This Drug Used To Be $50 A Bottle, Now It Goes For $15,000. Lawmakers Want Answers.
The drug, Keveyis, received orphan status in 2015, which triggered a huge price spike. Now lawmakers are seeking an analysis from the company about why it went up so much. In other pharmaceutical news: a report finds that drugmakers have avoided more than $1.3 billion in Medicaid drug rebates between 2012 and 2016; the president's desire to cut regulations could actually backfire at the FDA; and a settlement over drug coupons could be the start of a broader crackdown.
Lawmakers Demand Answers On A Huge Price Hike For An Old Drug
Several lawmakers are targeting the sky-high price of an old drug that cost just $50 for a bottle of 100 pills a little more than a decade ago but goes for $15,000 today. The drug, which was once called Daranide and is now known as Keveyis, was originally approved in 1958 to treat glaucoma, although it was more recently approved to combat periodic paralysis and received orphan status. This means the drug was endorsed for a rare disorder affecting a small group of people — about 5,000 in the U.S. — and also several years of market exclusivity. (Silverman, 12/20)
Drug Makers Dodged $1.3 Billion In Payments To Medicaid, Report Finds
Drug makers dodged more than $1.3 billion in Medicaid drug rebates between 2012 and 2016 because they inappropriately or mistakenly miscategorized brand-name products as generics, which qualify for lower rebates. Some $1.17 billion of that figure was associated with miscategorizations for just two drugs, according to a new report from the Health and Human Services Department’s independent inspector general, which did not name the products or their manufacturers. Had the 10 most expensive of the drugs been classified appropriately, state Medicaid programs would have saved that $1.3 billion figure, the report said. Instead, they collected just $199 million for those drug rebates. (Mershon, 12/20)
Trump's Zeal For Deregulation Could Gum Up The FDA, Experts Say
President Trump quite literally cut a stretch of red tape last week to emphasize his slash-and-burn stance on government deregulation. But what would sweeping regulatory change mean for public health? And could changes by his administration wind up creating even more red tape? A new analysis in the New England Journal of Medicine suggests that stifling an agency’s rulemaking ability “could have potentially disastrous consequences” for the Food and Drug Administration and other agencies that protect public health. Proponents of deregulation, however, say that the current regulatory system hampers economic growth and puts the U.S. at a competitive disadvantage with foreign competitors. (Keshavan, 12/20)
Justice Settlement May Be First Of Many On Drug Coupons
United Therapeutics has reached a $210 million settlement with the Justice Department over its handling of a drug coupon program, marking the start of what could be a broader crackdown on pharmaceutical industry-funded copay charities. At least four other major drugmakers — Jazz Pharmaceuticals, Celgene, Pfizer and Gilead — have received subpoenas recently about their relationships with charities. (Karlin-Smith, 12/20)