U.S. judge throws out lawsuit to stop states from importing drugs from Canada

A U.S. federal judge has thrown out a lawsuit that tried to stop states from importing medicines from Canada. U.S. District Court Judge Timothy Kelly said in the opinion that drug companies had failed to prove that a federal rule allowing states to import medicines would create a “concrete risk of harm” for them. Instead, he said, any harm is speculative because the federal government could not approve state proposals—so the industry didn’t have the standing to file a suit. The plaintiffs in the suit—Pharmaceutical Research and Manufacturers of America (PhRMA), Partnership for Safe Medicines and the Council for Affordable Health Coverage—had argued that importing medicine from Canada is dangerous, unlikely to reduce the costs Americans pay for drugs and that they would place a burden on drug companies. It also said increased competition might make them lose exclusive marketing rights and lower the value of patents. And it argued that if an imported medication were unsafe, that would reduce goodwill towards the industry and increase other costs. Read: U.S. FTC asks judge to hold ‘Pharma Bro’ Martin Shkreli in contempt of court That ruling ought to please U.S. President Joe Biden's administration, which asked the federal court judge to dismiss the lawsuit, calling it was premature. The decision “will make it hard for the administration to not move ahead (on state proposals). And that’s a good thing,” Jane Horvath, a former healthcare policy strategist at Merck and consultant who has worked with the National Academy for State Health Policy, told STAT News. She also said she believed that the PhRMA would do so again once the first state is approved. Indeed, PhRMA expressed disapointment in the ruling. “In the final rule, the administration punted the responsibility for demonstrating safety and cost savings to state governments. This is despite the clear requirement under federal law that the U.S. Health and Human Services Secretary must certify that imported drugs both pose no additional risk to public safety and will lead to significant savings for the American consumer. The rule needlessly puts the health and safety of Americans in jeopardy,” a spokesperson for PhRMA said. Read: Amid U.S. Ozempic shortages, users turn to Canadian pharmacies Peter Pitts, a former associate commissioner of the U.S. Food and Drug Administration, who heads the Center for Medicine in the Public Interest, a think tank funded partly by the pharmaceutical industry, also told STAT he thought it was a bad idea. “There is a difference between ‘legal’ and ‘a good idea,” he said. “Per numerous Congressional Budget Office reports, it will not save consumers any money and, per FDA, it will compromise pharmaceutical quality. Drug importation is a worst kind of political soundbite. As H.L. Mencken said, ‘For every complex problem, there’s a solution that is simple, neat, and wrong.’ This is drug importation in a nutshell.” Gabriel Levitt, who co-founded PharmacyChecker.com and is an unpaid advisor to the state of Colorado, told STAT that tens of millions of Americans were already importing prescription drugs from Canada and that this legislation would allow them to occur under the guidance of the FDA. “The industry trade group has . . . vigorously opposed prescription drug importation for decades, often using scare tactics about safety that have no basis in reality.” Several states have explored importing drugs from Canada as a potential solution to high numbers of people having trouble paying for their medications in the U.S. Florida, New Mexico and Colorado have already submitted proposals to the federal government asking for permission to import medicine, and Maine and Vermont have also released draft proposals. Read: Abortion tourism a concern in Canada, but out of reach for most Americans: advocates

U.S. judge throws out lawsuit to stop states from importing drugs from Canada

Register for free access or login.

Related Topics