Manchin floats drug pricing in new counteroffer

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.

Mar 04, 2022 View in browser   By Lauren Gardner, David Lim and Katherine Ellen Foley Presented by the Coalition for Affordable Prescription Drugs (CAPD) On Tap — The president's State of the Union address prompted a quick response from a key centrist Democrat who wants to pass legislation targeting high drug prices. — The Biden administration has requested more Covid-19 funding — but much less than it initially wanted. — The FTC faces a deadline to decide whether to review Pfizer's merger with Arena.  It's Friday. Welcome back to Prescription Pulse. We spy FDA Commissioner Robert Califf's tweet noting the Office of Management and Budget is reviewing the agency's proposed rules that are likely to ban menthol cigarettes and flavored cigars. 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.   In Congress SOTU RECAP: MORE HEALTH THAN WE THOUGHT — Your morning hosts owe readers a mea culpa because President Joe Biden's State of the Union address contained far more health care and pharma references than we were expecting. Drug pricing got a mention, even as the president steered clear of saying the name of his stagnant social spending measure. Manchin outlines his ask: Sen. Joe Manchin (D-W.Va.) wasted little time putting together a counteroffer to the priorities Biden mentioned in his speech, POLITICO's Burgess Everett and Nicholas Wu report, raising a glimmer of hope for Democrats eager to unite around a legislative priority ahead of the midterms.   The centrist Democrat said prescription drug prices and tax reform are the two areas the party should target to raise revenue if they're going to move a party-line bill through the reconciliation process. WHITE HOUSE SHRINKS COVID AID REQUEST — The Biden administration slashed its request for Covid-19 aid from Congress by almost half this week amid growing GOP opposition to writing another check for pandemic response, POLITICO's Alice Miranda Ollstein and Erin Banco write. The White House has asked for $18.25 billion to purchase tests, treatments and vaccines — down from the $30 billion HHS Secretary Xavier Becerra argued for a few weeks ago — and $4.25 billion for USAID and the State Department to target the virus overseas. HELP COMMITTEE TO MARK UP PANDEMIC PREP LEGISLATION — Senate HELP Committee Chair Patty Murray (D-Wash.) and ranking member Richard Burr(R-N.C.) announced Wednesday they will hold a markup on their pandemic preparedness legislation on March 15 . The markup date gives them a hard deadline to formally introduce the bill, which has existed in discussion draft form since late January. Burr has already signaled he wants to see the legislation, a legacy issue for the retiring Republican, passed after a bipartisan amendment process on the Senate floor. The bill could become a vehicle for establishing ARPA-H, a new health research agency that's a Biden priority. What to keep an eye on: "CDC reforms remain an essential part of the final bill, and getting those changes right is the most important thing we can do to improve our future pandemic response," a GOP HELP Committee aide told POLITICO. SENATE REBUKES BIDEN COVID POLICIES — The Senate voted this week to approve Republican-backed efforts to roll back the national emergency declaration for the pandemic and end the president's vaccine mandate for health care workers. The measures are largely symbolic, as House leadership and the White House oppose them, and passed due to several Democratic absences.   A message from the Coalition for Affordable Prescription Drugs (CAPD):   Around the Agencies FTC FACES TEST ON PFIZER-ARENA MERGER — The Federal Trade Commission must decide by Wednesday whether to pursue an in-depth review of Pfizer's $6.7 billion acquisition of Arena Pharmaceuticals — a chance for the agency to make good on plans to rethink how it approaches pharma deals, POLITICO's Leah Nylen and Katherine report. Pfizer manufactures Xeljanz, a major ulcerative colitis drug that treats the autoimmune condition by blocking the production of proteins that agitate the immune system. Arena has yet to bring a product to market but has an ulcerative colitis drug candidate in late-stage clinical trials that works by reducing the amount of white blood cells in inflamed areas. In the past, FTC prosecutors focused on whether pharma companies owned drugs used to treat the same disease — especially if they work similarly. In an investor call, a top Pfizer executive said the company doesn't expect antitrust difficulties with the deal partly because Arena's candidate targets a different part of the immune system than Pfizer's drug. But critics of the FTC's record on pharma have urged the agency to take a broader approach, looking beyond overlaps at how a merger affects innovation and a company's incentives to spend money on research and development. Several called out Pfizer for lowering its R&D spending after earlier mergers. Eye on FDA FDA: COMPANIES SHOULD  DISSEMINATE RECALL INFO QUICKLY — Companies should maintain distribution records and use electronic communication to communicate recall actions rapidly, says a new final guidance issued by FDA on Thursday. "It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain," FDA Associate Commissioner for Regulatory Affairs Judith McMeekin said. MAKE SURE YOUR RAPID TESTS ARE AUTHORIZED — FDA this week issued a trio of safety communications cautioning Americans not to use unauthorized versions of at-home Covid-19 tests. The agency is concerned certain versions of Celltrion's DiaTrust, SD Biosensor's STANDARD Q and ACON's Flowflex tests might yield false results. HHS DELAYS REGULATORY SUNSET RULE — HHS is delaying the implementation of a Trump-era rule that would require the agency to review thousands of regulations at least once every 10 years, POLITICO's Ben Leonard reports. Agencies within HHS, including FDA, are concerned the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would be too time consuming for federal employees, who would need to review decades-old rules. Public interest groups filed a lawsuit against the government with similar concerns last year. Drug Pricing CIVICA RX STAKES A CLAIM IN THE AFFORDABLE INSULIN ARENA— Generic drug manufacturer Civica Rx announced plans Thursday to make and distribute three versions of insulin at a significant discount compared with brand names. Civica, a nonprofit company, is working with several partners to bring insulin vials and boxes of pen cartridges to market for a suggested price of no more than $30 and $55, respectively, by 2024. Coronavirus PHARMACISTS EYE TWEAKS TO 'TEST TO TREAT' — The American Pharmacists Association issued a statement highlighting the same issue Lauren noted as the White House unveiled its "test to treat" strategy for Covid after the State of the Union address — it limits the number of pharmacies that can participate since it doesn't eliminate restrictions on pharmacists prescribing Covid antiviral pills. "APhA will continue to work with the federal government to reduce barriers that prevent pharmacists from prescribing and being appropriately reimbursed for these products as well as to unleash the power of our nation's pharmacists to provide this needed care, particularly in underserved communities," the group said Thursday. Pharma Moves Julie Gerberding will become CEO of the Foundation for the National Institutes of Health in May, retiring from Merck as chief patient officer and executive vice president for population health and sustainability. HeartFlow announced Tuesday John Farquhar as its new chief executive officer. The Alliance for a Stronger FDA added Center for Science in the Public Interest deputy director of regulatory affairs Sarah Sorscher and Manatt Health partner Rachel Sher to its board of directors. Pharma in the States DESANTIS WANTS FLORIDA DRUG-IMPORT PLAN GREENLIT — Florida Republican Gov. Ron DeSantis urged FDA to approve a state application to implement a prescription drug importation program from Canada for certain medications, POLITICO Florida's Arek Sarkissian reports. Pharma Worldwide U.S. TO LICENSE SOME COVID TECH TO OTHER NATIONS — U.S. officials announced Thursday they would license certain government-developed technologies to the World Health Organization but not coronavirus vaccines that many countries have long called for, POLITICO's Sarah Owermohle reports Quick Hits Biogen began its corporate restructuring Wednesday by laying off employees after a rocky launch of its beleaguered Alzheimer's disease drug Aduhelm, STAT's Adam Feuerstein and Damian Garde report. The Sackler family agreed to pay up to $6 billion to settle lawsuits over the opioid epidemic, up from a previous offer of $4.5 billion, The Wall Street Journal's Jonathan Randles reports. Inside AgencyIQ FDA report shows device division struggled to meet performance targets in 2021 — FDA struggled last year to hit its standards for performance required under the Medical Device User Fee Amendments, according to a new quarterly report released by the agency's Center for Devices and Radiological Health. The MDUFA program is used to fund a significant portion of the FDA's reviews of medical devices. In return for industry funding, the FDA commits to meeting certain timelines for the review of products (i.e., within a certain number of days). The report shows that the FDA missed its targets in several key areas, including only reviewing about 73 percent of Premarket Approval applications for devices within 180 days (versus 92 percent the year before) and 86 percent of premarket notification submissions within 90 days (versus 95 percent the year before). The decrease in performance is likely due to the pandemic, according to AgencyIQ's analysis of various factors. Document Drawer FDA released three final guidances Tuesday on cancer clinical trials to reflect Biden's goal of building on his cancer moonshot initiative. 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 David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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