Baker Hostetler Advisor
Baker Hostetler’s Lee H. Rosebush has deployed his varied expertise as a pharmacist, regulator and lawyer to steer drug makers through complex deals, billing investigations and new manufacturing programs, placing him among Law360’s top life sciences attorneys under 40. Rosebush, 34, arrives on the Rising Stars list with the sort of wide ranging resume that even grizzled veterans would be hard-pressed to match.
The highlights include roles as a hospital and retail pharmacist, an Eli Lilly & Co. regulatory division member, and a U.S. Food and Drug Administration reviewer of orphan drug designation requests. Now a partner at Baker Hostetler, Rosebush assists clients with transactions, reimbursement and quality control by tapping the lessons of his diverse vocations all across the pharmaceutical world.
“That has really given me the practical know-how,” Rosebush said. On the deals side, one of Rosebush’s more notable projects played out last year in the representation of Canada-based Cangene Corp. in its $300 million takeover of Maryland-based Emergent Bio Solutions Inc. Rosebush interacted with the FDA and its north-of-theborder counterpart, Health Canada, as part of due diligence on approvals, compliance and reimbursement — a potpourri of issues that Rosebush’s broad background helped him tackle. “Having the pharmacy reimbursement side, and having the FDA side, again set me apart,” he said. In the realm of billing investigations, Rosebush is representing a drug maker at the Office of Inspector General for the U.S. Department of Health and Human Services as part of thecompany’s self-disclosure of potential issues with its reporting of so-called average sales prices — something that was central to a recent $12.6 million settlement involving Sandoz Inc. Lee Rosebush ASPs have not traditionally resulted in a great deal of enforcement, but Rosebush said that it’s believed that there are a modest number of investigations currently under way.
“I don’t think we’re alone, but I would tell you it’s less than 10,” he said. On another front, Rosebush has emerged as something of a guru among lawyers specializing in compounding pharmacy laws and regulations, which have been overhauled significantly in recent years after a Massachusetts compounder sold contaminated drugs that killed dozens of Americans. His work includes guiding one of the first registrations of a compounder as a so-called outsourcing facility subject to FDA regulation under Section 503B of the Drug Quality and Security Act of 2013.
One issue to watch, Rosebush said, is whether more compounders follow suit, given the looming implementation of policies that may restrict shipments across state lines by unregistered mail-order pharmacies. “Several compounders have started to warm up to the fact that there is a potentially lucrative business model under 503B,” Rosebush said. “I think you’ll start to see an increase.” The overarching theme of all that work, Rosebush said, is his ability to lean on his three professional roles — regulator, pharmacist and attorney — to see all the perspectives then distill them into coherent messages that all parties to a matter can comprehend and resolve.
“My counseling to clients is really grounded in practical life experiences,” he said.