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Presented by the Pharmaceutical Care Management Association: 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 Pharmaceutical Care Management Association | With Katherine Ellen Foley | | | — The Senate health panel voted Thursday to advance Robert Califf’s nomination to lead FDA to the full chamber. — The Biden administration signed contracts with three Covid test manufacturers as it ramps up plans to send a half-billion at-home kits to Americans. — HHS sent three user fee agreements to Congress this week, but MDUFA is not among them. It’s Friday. Welcome back to Prescription Pulse. Humans aren’t the only ones with a monoclonal antibody treatment anymore. 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 Pharmaceutical Care Management Association: With Congress poised to fully repeal the rebate rule and prevent significant increases in both Medicare beneficiary premiums and Medicare Part D program costs, pharmaceutical industry representatives are once again attempting to divert attention by suggesting so-called point of sale rebate policies that would undo this progress. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | | 
Robert Califf testifies during his nomination hearing before the Senate Health, Education, Labor and Pensions Committee in Washington, D.C. | Win McNamee/Getty Images | SENATE HELP ADVANCES FDA NOMINEE — The Senate HELP Committee voted 13-8 Thursday to send Califf’s nomination to be FDA commissioner to the floor, putting the Biden administration one step closer to installing a permanent leader atop the agency. Sens. Bernie Sanders (I-Vt.) and Maggie Hassan (D-N.H.) bucked leadership in voting against the nomination. Just four Republicans supported it. “Sen. Patty Murray is working to get Dr. Califf confirmed by the full Senate as quickly as possible,” a Democratic committee aide told POLITICO. Let the whip count begin: Sanders’ and Hassan’s opposition, along with that expressed by Sens. Joe Manchin (D-W.Va.), Richard Blumenthal (D-Conn.) and Ed Markey (D-Mass.), means Democratic leaders need at least five Republicans to vote for Califf’s nomination on the floor, which would allow Vice President Kamala Harris to cast the tiebreaker. Ranking Republican Richard Burr of North Carolina strongly backs Califf’s bid to lead FDA and will likely work his side of the aisle to ensure sufficient support. Still, this may be a close one. With FDA’s critical role in the coronavirus pandemic response, a failed vote likely would spell a new level of acrimony in Washington. DEMS PRESS FDA TO REASSESS BLOOD DONATION RESTRICTIONS — FDA should reassess its recommendation that men who have sex with men defer donating blood for three months, Reps. Carolyn Maloney (D-N.Y.), Jamie Raskin (D-Md.), Alexandria Ocasio-Cortez (D-N.Y.) and Katie Porter (D-Calif.) wrote in a Thursday letter to FDA Acting Commissioner Janet Woodcock. “With the addition of an individualized risk-based assessment, the deferral period for all donors in the United States — including MSM — could potentially be eliminated,” the lawmakers wrote. “In light of the urgent crisis facing America’s blood supply, we urge FDA to take immediate action to reassess the existing three-month blanket deferral period for gay and bisexual men so that every person who can safely donate blood in the United States has the opportunity to do so.” HHS SENDS USER FEE AGREEMENTS TO CONGRESS — HHS on Wednesday transmitted to Congress three user fee packages — negotiated agreements between FDA and industry — for the Prescription Drug User Fee Act VII, Generic Drug User Fee Amendments III and Biosimilar User Fee Amendments III, both a source familiar with the process and a congressional aide told POLITICO. The action represents the latest step toward a potential five-year reauthorization of the so-called must-pass legislation, which dictates programs where industry pays fees to FDA in exchange for commitments to conduct timely reviews of medical products. An FDA spokesperson said details about the fifth iteration of the Medical Device User Fee Amendments will be released when negotiations with the device industry are finalized. “In order to respect the negotiation process, we cannot comment on any specific details,” the spokesperson said. HOUSE COMMITTEES APPLAUDS CMS DRAFT COVERAGE DECISION ON ADUHELM — Two House committees applauded the Centers for Medicare and Medicaid Services for its decision to cover the controversial Alzheimer’s therapy only for patients enrolled in an agency-approved randomized controlled trial. “We applaud the agency for striking a balance between the need for Alzheimer’s patients to access treatment with the need to gather more evidence on the treatment’s safety and efficacy through clinical trials,” House Energy and Commerce Committee Chair Frank Pallone, Jr. (D-N.J.) and Maloney, the House Committee on Oversight and Reform chair, wrote in a letter to CMS Administrator Chiquita Brooks-LaSure on Thursday. | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | BIDEN ADMIN SIGNS CONTRACTS FOR 380M HOME TESTS — The federal government late Thursday signed contracts with Abbott Rapid Dx North America, iHealth Lab and Roche Diagnostics for 380 million over-the-counter Covid-19 test kits. The Department of Defense, which ran the contracting process, said the tests will support Biden’s plan to make 500 million at-home tests available to the public for free to combat the Omicron variant. BIDEN PLEDGES TO BUY 500M MORE HOME TESTS — President Joe Biden announced Thursday the federal government plans to buy another 500 million at-home Covid-19 tests, POLITICO’s Nick Niedzwiadek reports. A White House spokesperson said the timeline for the new effort is “post the first 500” million home tests. ANTIBODY MAKERS REQUEST EUA TWEAK FOR NEW ADMINISTRATION — GlaxoSmithKline and Vir Biotechnology, makers of the only monoclonal antibody believed to be effective against the Omicron variant, requested an amendment to their emergency use authorization from FDA Thursday to allow the product to be administered intramuscularly. The treatment is currently given intravenously to Covid patients thought to be at risk of developing severe disease. The companies earlier this week announced an agreement with the federal government to buy an additional 600,000 sotrovimab doses for delivery in the first quarter of 2022. The deal includes an option for the U.S. to purchase more treatments in the year’s second quarter.
| | | | A message from the Pharmaceutical Care Management Association:   | | | | | | SCOTUS BLOCKS VAX-OR-TEST MANDATE FOR LARGE EMPLOYERS — The Supreme Court on Thursday blocked enforcement of President Joe Biden’s requirement that workers at larger businesses get vaccinated against Covid-19 or submit to masking and weekly testing, a major blow to the administration’s strategy for fighting the coronavirus’ spread, POLITICO’s Eleanor Muller and Josh Gerstein report. But the high court allowed a separate rule to proceed, which requires many health care workers to be vaccinated. “CMS is already implementing its health care worker vaccination rule in 25 states and territories that were not covered by preliminary injunctions,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Today’s decision will enable us to fully implement this rule, and we look forward to working with health care providers and their workers to protect patients.” FLORIDA MAN BUNDLED COVID TESTS WITH UNNEEDED DIAGNOSTICS — The Department of Justice announced Thursday that Christopher Licata, the owner of Boca Toxicology, pleaded guilty in the Southern District of Florida to a $6.9 million conspiracy where he bribed patient brokers into guiding unneeded genetic testing alongside Covid-19 tests to his lab. | | | HHS Secretary Xavier Becerra has appointed Angela Ramirez as his new deputy chief of staff. Ramirez joins the department from the White House, where she was a special assistant to the president and House legislative affairs liaison. She previously was chief of staff to then-Rep. Ben Ray Luján (D-N.M.). Chris Long will join the Better Medicare Alliance as vice president of government affairs. He served as co-founder and partner at Bluestone Strategies, a bipartisan government affairs firm. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | Biogen is eyeing potential acquisitions, STAT News’ Damian Garde and Adam Feuerstein report. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA seeks help on real-world data submissions — According to a new funding notice, the FDA is seeking research into how to map real-world data (RWD) standards into clinical research formats. The announcement, made in the form of a grant opportunity notice, comes after the FDA released guidance indicating it would look to advance process for drug submissions leveraging RWD. The basic problem is that the FDA has specific requirements for the submission of data to the agency by drug companies in support of new product applications (such as for new drugs and biologics). However, real-world data from electronic medical records or clinical registries are typically not structured in a way that allows them to be submitted to the FDA easily. The grant notice calls for a company to help the FDA to better understand, map and format real-world data to its submission standards, including the development of common denominators. FDA estimates of burden of supply chain requirement increase 2,700 percent — This week the FDA announced that it has revised estimates of the amount of time it will take companies involved in the shipment and transfer of drug products to comply with impending regulatory requirements under the Drug Quality and Security Act of 2013. The law was passed in an attempt to better secure the supply chain by requiring entities to “track and trace” drug products using unique serial numbers and strict reporting requirements. Those requirements apply to manufacturers, repackagers, wholesale distributors and dispensers like pharmacies. In September 2021, the FDA published a notice estimating the annual burden of reporting requirements related to submitting notifications of illegitimate products or products with a high risk of illegitimacy. At the time, the FDA said it expected the “annual disclosure burden” of complying with the disclosure requirements to amount to about 68,000 hours annually. After receiving industry comments, however, the FDA has now revised and increased its estimates more than 2,700 percent to more than 1.8 million hours annually. | | | FDA published on Thursday a summary of the agency’s notable 2021 actions. On Wednesday, FDA issued a final rule that revises how denials and approvals of premarket approval applications and humanitarian device exemption applications are announced. They no longer will be published quarterly in the Federal Register but instead will be posted on FDA’s website. Also on Wednesday, FDA published a final rule revoking regulations governing human tissue for transplantation and human dura mater (tissue that helps protect the brain and spinal cord)from before 2005. “We do not believe there are currently any tissues intended for transplantation remaining in inventory that were recovered prior to May 25, 2005, that would be subject to these regulations,” the final rule states. | | | | A message from the Pharmaceutical Care Management Association: With Congress poised to fully repeal the rebate rule and prevent significant increases in both Medicare beneficiary premiums and Medicare Part D program costs, pharmaceutical industry representatives are once again attempting to divert attention by suggesting so-called point of sale rebate policies that would undo this progress. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
