Pharmaceutical Manufacturers Under Scrutiny for Potential State Law Violations Regarding Puberty-Blocking Medications - JD Supra
Texas Attorney General Ken Paxton recently served identical civil investigative demands (CIDs) to two pharmaceutical manufacturers connected to allegations that they advertised and promoted unapproved uses of puberty-blocking medications without disclosing potential risks to children and their parents. While AbbVie, Inc. and Endo Pharmaceuticals, Inc. are currently the subject of this investigation, this development may be representative of a larger and renewed focus by state AGs on the pharmaceutical industry.
The CIDs come on the heels of an investigation into Abbvie and Endo, announced by Paxton in December 2021. The products at issue are two puberty-blocking medications, Supprelin LA and Lupron Depot, both FDA-approved to treat children with central precocious puberty in which puberty commences prematurely. Some forms of Lupron also have been prescribed for palliative treatment of prostate cancer.
The Texas AG’s investigation is led by the Office’s Consumer Protection Division and is founded upon alleged deceptive and false advertising in violation of the Texas Deceptive Trade Practice Act (DTPA), which provides that “false, misleading, or deceptive acts or practices in the conduct of any trade or commerce are…unlawful.”
Based on the information requested from Abbvie and Endo in the CIDs and Texas’ press release, these medications appear to be under scrutiny because they now are being used off-label to treat gender dysphoria without FDA approved for such use. Consistent with the DTPA’s focus on whether the companys’ representations directly to consumers, or by and through health care providers, are false, misleading, or deceptive, the CIDs seek information related to marketing, advertising, and promotional materials on the usage and the disclosure of potential side effects of these products.
Takeaway
The investigation and subsequent CIDs underscore the renewed focus of state AGs toward combatting perceived deceptive, false, and misleading advertising of pharmaceuticals. Additionally, the ever-shifting political landscape may leave some pharmaceutical companies vulnerable to increased scrutiny regarding the promotion and use of their products. Accordingly, it is vital that pharmaceutical companies institute compliance mechanisms to manage and coordinate responsive efforts in the face of regulatory scrutiny.
Troutman Pepper has considerable expertise and knowledge in the pharmaceutical regulatory compliance space and has developed a working process to address and resolve government investigations into its pharmaceutical clients. Troutman Pepper consistently monitors this space for developments and stands ready to advise clients in this rapidly evolving landscape.
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source: https://www.jdsupra.com/legalnews/pharmaceutical-manufacturers-under-4793609/
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