Welcome to the Fierce Pharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
It's no secret that the drug industry isn't thrilled with the Trump administration's last-ditch push to bring down drug prices, including an order allowing drug imports from Canada. Now, PhRMA is taking its objections to court.
After the administration unveiled its importation executive order in final form in September, PhRMA and other groups sued the Department of Health and Human Services (HHS) last month arguing the measure violates the Food, Drug, and Cosmetic Act.
The lawsuit claims HHS’ importation effort increases risks for the U.S. drug supply chain and forces companies to disclose trade secrets, Bernstein analyst Ronny Gal wrote in a recent note to clients.
While the lawsuit “touches on multiple points,” Gal wrote that there’s no “magic bullet” to conclude it’ll definitively work. Still, Gal and his team believe it’s “very hard ... to see importation becoming a real pathway” to lowering prices, in part because pharma companies can “stop it operationally.”
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The lawsuit is only one of multiple challenges to—or setbacks for—the government's importation plan. Last week, Canadian officials said they’d restrict exports to the U.S. if they could “cause or worsen” a shortage.
Plus, Florida, which jumped at the chance to bring in less-expensive drugs from Canada, failed to find a private partner to help it set up a statewide program. That setback will delay the program for several months at least.
Approval pathway closed
Meanwhile, federal health officials are doing away with the FDA’s Unapproved Drugs Initiative, according to a posting in the Federal Register. The program allowed companies to secure formal clearance for old products that were on the market but predated modern approval requirements.
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Over the years, the program has been tied to price increases and shortages for products that were readily available at far lower cost before FDA action.
After the agency intervened, drugmakers that jumped through hoops to win an official nod scored market exclusivity that allowed them to set brand-name prices and quash any competition.