Given the popularity of weight loss drugs and the shortages that have resulted, many compound pharmacies have helped to fill the drug void with compounding to ensure that the drug is commercially available for patients. However, manufacturers of the FDA-approved products have been very active with lawsuits and litigation. Eli Lilly, for example, has served subpoenas on non-party compounding pharmacies for documents regarding the pharmacies’ compounds and processes.
What is a subpoena and what does it require of you?
A subpoena is a legal document that allows a party to a lawsuit to request sworn testimony or documents. It is a litigation tool that gives a party the opportunity to obtain information and records from an entity that is not a party to a lawsuit. A subpoena carries the authority of the Court even though it may be issued by an attorney for a party. Since it carries the authority of the Court, it is important to take the subpoena seriously and adequately and timely respond to the request therein.
What should you do if you receive a subpoena?
Regardless of whether the subpoena calls for an appearance to testify or for records, the recipient should forward the subpoena to in-house counsel or speak to an attorney to help adequately respond. Failure to timely respond or failure to respond at all could result in a waiver of rights, contempt, or some other form of sanction by the Court. After discussing the subpoena with counsel, the response could be compliance with the request, service of objections, a combination of both, or even a motion filed with the Court seeking to quash the subpoena.
What should you do about compounding drugs on the FDA shortage list?
At minimum, compounders must be in compliance with state Board of Pharmacy rules, United States Pharmacopeia Standards, as well as Section 503(A) of the Food Drug and Cosmetic Act, which includes, among other things, compounding based on valid, medically necessary patient specific prescriptions, and use of approved Active Pharmaceutical Ingredients (API). Best practices include vetting API manufacturers and conducting third-party testing.
Overall, the enforcement landscape has changed. Pharmacies not only need to ensure compliance with regulatory standards, but must also take into account the complexities of patent, consumer protection, and other state specific laws. Improperly handled subpoenas could lead to legal battles, financial losses, and reputational damage for pharmacies that are unprepared to defend their practices. It’s crucial for pharmacies to seek legal advice and representation to navigate these challenges successfully.
How Frier Levitt Can Help
Our firm has been at the forefront of legal issues affecting the pharmaceutical and healthcare industries, offering strategic advice and robust defense to our clients. We provide clear, comprehensive analysis of the legal challenges pharmacies face, including responses to subpoenas. Our team can help ensure your compounding and dispensing practices meet all regulatory and legal standards, minimizing the risk of legal action.
If your pharmacy has been affected by these recent developments or you’re concerned about potential legal risks, contact Frier Levitt today. Our team is here to provide the guidance and support you need to navigate these complex issues confidently. Together, we can ensure that your pharmacy remains a trusted and compliant provider of vital healthcare services.
