Leah Nylen reports. The resignation came amid fierce internal debate about the agency’s plans to study the PBM industry, a frequent target for lawmakers, patient groups and independent pharmacies who blame the industry for contributing to high drug prices. But three people speaking anonymously to discuss internal agency deliberations didn’t know Wosinska’s specific objections to the proposed study. She didn’t respond to emails and calls for comment. The FTC did not comment.
| | | MODIFIED-RISK CIGARETTES TO HIT CHICAGO MARKET THIS MONTH — 22nd Century Group, a New York-based biotech company, will begin its pilot launch of VLN King and VLN Menthol King cigarettes in Chicago, the company said ahead of its earnings call later today. FDA classified those cigarettes as being “modified risk” late last year and authorized 22nd Century Group to advertise them as having “95 percent less nicotine” than traditional cigarettes, helping users reduce their nicotine intake. Nicotine is the addictive substance in cigarettes, though most health risks come from burning tobacco. Those two cigarettes are the only products 22nd Century Group has brought to market; yesterday, it said its international product launch would be in South Korea. They’re also the third group of products FDA has ever classified as “modified-risk” tobacco products. In 2019, the agency gave the designation to a smokeless tobacco pouch from Swedish Match USA. In 2020, FDA gave it to the IQOS cigarette, a heated tobacco product from Philip Morris International. However, a patent dispute with British American Tobacco resulted in the products being pulled from U.S. markets in 2021. FDA DELAYS GRAPHIC WARNING REQUIREMENT ON CIGARETTES — Tobacco companies won’t have to include graphic warning labels on cigarette packaging and advertisements until April 9, 2023, according to an FDA-finalized rule. FDA published the final rule in March 2020. Originally, companies had to begin to include the labels by June 18, 2021, but lawsuits against FDA have pushed the deadline back several times.
| | | Emeka Egwim will be the Health Resources and Services Administration’s director of the Office of Special Health Initiatives’ Office of Pharmacy Affairs. The Alliance for Health Policy has added Alston & Bird attorney Michael Park and Healthfirst CEO Pat Wang to its board of directors. Graeme Crews is now press secretary for the House coronavirus crisis select subcommittee. He previously was a senior media strategist for the Southern Poverty Law Center.
| | | ABORTION PILL DEMAND SOARS IN TEXAS AMID BAN — Texans are placing a record number of online orders for abortion pills after the state banned abortion after six weeks of pregnancy, POLITICO’s Alice Miranda Ollstein writes. Orders for the drug from international nonprofit Aid Access spiked 1,180 percent in the first week after the law took effect in September. While orders dropped over the next few months, a study found they remained 175 percent higher than before the state law kicked in.
| | | WTO DIRECTOR-GENERAL CALLS FOR MORE 'POLITICAL WILL' ON COVID — In an interview with POLITICO’s Erin Banco , Ngozi Okonjo-Iweala said that World Trade Organization member states are still in “difficult” conversations about a potential agreement on an intellectual property waiver that would allow countries to more easily manufacture the Covid-19 vaccine. She added that while talks continue, the world needs to find ways to bolster vaccine tech transfer so countries are prepared to manufacture the vaccines should an agreement be reached.
| | | New data from New York state shows the Pfizer-BioNTech Covid vaccine is far less effective at preventing infection among 5- to 11-year-olds than among older children, The New York Times reports. Amazon is launching a program that will allow Echo device users to ask to speak to a telehealth doctor for non-emergencies, Tom Murphy and Anne D’Innocenzio write for The Associated Press.
| | | FDA issued final guidance outlining recommendations on how to research what is most important to patients to inform drug development.
| | 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 | | | | |  |
