Supreme Court Justices Seem To Side With Drugmakers Over Its Popular Strategy To Ward Off Patient Lawsuits
The drugmakers argue that the FDA limits their ability to warn patients about the side effects of their medicine, while patients say that pharmaceutical companies should be more transparent about the potential risks of their medicines. The Supreme Court heard oral arguments on Monday.
Stat:
SCOTUS Seems Unlikely To Overhaul Popular Drug Industry Legal Strategy
Several Supreme Court justices seemed to side with the drug industry in a case that examined a popular defense that companies use to ward off patient lawsuits. They heard oral arguments Monday in a case that has high stakes for pharmaceutical companies, which often wriggle out of patient lawsuits by arguing that the Food and Drug Administration limits their ability to warn patients about the side effects of their medicines, therefore absolving them of responsibility to do anything other than exactly what the FDA mandates. Patients, on the other hand, want drug makers to be more explicit about the potential risks of their medicines and argue that state law supports them. (Swetlitz, 1/7)
Politico Pro:
Justices Appear Divided In Merck Drug Labeling Case
At issue in Merck v. Albrecht is whether FDA’s final say over the content of drug warning labels insulates drugmakers from failure-to-warn lawsuits in state courts. The agency in 2009 rejected Merck's attempt to update the warning label of its osteoporosis drug Fosamax to reflect the risk of bone fractures. Justices will have to decide if Merck's warning was deliberately vague or if FDA was reluctant to warn of serious fractures. (Karlin-Smith, 1/7)
In other pharmaceutical news —
ProPublica/The New York Times:
Top Cancer Doctor, Forced Out Over Ties To Drug Makers, Joins Their Ranks
Dr. José Baselga, who resigned his position as the top doctor at Memorial Sloan Kettering Cancer Center after failing to disclose millions of dollars in payments from drug companies, is now going to work for one of them. AstraZeneca, the British-Swedish drug maker, announced on Monday that it had hired Dr. Baselga as its head of research and development in oncology, a newly created unit that reflects the company’s shift toward cancer treatments, one of the hottest areas in the drug industry. (Thomas and Ornstein, 1/7)
The New York Times:
Court Rejects Trump’s Cuts In Payments For Prescription Drugs
A federal court has rejected President Trump’s first major effort to cut payments for prescription drugs, saying the administration went far beyond its legal authority. The Trump administration made a “drastic departure from the statutorily mandated rates” when it reduced payments to hospitals for drugs given to Medicare beneficiaries in outpatient clinics, Judge Rudolph Contreras of the Federal District Court here said in the decision, issued late last month. Alex M. Azar II, the secretary of health and human services, “may not end-run Congress’s clear mandate,” the judge said. (Pear, 1/7)
Stat:
People Who Don’t Respond To HIV Meds Overlooked By Pharma, Researchers
[Nelson Vergel] is what’s known as an immunologic non-responder (INR) — someone whose immune system does not rebound even after years of antiretroviral therapy. ...Nobody knows exactly how many INRs like Vergel there are, but they are likely to number fewer than 200,000 in the U.S., where there are roughly 1.1 million people with HIV. (The proportion of INRs is likely to be higher elsewhere in the world, where the burden of HIV is higher and access to drugs more difficult.). The small number in the U.S. may paradoxically offer the best hope for non-responders — the cutoff for orphan status, a special designation that gives drug makers incentives to develop medications for rare diseases, is 200,000 people. (Mandavilli, 1/8)