Spencer Fane attorneys Beth Siemer and Brian Malkin’s article, FDA and Novo Nordisk Warned of GLP-1 Telehealth Compounding Takedown. What’s Next? was recently published by Pharmacy Times.
In the article, which was originally a firm blog post, the team examines increasing regulatory and legal scrutiny surrounding the production and marketing of compounded GLP-1 weight-loss drugs. They outline how recent enforcement actions signal a shift toward stricter oversight of telehealth providers and compounding pharmacies and what these developments may mean for the future of the industry and its compliance strategies.
“Reading the writing on the wall and what it may signify, telemarketing companies, pharmacies, and other stakeholders selling GLP-1 products that are not FDA approved should consider this change in tone and action from both FDA and manufacturers in planning for the future, including in preparing to defend ongoing GLP-1 compounding or potentially realigning their compounding capacity for future markets,” the team wrote.
At the firm, Beth advises individuals and organizations navigating complex state and federal laws that govern transactions, compliance, and reimbursement. Working with various providers, payers, benefit managers, and vendors in the health care space, she offers practical tools, actionable advice, and customized solutions that allow her clients to keep the focus on innovating and providing high-quality products and services.
Brian streamlines processes for clients navigating the complex intersection of patent law and food and drug law, leveraging unique public and private sector experience, in-depth creative and strategic analysis, and advanced negotiation tactics to meet and exceed stakeholder expectations.
Read the team’s full article here.