From Stat

Supreme Court seems unlikely to overhaul popular drug industry legal strategy

January 7, 2019

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.

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….

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Gottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market

December 11, 2018

FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.

FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.

But in a speech at this week’s FDA/CMS Summit, Gottlieb stopped short of endorsing policies gaining steam on Capitol Hill that would dramatically change how insulin makers do business.

“We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive,” Gottlieb said Tuesday, according to prepared remarks shared with STAT. “These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old….”

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With new drug pricing legislation, Grassley and Wyden hint at the next steps for a powerful Senate committee

December 4, 2018

A powerful, bipartisan pair of lawmakers introduced new legislation Tuesday that would give the government more power to make sure drug companies play by the rules of the Medicaid program.

A powerful, bipartisan pair of lawmakers introduced new legislation Tuesday that would give the government more power to make sure drug companies play by the rules of the Medicaid program.

It’s the first sign of how the duo, Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) intends to use their respective perches at the Senate Finance Committee to lower drug prices. Grassley will chair the committee beginning in January, and Wyden is already its top Democrat. The committee has jurisdiction over Medicare and Medicaid, including oversight of most of the Trump administration’s work to date on the issue of drug prices….

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Democrats took the House. Here’s what it means for health and medicine

November 6, 2018

WASHINGTON — Democrats rode a wave of health care messaging into a majority of the House of Representatives, projections showed Tuesday, propelled by vows to protect Americans with pre-existing health conditions and dramatically lower prescription drug costs.

WASHINGTON — Democrats rode a wave of health care messaging into a majority of the House of Representatives, projections showed Tuesday, propelled by vows to protect Americans with pre-existing health conditions and dramatically lower prescription drug costs.

Some of the winning Democrats highlighted their own health struggles. Others lambasted their Republican opponents for taking money from drug companies and health insurers. The GOP’s steadfast effort to roll back the Affordable Care Act dominated congressional campaigns around the country, and on Election Day, exit polls showed health care was the top concern for voters.

The victory puts Democrats in a far better position to test the far-reaching health care agenda they have campaigned on for well over a year, though their ambitions will almost certainly be curtailed by a Republican-held Senate and President Trump’s White House…

 

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System for reporting suspicious opioid orders repeatedly failed, report finds

July 12, 2018

A Senate report released Thursday lays out systematic failures in the reporting system for suspicious opioid orders, faulting some drug distributors and manufacturers for their roles and criticizing the Drug Enforcement Administration for a years-long lull in enforcement actions.

A Senate report released Thursday lays out systematic failures in the reporting system for suspicious opioid orders, faulting some drug distributors and manufacturers for their roles and criticizing the Drug Enforcement Administration for a years-long lull in enforcement actions.

The findings, the latest in a series of reports from Sen. Claire McCaskill (D-Mo.), the top Democrat on the Senate’s leading oversight committee, pointed in particular to disparities between two leading drug distributors: McKesson and AmerisourceBergen.

The two distributors shipped nearly identical volumes of opioids to Missouri between 2012 and 2017: roughly 650 million doses each….

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