Pricey weight loss drugs like Wegovy and Mounjaro have exploded in popularity, creating opportunities for counterfeit drug manufacturers and challenges for regulators and enforcers. In the final episode of Season 5, Keturah Taylor talks with Cozen O’Connor colleagues Danielle Sapega and Rick Van Buren about the state of federal and state regulation and enforcement and they outline a road map to help legitimate market participants avoid pitfalls.

(00:30) Host Keturah Taylor introduces herself, the topic for discussion and her two expert Cozen O’Connor guests, Danielle Sapega and Rick Van Buren.

(01:57) Danielle outlines the current state of FDA enforcement and regulation, including the impacts of the dramatic reduction in force that has taken place at the FDA which has resulted in missed deadlines and lack of responsiveness.

(3:18) She goes on to say that the impacts are being felt across the agency, and the true extent is still unfolding.

(4:01) Keturah explains that a trend in the state AG space is that when federal agencies dial back, state AGs will step in and fill perceived enforcement gaps.  She asks Rick to comment on state or federal legislative activity relating to GLP-1s and mandated insurance coverage.

(5:21) Rick points to both the effectiveness and the cost of GLP-1s as the key factors that state and federal legislation has been aimed at addressing. Some states have passed coverage mandates and Congress has introduced bills that would expand access whilst controlling costs, but the efforts have been pretty scattershot to date. Rick adds that both state and federal government agencies are going through a period of uncertainty at the moment around tariffs, tax reform and cuts to Medicaid which is hampering decisive action.

(9:22) Danielle explains that the rapid increase in demand for these drugs has caused shortages, which the FDA has stepped in to address, empowered by a special section of the Drug Quality and Security Act that allows compound pharmacies to meet need by mass producing drugs that mimic the name-brand drugs. However once a drug is removed from the shortage roster, compounding pharmacies are required to stop manufacturing it, which they haven’t always done. These bad actors are typically based overseas so beyond the reach of the FDA or other federal agencies.

(13:24) Keturah comments that state AGs are basically borrowing the same playbook as is used by the federal agencies to crack down on such illicit or counterfeit products. Ohio AG Tong has been amongst the most active. She asks Danielle or Rick for their perspectives on the implications for legitimate companies facing competition from counterfeit or dangerous products.

(15:10) Danielle stresses that companies need to make sure they’re operating within the law, that their policies are up to date, and that they are preparing for the possibility of an inspection by a federal or state agency by conducting mock exercises.

(16:01) Rick added that the problem of bad actor tainting an industry’s reputation is not limited to drugs and that legitimate businesses need to differentiate themselves through engagement and education and outreach in order to avoid being caught in the blast radius of an investigation.

(17:16) Keturah asks Rick if companies should choose to prioritize their engagement at the state or federal level, but he stresses that it need to be at both levels. She outlines some potential issues on which companies may want to engage with state AGs.

(20:18) In closing, Danielle makes the point that state boards of pharmacy have oversight over pharmacies in their state and are very much invested in making sure that the medications being produced are safe and effective and not contaminated, so they may be an additional source of enforcement activity.

(21:12) Keturah concurs and notes that the relationship between state AGs and pharmacy boards varies a lot from state to state.

(22:16) Rick makes the point that the tension between access, cost, state federal legislation and the downstream effects of bad actors and market incentives are not unique to GLP-1s and apply not only more broadly to the drug industry, but to other industries as well.

To listen to the full podcast, click here. To listen to a particular section, open the recording and use the time stamps provided above to navigate to the desired part.