Gottlieb, McClellan push for FDA regulatory reforms

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Oct 14, 2022 View in browser   By David Lim and Lauren Gardner In Congress Dropping reforms that would modernize the FDA's oversight of cosmetics, as well as dietary supplements and diagnostic tests, doesn't bode well for consumers, two former FDA commissioners warn. | Brendon Thorne/Getty Images EX-COMMISSIONERS PLUG FORMER UFA SUPER RIDERS — The decision by lawmakers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from the recent FDA user fee reauthorization constitutes a "profound missed opportunity" to strengthen the agency's ability to protect consumers, former FDA Commissioners Scott Gottlieb and Mark McClellan wrote in a JAMA piece published Thursday. The ex-FDA chiefs acknowledged that congressional leaders have indicated intent to further negotiate the provisions and potentially add them to an end-of-year omnibus package to fund the government, but Gottlieb and McClellan warned such a possibility is unlikely in the absence of broad bipartisan support. "Both Democrats and Republicans have raised legitimate concerns, as have some stakeholders, but the relatively small issues that remain could be worked out through the Congressional committees that authorize the FDA," Gottlieb and McClellan wrote. "Congress should seize this opportunity to achieve long-awaited reforms that will modernize FDA's regulation, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable." AdvaMed CEO Scott Whitaker told reporters on Thursday that the medical device lobby is still pressing for diagnostics reform — known as the VALID Act — to be added to the end-of-year legislative package. Academic medical centers lobbying for carve-outs to the legislation represent one of the big issues still being negotiated. "The important thing in VALID and in diagnostics reform is that the regulatory environment needs to be pretty consistent across the entire industry," Whitaker said. "And patients deserve the right to understand whether a product has gone through the same level of scrutiny when they're relying on it for a diagnosis." In June, the Association of American Medical Colleges wrote a letter to lawmakers, asking them to "explicitly exempt" academic medical laboratories from the VALID Act). "Many academic centers are understandably reluctant for their laboratory-developed tests to be subject to additional regulation," the Gottlieb and McClellan op-ed said. "But institutions that demonstrate they are overseeing the safety and reliability of their laboratories would have a streamlined regulatory path not available today. The legislation would also grandfather in most of the existing laboratory-developed tests." IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Your host drafted Joel Embiid with the fourth overall pick in his (mostly) health reporter fantasy basketball league. 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). TODAY ON OUR PULSE CHECK PODCAST, Erin Banco talks with Megan Wilson about why Japan's smallpox doses could be crucial for low- and middle-income countries. Plus, Rep. Elissa Slotkin told Alice Miranda Ollstein why she's still frustrated with Democratic leadership over lack of preparation on abortion access. Listen to today's Pulse Check podcast Eye on the FDA The FDA says the supply of the prescription drug Adderall isn't sufficient to continue to meet U.S. market demand. | Mario Villafuerte/Getty Images ADDERALL IN SHORTAGE — The FDA on Wednesday added the immediate-release formulation of amphetamine mixed salts — commonly referred to by brand name Adderall — to its drug shortage list . The shortage is driven by "ongoing intermittent manufacturing delays" at Teva, a major manufacturer of the drug, used to treat attention deficit hyperactivity disorder and narcolepsy, according to the agency. "Other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers," the FDA said in an email on Thursday. "Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts available to health care professionals and their patients for amphetamine mixed salts' approved indications." Teva spokesperson Kelley Dougherty said in an email that patients may experience temporary back orders. The company expects inventory to improve "in the coming months." The FDA's drug shortage list indicates recovery is expected by October 2022 to March 2023 for various formulations of the medication. "We are fully committed to uninterrupted supply and continuing to manufacture and distribute as much product as possible each day," Dougherty said. "We are working closely with our manufacturing facility and the DEA to see what additional volume we may be able to support in the future."   TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO's must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING.     Coronavirus PFIZER'S EARLY READ ON OMICRON BOOSTER DATA — Early data from a clinical trial of the Pfizer-BioNTech Omicron-targeting Covid-19 booster found it produced a "substantial increase" in adults' neutralizing antibody response above pre-booster levels, the companies said Thursday. That's based on serum measurements taken seven days post-immunization. Responses in adults ages 18 to 55 were similar to those seen in individuals older than 55, the companies said. Those 55 and older who received the original vaccine formula as a booster showed "more limited increases" in antibody responses to the BA.4 and BA.5 subvariants, they said, suggesting the updated shot will "provide better protection" for younger and older adults against the circulating strains. FDA AUTHORIZES BIVALENT OMICRON BOOSTERS FOR KIDS — The FDA announced Wednesday it granted emergency use authorization to Pfizer-BioNTech's and Moderna's Omicron-targeting Covid-19 booster shots for children as young as ages 5 and 6, respectively, Lauren reports. And CDC Director Rochelle Walensky subsequently formalized a recommendation for their use in children and adolescents. But only 39 percent of kids ages 5 to 11 years old have received at least one dose of the two-dose primary Covid vaccine series, according to CDC data. And just 5 percent of the eligible U.S. population has received the updated bivalent booster. The CDC's Advisory Committee on Immunization Practices is scheduled to meet on Oct. 19 to discuss Covid-19, pneumococcal and chikungunya vaccines. On Oct. 20, the committee plans to reconvene to discuss respiratory syncytial virus, meningococcal, influenza, dengue and monkeypox vaccines, as well as review revisions to the combined immunization schedule for adults and children. BECERRA EXTENDS COVID-19 PUBLIC HEALTH EMERGENCY — HHS Secretary Xavier Becerra on Thursday signed an extension of the Covid-19 public health emergency declaration, a move that effectively ensures federal measures to respond to the pandemic remain in place into 2023. Industry Intel HRT FILES ROLLING SUBMISSION FOR OTC NALOXONE — Drugmaker Harm Reduction Therapeutics announced Tuesday it filed the first module of a New Drug Application for intranasal naloxone product ReVive as an over-the-counter treatment. The company expects to complete the submission later this year. Quick Hits Device maker Royal Philips announced this week it will write down the value of the company's sleep and respiratory units by 1.3 billion euros, or nearly $1.3 billion, as it continues to work through a recall of sleep apnea devices, The Wall Street Journal's Denise Roland reports. New data released this week show GSK's RSV vaccine was 82.6 percent effective in a late-stage trial with older adults, Reuters' Natalie Grover reports. The FDA on Thursday published final guidance with recommendations for comparability protocols for post-approval changes to chemistry, manufacturing and controls information in drug applications.   STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what's next in health care? Sign up for our Future Pulse newsletter. If you aren't already subscribed, follow this link to start receiving Future Pulse.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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