On today’s sponsored episode of Legal Drugs Podcast, Host Angela Stoyanovitch, speaks with Lee Rosebush, Partner at Baker & Hostetler, LLP. Lee is one of the scheduled speakers at the upcoming compounding pharmacy live stream salon hosted by PharmaSalon. To learn more about the Aug. 18-20th, 2020 event and to register, go to www.pharmasalon.com.
Lee Rosebush is the Pharmacy & Reimbursement Team Leader and Co-Leader of the FDA Practice at Baker & Hostetler. With a unique background as a defense, regulatory, and registered patent attorney who has also worked as a pharmacist, Lee provides his clients with legal counsel that is grounded in first-hand experience. He possesses a unique understanding of the pharmaceutical industry (legal drugs business as we like to say) which, combined with his attention to detail and experience with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel. He is a star when it comes to navigating legal, governmental, and pharmaceutical environments, which helps him to more easily reduce the time needed to secure operating licenses or assist drug manufacturers to avoid compliance actions from governmental agencies. For more on Lee, go to; https://www.bakerlaw.com/LeeHRosebush.
In this episode, Lee and Angela discuss some of the issues arising around outsourcing drug manufacturing abroad (where standards are different) and how the pandemic has exasperated these problems in the legal drug manufacturing business.
The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities who focus on providing patients and healthcare providers with safe and effective compounded medications. To learn more about the Outcoursing Facilities Association to go www.503bs.org.
*As referenced on the episode, here is the link to Lee's article, Outsourcing U.S. Drug Manufacturing to China was a Mistake - A Lethal One [Opinion]; https://www.newsweek.com/pharmaceutical-manufacturing-america-china-lethal-mistake-1502008.
This episode edited and produced by Margaret Beveridge.