Paying Peter with patent proceeds

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jun 21, 2024 View in browser   By Lauren Gardner and David Lim Driving The Day Congress has an estimated $3 billion in savings on proposed legislation that could be used to fund other health care measures. | Anna Moneymaker/Getty Images WAIT WAIT … DON’T TELL ME! Now that everyone has digested the news that Congress has some $3 billion in estimated savings on proposed legislation it could use to pay for other health care legislation, advocacy groups and pharma industry experts are weighing how exactly such an effort might play out on Capitol Hill. Lauren quizzed David about the possible ramifications of a recent Congressional Budget Office score for a bipartisan bill that would prohibit a practice known as product-hopping: Does the updated CBO score improve the chances of this bill — or others like it — advancing this Congress? Proponents certainly think that the lame-duck period after the election is an opportune time for a health care package, in part because a short-term funding agreement for community health centers is set to expire at the end of the year. It could also help pay for other legislation to address drug shortages, reform pharmacy benefit manager practices, extend telehealth policies, address insulin costs or boost physician payments. David Mitchell, president of advocacy group Patients for Affordable Drugs, told me that Congress has roughly $5 billion that it can use to pay for other priorities when you add savings from two other health care-related bills CBO scored earlier this year. What exactly would the bills do?  The first, the Affordable Prescriptions for Patients Act of 2023, would prevent firms from marketing a reformulation or another drug to treat the same or similar condition and then discontinuing or disadvantaging the first medicine. It also would limit the number of patents companies can assert are infringed upon when making, importing or marketing a copy of complex drugs. The Preserve Access to Affordable Generics and Biosimilars Act — which seeks to clamp down on agreements made between brand and generic companies that delay market entry of generic drugs — would save more than $1.6 billion over a decade, according to the CBO. And the CBO found that the Stop STALLING Act would save roughly $400 million over a decade by allowing the Federal Trade Commission to take civil action against people or companies that petition the FDA with the intent to delay approval of generic competition. The trio of bills are all clearly health care-related legislation, according to Remy Brim, a former senior HELP Committee staffer for Sen. Patty Murray (D-Wash.) and who now lobbies at BGR for several companies. “If I was leadership staff, I would say that this is a health care pay for, this is for health care stuff,” Brim told me. What’s next? Bill proponents now need to convince congressional leadership that the measures warrant inclusion in an end-of-year package — and health staffers will have to fight to ensure they’d be allocated to offset health care-related priorities. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re not-so-patiently waiting for the Supreme Court to issue more health care decisions — are you? Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     Eye on the FDA Medical groups are pressing the FDA to lift mifepristone restrictions. | Anna Moneymaker/Getty Images MIFEPRISTONE REMS PRESSURE — Several leading medical associations urged the FDA this week to shed remaining regulatory restrictions on the use of the medication abortion drug mifepristone. But the process for how that could happen is more complicated than the agency simply proposing policy changes. The American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Medical Association and other organizations want the FDA to “permanently remove” the remaining risk evaluation and mitigation strategies, or REMS, imposed on the drug. Under the Obama and Biden administrations, the FDA approved the drug for use up to 10 weeks of pregnancy from seven weeks, ended the in-person prescribing requirement and allowed brick-and-mortar pharmacies to dispense it. But the drug still must be prescribed and dispensed by providers and pharmacists certified under the REMS to do so. But drug sponsors are generally on the hook for prodding the FDA to make changes to REMS. The FDA can require a manufacturer to submit a proposed REMS change if it determines a modification is needed to ensure a drug’s benefits outweigh its risks or to lessen the compliance burden on health care providers, according to 2020 agency guidance. Danco Laboratories, maker of the branded drug Mifeprex, hasn’t submitted a request to the FDA to remove the remaining mifepristone REMS, a company spokesperson told Prescription Pulse. The FDA didn’t respond to a request for comment on ACOG’s statement. ACOG filed a citizen petition in 2022 requesting that the agency ask Danco to file a supplemental new drug application to add miscarriage management to the drug’s labeled indications and to change or eliminate the REMS so they don’t hinder access for that purpose. The agency denied the petition in January 2023. “The REMS requirements do nothing to enhance the safety of an already safe drug; instead, they impose administrative burdens, exacerbate health inequities and lead to delays in care,” ACOG and other groups said earlier this week. UPDATED INTERCHANGEABLE THINKING — The FDA issued updated draft guidance Thursday in its quest to loosen strictures around when and how biosimilar drugs are considered interchangeable with branded products and thus can be swapped without provider intervention. The agency proposes to allow drug sponsors to submit an assessment of why comparative data shows the switching standard for safety and efficacy has been met, an alternative to conducting switching studies to support a bid for interchangeability. It seeks comments by Sept. 20. In the 15 years since Congress established a legal framework to approve biosimilars, the FDA “has gained further experience in evaluating the potential analytical differences between proposed biosimilar products and their reference products and understanding their impact on clinical performance,” it said in the guidance. The FDA has asked Congress to remove the interchangeability distinction for biosimilars, arguing it’s led to confusion over whether the products are as safe and effective as brand-name options. “This should open the door to more competition,” former FDA Commissioner Scott Gottlieb posted on X. WEIGHT-LOSS DRUGS WHO SEMAGLUTIDE WARNING — The World Health Organization issued a warning Thursday about counterfeit diabetes and weight-loss drugs that have entered the supply chain in three countries, including the U.S. Three counterfeit batches of Ozempic, Novo Nordisk’s semaglutide-based medication for diabetes, were detected in Brazil, the U.K. and the U.S. in the fall and winter of 2023. The alert came the same day that Eli Lilly, which makes GLP-1 drugs with a different active ingredient, released an open letter to the public encouraging proper use of its Mounjaro and Zepbound brands — not for cosmetic weight loss, for example — and warning against fake versions of the drug. The drugmaker also sued more wellness centers and other businesses Thursday that it claims are improperly marketing products as either the same as or equivalent to its branded medicines. Research Corner HIV PrEP DEVELOPMENT — An interim analysis of a Phase III trial of a twice-yearly injectable drug by Gilead suggests 100 percent efficacy in preventing HIV in women. The company said Thursday the results are superior to those of its once-daily oral prevention drug Truvada, and an independent panel recommended Gilead unblind the trial to offer the injectable option to all participants. More trials are ongoing.   SUBSCRIBE TO GLOBAL PLAYBOOK: Don’t miss out on POLITICO’s Global Playbook, our newsletter taking you inside pivotal discussions at the most influential gatherings in the world. Suzanne Lynch delivers the world's elite and influential moments directly to you. Stay in the global loop. SUBSCRIBE NOW.     Pharma Moves Tandem Diabetes Care announced Jean-Claude Kyrillos will become chief operating officer of the company effective today. WHAT WE'RE READING A federal indictment against a virtual mental health firm could have cascading effects on tens of thousands of patients who take stimulants such as Adderall, POLITICO’s Ben Leonard reports. Document Drawer The FDA expanded its approval for Elevidys, a gene therapy for Duchenne muscular dystrophy. The drug received traditional approval for individuals 4 years and older with DMD who can walk and have a confirmed mutation in the DMD gene and accelerated approval for people in that same age group who can’t walk. CMS is starting a national coverage analysis for transcatheter tricuspid valve replacement; comments are due in 29 days.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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