FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease industry, but attorneys say implementation may face challenges for spurring rare drug development. “It’s a wait-and-see in terms of which mechanism FDA might use and whether they will need a legislative vehicle or not to implement something here,” said Julie Tibbets, chair of Goodwin's life science regulatory and compliance practice. While legislation would likely take the longest, it would be the “cleanest” vehicle to bring a pathway forward and establish a clear and strong framework, Tibbets said. “A lot of folks think that the most difficult part of getting to the market is FDA approval, and that’s a huge hurdle, but it’s equally as challenging when there’s insufficient coverage or lack of coding or no payment,” said Matthew Wetzel, a partner at Goodwin. “All those benefits aren’t going to really mean much if they are stuck with that limitation under the IRA.” Read the Bloomberg Law article for more.