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It’s early stages yet, but scientists were excited about the possibilities offered by the implant as it would address the problem of patients adhering to a daily medication schedule.
The FDA has issued similar warning letters to smaller businesses, but the warning against Curaleaf is the first since the agency began studying how it regulates CBD. The agency plans to report in the fall on its regulatory approach after holding a public hearing and receiving nearly 4,500 comments.
The bipartisan effort, spearheaded by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), is projected to save the federal government $85 billion on drug spending over the next decade. The long-awaited legislation comes amid mounting pressure for Congress to act on rising drug costs.
“Pharma will argue very hard against drug negotiation of the kind we’re talking about,” said Wendell Primus, House Speaker Nancy Pelosi’s top health care adviser. Progressive House Democrats have been worried for months the plan will not go far enough in taking on drug companies and bringing prices down. Meanwhile, Senate Finance Chairman Chuck Grassley (R-Iowa) refused to comment on a similarly long-awaited Senate package.
It isn’t clear yet what kind of policies Congress is considering that could hurt the pharmaceutical industry’s bottom line, but it has been reported that the reforms could cost the industry $115 billion. In other pharmaceutical news: the CVS-Aetna merger, hep C treatment and prisoners, biotech, and President Donald Trump’s drug pricing strategy.
Barring a settlement, the two counties are scheduled to go to trial in October as the first case among the consolidated lawsuits brought by about 2,000 cities, counties, Native American tribes and other plaintiffs. Recently released data shows just how hard-hit those counties — and the rest of the country — were by the opioid crisis. Media outlets dive into the new data to get a better sense of the roots of the epidemic.
The case centers on 80,000 events Novartis held between 2002 and 2011 that federal prosecutors allege amounted to kickbacks masquerading as educational meetings.
Lauren Sullivan had been trying to appeal UnitedHealth’s initial refusal of the drug for her 21-month-old daughter, Daryn. The girl was running out of time to receive the treatment before her second birthday in October, when the drug has to be administered. The company also approved claims for three other patients. In other news, UnitedHealth beats expectations for the quarter, prompting company to boost earnings guidance.
The common comparison of having increased transparency in drug pricing to forcing car companies to add sticker prices is flawed because it overstates the usefulness of the knowledge by implying that patients have much more power to act — to shop around or negotiate — than they actually do. In other pharmaceutical news: lobbying efforts on Capitol Hill, money for a biotech firm, and a CBO projection on the Senate’s drug pricing bill.
Sen. Bernie Sanders (I-Vt.) invited his fellow presidential candidates to join him in refusing to accept contributions over $200 from political action committees, lobbyists and executives of health insurance and drug companies. But an ABC News review of FEC records identified at least three contributions of more than $200 from two individual donors who could be considered executives at companies in those fields.
The six-week trial was the first of many lawsuits against pharmaceutical companies over what role they played in the opioid epidemic, and the outcome is expected to set the bar for the ones that follow. The judge says he anticipates taking about a month to reach a decision in the case.
A new analysis looks at the reasons FDA officials disregard advice from the expert panel — and much of the time there was a disagreement, the FDA took the more cautious route. Interestingly, the authors also found that disagreement was not more common when panel members had conflicts of interest or when there was more media coverage over the drug.
Former Vice President Joe Biden made a similar vow to voters at an AARP/Des Moines Register forum that then-President Barack Obama made as he was touting the health law. The echo from years past highlights Biden’s strategy of building upon the system already in place that has only grown in popularity in recent years. But it could put him out of step with the mood of the party. “Politically, Biden is trapped by his old job,” said Scott Jennings, an appointee in former President George W. Bush’s administration.
2020 Democratic presidential candidate Sen. Kamala Harris (D-Calif.) also says she would work to close a tax loophole for pharmaceutical companies’ direct-to-consumer advertising expenses, and allow the importation of drugs from Canada.
Opinion writers weigh in on these health care issues and others.
The lawmakers say the pending language in the U.S.-Mexico-Canada agreement “would hinder Congress from taking action to increase competition and enhance patient access to more affordable medicines.”
Sen. Amy Klobuchar, a 2020 hopeful, announced her proposal ahead of an AARP/Des Moines Register forum in Des Moines. “I believe we owe it to our seniors to make sure they have the care and support they need as they get older, and as president, I will prioritize tackling Alzheimer’s, strengthening health care and retirement security, and reducing prescription drug costs,” Klobuchar said.
“They’re going to make the political argument that they’re winning,” said Regina LaBelle, the former chief of staff for the Office of National Drug Control Policy during the Obama administration. “Which they can say, since deaths are down. But I get concerned that we’re going to take our eye off the ball on the broader issue of addiction.” Meanwhile, in a battle over Philadelphia’s safe injection sites, supporters of the facilities get a boost from other states.
President Donald Trump’s drug pricing strategy received its second major blow this week on the announcement that the proposal to eliminate drug rebates in Medicare and Medicaid plans will be withdrawn. In January, HHS Secretary Alex Azar said that the proposal had “the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever.” But the changes met significant pushback from insurers and hospitals who worried the proposal wouldn’t force drugmakers to lower prices and would likely see higher profit margins from it. Looking forward, Trump will be left considering ideas that are more popular with progressives than his party.
Two decades ago Sen. Bernie Sanders (I-Vt.) took a similar trip with Americans on the hunt for lower drug prices. The trip is scheduled to leave from Detroit two days before the next Democratic presidential primary debates which will be held in that the city on July 30 and 31.