| | | | |  | | By Lauren Gardner | Presented by Idorsia Pharmaceuticals | | | | | | 
AstraZeneca says Medicare's drug price negotiations program jeopardizes rare disease drug development. | Lisa Maree Williams/Getty Images | DRUG PRICE TALKS IN COURT AGAIN — The Justice Department heads to federal court in the state where President Joe Biden resides this week to defend its Medicare drug price negotiations program. Oral arguments in AstraZeneca’s case in the U.S. District Court for the District of Delaware will be the first concerning the merits of the pharmaceutical industry’s efforts challenging the program’s constitutionality. A September hearing in the U.S. Chamber of Commerce’s challenge to the law in an Ohio federal district courtroom concerned whether the negotiations should be halted while the litigation plays out; that bid was denied. Rare disease focus: The U.K.-based company, which makes the best-selling diabetes drug Farxiga, will argue that the program jeopardizes rare disease drug development — a novel focus among the nine lawsuits lodged against the negotiations mandated by the Inflation Reduction Act. Drugs approved with so-called orphan designations treat small populations, so their makers are less able to recoup research and development costs. The IRA exempts orphan drugs from negotiations when they first receive orphan designations. But the products can be subject to bargaining if they receive additional designations for orphan diseases. Not convinced: The DOJ dismissed AstraZeneca’s orphan drug argument as speculative. “The possible future selection of an orphan drug (in particular, one manufactured by AstraZeneca) is highly uncertain, because (in Plaintiffs’ own words) ‘the patient populations for these diseases are so small,’” the government said in one of its filings. Constitutional conundrum: The drugmaker also contends that the negotiations program is unconstitutional because it violates the Fifth Amendment’s due process clause by avoiding notice-and-comment rulemaking — an argument shared by some other manufacturers taking the Biden administration to court. The DOJ maintains that the due process arguments fail because Medicare participation is voluntary — no matter how integral the program may be to a company’s business model. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you going to Janet Woodcock’s retirement party this week? Share the details! We’ll keep you anonymous. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. Learn more. | | | | | | | 
Philips, the company behind a global recall of sleep apnea machines, said it will stop selling the devices in the U.S. for now. | Peter Dejong/AP | PHILIPS, FEDS FORGE POST-RECALL PLAN — Health tech company Philips won’t sell new sleep apnea devices in the U.S. until it meets conditions outlined in a deal with the DOJ, the company said Monday. The consent decree, which must be finalized and then approved by a U.S. court, comes nearly three years after subsidiary Philips Respironics recalled millions of its medical devices that help patients breathe during sleep. The foam used in the devices to muffle sound and vibration can break down, which can lead to patients inhaling chemicals or pieces of foam. SCOTUS SETS ABORTION PILL ARGUMENTS — The Supreme Court on Monday scheduled oral arguments for March 26 in a case about patient access to medication abortion, POLITICO’s Kierra Frazier and Alice Miranda Ollstein report. That means the high court will likely make another consequential decision on U.S. reproductive health policies in June, two years after the justices overturned Roe v. Wade. Mifepristone, the pill in question, is approved for use up to 10 weeks of pregnancy. The Supreme Court could roll that back to seven weeks, require an in-person doctor visit to obtain the medication and unravel the FDA’s efforts to expand access by allowing pharmacists to provide it. A lower court’s ruling last year “threatens profound harms to the government, the healthcare system, patients and the public” and would “upend the regulatory regime for mifepristone,” the DOJ said earlier this month in a brief urging the Supreme Court to reverse the opinion.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | | | | PHARMA CAVES UNDER SUBPOENA THREAT — ICYMI Friday, the CEOs of Johnson & Johnson and Merck agreed to testify on prescription drug prices before the Senate HELP Committee next week. They, along with the head of Bristol Myers Squibb, will appear before the senators on Feb. 8 to answer questions about why Americans pay far more for drugs than those in other developed nations. The companies relented after Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, indicated he had enough support from his colleagues on the panel to subpoena their testimony.
| | | | A message from Idorsia Pharmaceuticals:   | | | | | Katlin McKelvie has joined Gibson, Dunn & Crutcher as a partner in the law firm’s FDA and health care practice group. She was previously deputy general counsel at HHS and held positions at the FDA and on the Senate HELP Committee. Ian Simon, the assistant director for health strategy and biopreparedness at the White House’s Office of Science and Technology Policy, has been named director of HHS’ Office of Long Covid Research and Practice. He was previously a senior adviser to Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases. The nonpartisan nonprofit Alliance for Health Policy has hired Claire Sheahan as its next president and CEO. She’s previously worked for the advocacy group Association for Accessible Medicines, health care consulting firm Avalere and drugmaker Alexion Pharmaceuticals.
| | The Biden administration and the pharma industry are in lockstep on one topic, unlike their battles in the U.S. They’re united in blocking an effort to allow developing countries access to U.S. companies’ patents for drugs and vaccines when the next pandemic emerges, POLITICO’s Carmen Paun writes. STAT describes how the high prices for two gene therapies treating sickle cell disease are challenging the budgets of state Medicaid programs. Novo Nordisk’s decision to discontinue a long-acting form of insulin in the U.S. is causing patients to scramble for alternatives, USA Today reports.
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. These newer medications, known as dual orexin receptor antagonists, or DORAs, block the binding of the wake-promoting neuropeptides orexins and turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.
In 2023, Idorsia Pharmaceuticals, which markets one of the DORA drugs, filed a Citizen Petition urging the Drug Enforcement Administration (DEA) to de-schedule the DORA class of chronic insomnia medications based on a review of available data and real-world evidence. With addiction becoming an increasing problem in America, Idorsia is hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which are frequently abused or misused, to treat insomnia. Learn more. | | | | | The FDA published guidance Monday offering recommendations to makers of gene-therapy products that use genome editing. The guidance comes weeks after the FDA approved the first gene-editing treatment, which targets sickle cell disease. The FDA issued draft guidance Monday providing recommendations on a standardized approach for medical product makers to collect and report race and ethnicity data from clinical trials. The FDA released best practices Monday for agency staff conducting postmarketing surveillance of the safety of drugs and biologics.
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