The God Particle, a trader on the social media platform X, said that legal precedent and federal law do not permit companies to sue compounding pharmacies over practices allowed under Section 503A of the Food, Drug, and Cosmetic Act. This statement was made on X.
"NVO is well aware they can't sue $HIMS," said God Particle. "There is decades of legal precedent allowing the compounding of medications under the 503A exemption under the FDCA. The FDCA (federal law) provides no (legal) private right of action for any citizen or company to sue for deemed violations. Last year, Eli Lilly tried using state courts to enforce the FDCA (again, they can't)"
Recent legal and regulatory challenges in the United States have highlighted the significant role of compounding pharmacies. According to the Wall Street Journal, these pharmacies provide personalized and accessible treatments when branded medications are either limited or unaffordable. As demand for alternatives to costly or scarce brand-name drugs increases, major pharmaceutical companies such as Eli Lilly and Novo Nordisk have initiated lawsuits aimed at restricting compounding. These companies argue about regulatory boundaries; however, many patients and advocates view compounding as essential for ensuring patient access and affordable care. The debate underscores tensions between protecting industry profits and upholding the public’s right to medication choices, prompting calls for regulatory clarity that supports the critical work of compounding pharmacies.
The U.S. Food and Drug Administration (FDA) reports that Section 503A of the Food, Drug, and Cosmetic Act permits traditional compounding pharmacies to prepare customized medications for individual patients based on specific prescriptions. Meanwhile, Section 503B creates a separate category for "outsourcing facilities" that can compound sterile drugs in bulk without prescriptions but must adhere to stricter federal quality standards. This regulatory framework aims to balance safety with patient access to personalized and affordable medicines.
Last year, a federal court ruling reported that Eli Lilly attempted to use state law to enforce terms of the Federal Food, Drug, and Cosmetic Act (FDCA), a role typically reserved for the FDA. However, the judge rejected this approach, stating courts have "nearly exclusive" federal authority over FDCA enforcement. Allowing state law as a back door for private enforcement would overstep legal boundaries; this decision reflects ongoing judicial resistance to private parties litigating federal regulatory compliance in state courts.
According to a recent post on X, compounding pharmacies like Empower Pharmacy have faced significant legal challenges. Dr. Shaun Noorian is reportedly "standing up to giant $LLY," while leaders such as Andrew Dudum are also joining the effort. This reflects growing social media support for "wartime CEOs" defending patient access to affordable medications against major pharmaceutical companies amid legal pressure.
Eli Lilly, an American pharmaceutical company established in 1876, has repeatedly faced criticism for its role in increasing the cost of essential medications like insulin. This has led to lawsuits, political hearings, and public outrage over its pricing practices and efforts to restrict affordable compounded alternatives for patients in need.
Alerts Sign-up