Morning Briefing
Summaries of health policy coverage from major news organizations
While Drugmakers Lick Wounds From Public Outrage Over Prices, One Company Remains Defiant
Congressional hearings. Federal investigations. Consumer outrage.聽In the wake of developments like these, many drug company executives are laying low. Their favored business models, based on raising drug prices indiscriminately, are now seen as a liability; many pharmaceutical companies are curbing increases on their products and accepting that this once-lucrative jig may be up. (Morgenson, 4/14)
All the recent rancor over drug pricing has led biotech to change its ways.聽Not by making new drugs cheaper, of course, but by holding off on naming a price 鈥 and thus inviting controversy 鈥 until the last possible minute. Nowadays, as soon as a drug wins Food and Drug Administration approval, so begins a debate about whether it鈥檚 worth the thousands of dollars a year new therapies generally cost. And so companies, perhaps mindful of how a few scolding tweets can snowball into a market-moving event, are starting to keep that information under wraps for as long as possible. (Garde, 4/12)
Making money when drug prices were rising was easy. Now comes the hard part.The latest signal: Distribution giant Cardinal Health lowered earnings expectations Tuesday morning and told investors that business wouldn鈥檛 pick up until the middle of 2018. The company is being hit by falling prices of generic drugs, which are expected to decline by a percentage in the low double digits for the fiscal year ending in June. (Grant, 4/18)
In a bid to loosen off-label communications, a congressman quietly introduced a bill late last month that would expand the ability of drug makers to discuss unapproved uses of their medicines with doctors. The legislation, which was proposed by Representative Morgan Griffith (R-Va.), addresses a controversial, if technical term called 鈥渋ntended use.鈥 The Food and Drug Administration maintains that discussion of an unapproved, or off-label use, creates a new intended use for which a drug maker must have regulatory approval. (Silverman, 4/18)
U.S. regulators have approved the first drug for treating a neurological syndrome that causes uncontrollable body movements that can also interfere with speech, swallowing and breathing. The sometimes-disabling disorder, tardive dyskinesia, is caused by some widely used prescription medicines for psychiatric and gastrointestinal disorders. It can surface while patients are on those medicines or years after they stop. It affects about 500,000 U.S. patients. (Johnson, 4/11)
A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerhouse lobbying group that includes聽Eli Lilly, Pfizer and Bayer. A PhRMA senior vice president, Scott LaGanga, for 10 years led the Partnership for Safe Medicines, a聽nonprofit that has recently emerged as a leading voice against Senate bills that would allow drug importation from Canada. (Kopp and Bluth, 4/19)
Abill that was recently introduced in Nevada to fight the cost of diabetes medicines is quickly generating vociferous opposition from several patient organizations, some of which receive financial support from the pharmaceutical industry. The groups include the National Organization for Rare Disorders, Caregiver Voices United, the Myositis Association, the International Pain Foundation, RetireSafe, and the Epilepsy Foundation. And most of their letters, which were sent to Nevada state senators, use nearly identical language in citing concerns. (Silverman, 4/17)
The long and contentious purchase of Alere Inc. of Waltham by Abbott Laboratories appears at hand, after the two health care companies said Friday they have a new deal that lowers the takeover price by $500 million. The amended takeover, under which Abbott will pay $51 for each share of Alere, is valued at $5.3 billion, down from the $5.8 billion the parties had initially agreed to in February 2016. (Weisman, 4/14)
Eli Lilly鈥檚 path to what looked like a surefire blockbuster got derailed by an unforeseen FDA rejection, clouding the future of a drug the company viewed as a pipeline in a pill. The Food and Drug Administration declined to approve Lilly鈥檚聽baricitinib, an oral treatment for rheumatoid arthritis. According to Lilly, the agency wants to see more clinical data to determine the safety and ideal doses聽for the drug. Lilly didn鈥檛 disclose whether that means it will have to recruit and run new studies of the treatment, but if so, a resubmission could be delayed by months. (Garde, 4/14)
In September 2015, Satish Mehta, the billionaire chief executive of the Indian drug company Emcure Pharmaceuticals, wrote an effusive email congratulating Jeffrey Glazer, the CEO of his U.S. crown jewel, Heritage Pharmaceuticals, on a job well done. "In a short span of 4.5 years, you have taken Heritage to another level," Mehta wrote, adding that he considered Glazer to be "an integral part of our family." (Vardi and Karmali, 4/18)
The Senate unanimously approved a measure Monday to create a prescription drug-share program that would allow donations of packaged cancer drugs, but not opioids. The bill would allow nonprofit organizations to donate and redistribute prescription drugs still in their manufacturer packaging to people who don't have health insurance and meet other criteria. Multiple senators said the medication will largely come from long-term care facilities, which throw away a large amount of unused medication. (Lowary, 4/17)
The legislation, which was introduced by Pennsylvania Representative Patrick Meehan, a Republican, was co-sponsored by two North Carolina congressmen, Republican George Holding and Democrat G.K. Butterfield. In their home state, CROs employ some 24,000 people. Today, North Carolina is home to 152 CROs, which include powerhouses like PPD, PRA Health Sciences, and INC Research, as well as smaller outfits like Rho and Cato Services. CROs聽鈥 which are also often referred to as contract research organizations聽鈥 are a boon to North Carolina鈥檚 life science industry, which raked in nearly $2.2 billion in state and local government tax revenues in 2016, according to an economic impact report from the North Carolina Biotechnology Center. (Broadfoot, 4/18)