Feds want better fentanyl screening tools

Presented by Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jun 13, 2023 View in browser   By David Lim and Katherine Ellen Foley Presented by Pharmaceutical Care Management Association With Megan R. Wilson, Josh Sisco and Ben Leonard Driving the day Test strips that detect contaminated drugs can help reduce overdoses in the U.S., say the FDA and NIH. | Guillermo Arias/AFP via Getty Images FDA, NIH WANT IMPROVED TEST STRIPS — Top government health officials are calling for new research into the feasibility of deploying test strips that quickly and accurately identify fentanyl and other dangerous substances like xylazine. “Few studies have evaluated the objective performance of this approach to drug checking,” FDA Commissioner Robert Califf wrote in The New England Journal of Medicine. He co-authored the article with National Institute on Drug Abuse Director Nora Volkow, acting NIH Director Lawrence Tabak and other public health officials. Testing tools capable of analyzing drugs before consumption fall outside the definition of FDA-regulated medical devices, the officials note. But they said the FDA “would welcome the opportunity to work with test-strip manufacturers” that develop products to test people in clinical settings that can help guide treatment decisions. Nabarun Dasgupta, an innovation fellow at UNC Chapel Hill University’s public health school, told Prescription Pulse that fentanyl test strips are “quite useful” for stimulant users but cautioned the biggest problem with fentanyl test strips is that they too often falsely indicate that a drug contains fentanyl when it doesn’t. “If you have too many false positives, then people lose faith [in] the test,” Dasgupta said. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. We welcome the rain after a smoky week. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Katherine, who reports on the Alzheimer's drug Leqembi, which the FDA is considering for traditional approval and what that could mean for patients. Listen to today’s Pulse Check podcast A message from Pharmaceutical Care Management Association: Don’t be fooled by Big Pharma’s deceptive smoke-and-mirrors scheme. While pharmacy benefit companies lower drug costs for patients, Big Pharma wants to avoid being held accountable for blocking competition and keeping drug prices high. Reject Big Pharma’s smoke and mirrors and hold them accountable. Get the facts.   Eye on the FDA The FDA will consider this week which virus strain should be included in the next Covid vaccine. | Frank Augstein/AP Photo FALL COVID BOOSTER UNDER REVIEW — On Thursday, the FDA’s independent advisers will discuss and recommend which strain of SARS-CoV-2 should be included in the newest Covid-19 booster to be rolled out before fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does. FDA eyes XBB lineage: FDA staff scientists said the updated boosters should offer protection against a widely circulating subvariant of Omicron called the XBB lineage, according to FDA documents published Monday. Earlier this month, the XBB lineage made up more than 95 percent of Covid cases worldwide, and animal data shows that vaccination against one sublineage in the XBB family produces similar immune responses against other sublineages.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     In Congress GOP SEEKS DRUG SHORTAGE INFO — Top Republican lawmakers have requested nationwide data from policy experts on the scope of drug shortages. They’re also asking them how federal agencies can address the market forces that underlie shortages, whether the Inflation Reduction Act might worsen generic drug shortages and more. “The role of key intermediaries, including wholesalers and group purchasing organizations, may also warrant attention as policymakers look to understand the economics shaping shortage dynamics, particularly in light of the high market concentration among these entities,” wrote Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, and Mike Crapo (R-Idaho), ranking member of the Senate Finance Committee, in the request for information by July 7. ONCOLOGY FLY-IN — More than 120 nurses, caregivers, patients and oncologists plan to hit the Hill on Tuesday as part of the Community Oncology Alliance’s advocacy day, Megan reports. They have hundreds of meetings scheduled with lawmakers and congressional staff, pushing for policies that would crack down on pharmacy benefit managers, the pharmaceutical middlemen that manage prescription drugs for health insurers. Lawmakers in both parties in the House and Senate have held hearings and proposed legislation that would compel PBMs to be more transparent about their business practices, particularly how the companies derive their profits. “The stars seem to be aligning for PBM reform and oversight in Washington,” said Aaron Cohen, a spokesperson for the group. “The time is ripe for action, and COA advocates will make sure Congress doesn’t miss this opportunity.” FDA APPROPRIATIONS SCHEDULED — Late Monday, the House Appropriations Committee announced it will mark up the fiscal 2024 FDA funding bill on Wednesday at 10 a.m. EDT.   A message from Pharmaceutical Care Management Association:   In the Courts GOP LAWMAKERS BACK ILLUMINA — A group of 34 Republican lawmakers, including Sens. Bill Hagerty (R-Tenn.) and John Kennedy (R-La.), are urging the U.S. Court of Appeals for the Fifth Circuit to uphold gene-sequencing giant Illumina’s takeover of cancer test-maker Grail. The FTC “is acting as the potentate that Congress expressly sought to avoid creating — able to arbitrarily choose winners and losers and decide the face and fate of an entire industry sector,” the lawmakers said in their amicus brief, Josh reports. How we got here: The FTC staff sued to block the deal in 2021 but lost an administrative trial in the agency’s in-house court last year. That ruling was overturned by the FTC’s four commissioners in April. Now, the companies have appealed, challenging both the ruling against the merger and the constitutionality of the FTC’s decision-making process. Illumina and Grail’s appeal is set to be heard by the Fifth Circuit in August, but a ruling could be moot. Illumina CEO Francis deSouza resigned over the weekend, following a bruising proxy battle with activist investor Carl Icahn, who criticized the company’s lengthy and expensive battle to buy Grail. The deal also faces multiple legal battles in Europe, and regulators there may force Illumina to divest Grail. But with deSouza out, Illumina loses its biggest champion for the deal.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     Around the Agencies HHS EXPANDS PART D PREMIUM HELP — HHS announced measures Monday to reduce prescription drug costs, targeting low-income older adults and people with disabilities, Ben reports. HHS’ Administration for Community Living will undertake “targeted efforts” to reach and enroll people eligible for the Extra Help program, which was expanded beginning Jan. 1 under the Inflation Reduction Act. The program aids the elderly and people with disabilities in paying for their Medicare Part D drug coverage premiums. CMS is also releasing an outreach toolkit to boost awareness about the program. Tobacco FDA TO EXAMINE SYNTHETIC COOLANTS — The FDA seeks to hire an external company with expertise on the potential toxicity of synthetic chemicals that replace menthol flavoring in e-cigarettes. Pharma Moves Mary Grealy will retire from her position as president of the Healthcare Leadership Council at the end of the year. Document Drawer The FDA released draft guidance aimed at helping tattoo ink manufacturers and distributors reduce contamination risk and their potential adverse health impacts. The American Academy of Neurology on Monday formally requested CMS reconsider its national coverage determination for monoclonal antibodies that target a certain protein in the brain for the treatment of Alzheimer’s disease. Medical device industry group AdvaMed met with the White House Office of Information and Regulatory Affairs on Monday to lobby for an expansive approach in CMS’ pending transitional coverage for emerging technologies notice, according to a meeting disclosure. Senate HELP Committee Chair Bernie Sanders (I-Vt.) released on Monday a majority staff report examining the role of taxpayer funds in drug development and the much higher prices U.S. patients pay for drugs compared with what others pay in other developed nations. A message from Pharmaceutical Care Management Association: Big Pharma’s smoke-and-mirrors scheme is designed to shirk responsibility for their abuse of the patent system and keep drug prices high. It’s time to reject Big Pharma’s smoke and mirrors, and protect the pharmacy benefits that provide savings and choices for patients and employers. Get the facts.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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