Morning Briefing
Summaries of health policy coverage from major news organizations
Lawmakers, Advocates Accuse Pharma Of Trying To Hijack Opioid Bill With 'Doughnut Hole' Change
The New York Times: Drug Industry Tries To Slip $4 Billion Windfall Into Opioid Bill
Drug companies usually get what they want in public-policy battles on Capitol Hill, but a move by the pharmaceutical industry to grab $4 billion from the federal Treasury in a bill that is supposed to address the nation’s deadly opioid epidemic is meeting fierce resistance. At issue is a small measure that the Pharmaceutical Research and Manufacturers of America, or PhRMA, has deemed a “technical correction” to a bipartisan budget law signed by President Trump in February. The law required drug manufacturers to provide deeper discounts to Medicare beneficiaries whose spending on prescription drugs falls within a range called the coverage gap, or the “doughnut hole.” The discount, now 50 percent on brand-name drugs, is set to rise next year to 70 percent. (Pear, 9/24)
In other pharmaceutical news —
Stat: Sarepta's Gene Therapy Program For Duchenne Resumes After Clinical Trial Hold Lifted
Sarepta’s early-stage clinical trial for a gene therapy for Duchenne muscular dystrophy is back on schedule, the company announced Monday. The Food and Drug Administration had put the trial on hold in July. The FDA ordered the hold after small fragments of DNA turned up in the treatment, which is being used at Nationwide Children’s Hospital in Columbus, Ohio. The contaminated lot was never used in patients, but the company said it would switch to a higher-grade of plasmids. Sarepta spokesperson Ian Estepan confirmed that the new plasmids are coming from the same supplier — something the company had floated as a possibility this summer. (Sheridan, 9/24)
The Wall Street Journal: Surprise Heart Data Is Just The Beginning For Amarin
It isn’t every morning that a stock triples before breakfast, even in biotech.But that is exactly what happened Monday. Amarin announced stunning results in a clinical trial evaluating its lead drug, Vascepa, in high-risk cardiovascular patients. The company said that patients who took Vascepa in addition to a statin experienced a 25% reduction in risk of a heart attack, stroke or other serious cardiac event, compared with patients who took a placebo instead of Vascepa. Shares were up 230% in morning trading. (Grant, 9/24)
