Morning Briefing
Summaries of health policy coverage from major news organizations
Drugmakers Deploy Lobbyists As Battle Over High Prices Moves To State Level
Amid increasing calls for curbs on U.S. drug pricing, some of the most aggressive legislative action is happening at the state level鈥攁nd industry lobbyists are fanning out to fight back. Lawmakers have introduced bills in about 30 state legislatures this year, seeking to regulate drug prices; require manufacturers to justify price increases; or to form purchasing groups with other states to negotiate lower prices, according to the National Academy for State Health Policy, a nonprofit policy group that has drafted model drug-pricing bills for state use. (Loftus, 5/17)
Poll after poll shows Americans are increasingly concerned about the price of prescription drugs. With each new survey, the debate about importing drugs from Canada seems to gain steam. At least four different bills聽have been introduced this year in Congress, and while the fate of legislation to replace the Affordable Care Act dominates the agenda on Capitol Hill, buying drugs across the border is an idea that won鈥檛 go away. (Sheridan, 5/11)
There鈥檚 no shortage of ways to rank pharma CEOs: Drug sales. Corporate profits. Even haircuts. Here at STAT, we chose to look at it from a shareholder鈥檚 perspective. We calculated shareholder returns over the past three years at the 25 biggest drug companies in the world. Then we compared that with CEO compensation. Five outliers popped out: chief executives who聽got raises well out of step with what they delivered to investors. (Garde, 5/16)
Branded drugmakers weren't the only ones working through a tumultuous 2016. Generics companies faced pricing pressure, too. And while branded companies suffer pricing pain on costly cutting-edge therapies, generics outfits feel the pinch with already-thin margins, making pressure all the more agonizing.How is the industry responding? By consolidating and hoping to save money, for one. Take a look at FiercePharma's 2014 ranking, and it's clear that some companies have made leaps too big to depend on organic growth alone. (Sagonowsky, 5/16)
Could changing up regulatory requirements for Alzheimer鈥檚 drugs help give desperate patients new options for treatment? A group of researchers and patient advocates think so. They authored a paper that argues that the Food and Drug Administration should evaluate Alzheimer鈥檚 drugs for efficacy in either cognition or function 鈥 but not both. Efficacy and cognition are the main endpoints measured in Alzheimer鈥檚 disease. The hallmark of cognitive impairment is memory loss, while functional impairment involves losing the ability to perform tasks of daily living 鈥 from reading to going to the bathroom to getting dressed in the morning. Currently, FDA expects drugs to improve both cognition and function. (Keshavan, 5/15)
Desperate patients are swapping pricey pharmaceutical drugs on Facebook. Doctors say it's dangerous. But when you need a drug every day to survive, you're going to find a way to get it. It shouldn't be that surprising. You can buy, sell or trade almost anything on Facebook, from designer sneakers to unwanted fishing boats to antique medical cots. Now, even life-saving insulin. (Popken, 5/11)
Roughly 60,000 older Missourians will lose state aid to help them pay for prescription drugs starting in July. But lawmakers hope the cut won鈥檛 be permanent. Seniors who earn less than 85 percent of the federal poverty level, or roughly $10,000 a year for an individual, qualify for both Medicaid and Medicare. (Hancock, 5/11)
Priced at $10,000 per person, the cost totaled roughly $10 billion during that time. To some, this would appear to be a bargain for a drug that combats a pernicious disease, yes? But what if it turns out the drug later failed yet another trial and patients with a mild form of Alzheimer鈥檚 weren鈥檛 helped, after all? The money 鈥攎uch of it spent by Medicare 鈥斅爓ould have been wasted and patients鈥 hopes dashed. (Silverman, 5/12)
Upon receiving information that聽Aspen Pharmacare has taken steep price increases on lifesaving cancer meds in Europe and threatened to pull its products in order to get the hikes through, EU聽antitrust regulators have pledged to take a close look at the South African drugmaker鈥檚 business practices. Europe鈥檚 competition authority opened聽an investigation into Aspen on Monday, seeking to learn whether the company 鈥渁bused a dominant market position in breach of EU antitrust rules,鈥澛燼ccording to a release. It noted this is the first time it has looked聽into excessive pricing in pharmaceuticals. (Sagonowsky, 5/15)
That is the lesson that the management at Vikshara Trading & Investments learned the hard way when the company tried to forestall an agency inspection last year by insisting that its workers were on strike and its plant in Gujarat, India, was inaccessible. But were they really on strike?...A year ago, the FDA scheduled an inspection, but last June, Vikshara said employees went on strike and blocked the entrance to the facility. As a result, the agency canceled a planned June 27 inspection. Last July, Vikshara said the strike was ongoing and, in August, provided purported evidence, such as employee resignation letters and a photograph of striking employees blocking the entrance. (Silverman, 5/9)
An aspiring biosimilar manufacturer is employing a citizen鈥檚 petition in a novel way in hopes of setting regulatory approval standards. In a May 3 letter, Apotex asked the Food and Drug Administration to set a specific requirement for other biosimilar companies that, depending upon what the agency decides, may serve as a barrier to regulatory approval of their treatments. (Silverman, 5/11)