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Plavix Case: Deceptive Marketing or Regulatory Non-Compliance
(Thursday, February 18, 2021) In a stinging rebuke of their policy to withhold critical information about Plavix from FDA and the public, a judge in Hawaii fined BMS and Sanofi $834 million. Although the judge found the companies guilty of deceptive marketing, the ruling document describes a detailed timeline of information available to the company which could signal additional trouble from regulators and other agencies. Companies are required to report of any known or potentially serious issues with their drugs at any time they become aware of the same. From the timeline it appears that BMS and Sanofi were aware of the potential risk of their blockbuster drug around the time the drug was approved by the FDA in 1997. At the time of approval, the companies agreed to conduct post-market studies to evaluate the effect of race on the risk and benefit of the drug. But according to the court documents, the companies intentionally downplayed the risk and failed to fully investigate the risk. It wasn’t until 2010 (13 years after FDA approval) that FDA finally put a black-box warning on Plavix label warning of the risks to Asians and Pacific Islanders. By that time, the product has reaped billions of dollars in profits to the companies. What followed was a series of investigations, first by the Department of Justice, disclosed by the company to SEC in March 2013, followed by the Hawaii lawsuit in March 2014. Similar lawsuits are being pursued in New Mexico, and other jurisdictions may be looking to potentially join in or directly sue the companies. The case raises interesting questions about the responsibilities of a company about what it knows or suspects versus what it tells the regulators and public. The court concluded that the company was responsible for taking precautionary measures to warn the patients and doctors much before FDA told them to do so but that would have raised regulatory concerns for the company. A manufacturer is required to work with the FDA regarding any critical new information about its product and only after FDA agrees with the concern is the manufacturer expected to notify other stakeholders. The scientific information to address any theoretical concerns takes time to be generated and reviewed by the FDA, during which time the company is allowed by law to keep marketing its products as approved. So technically, BMS/Sanofi likely did not break the FDA laws. It is important to note that the outcome of the DOJ investigation from 2013 to find if BMS/Sanofi violated any of their regulatory responsibilities is not publicly known. Another notable absentee in this debate is the FDA. This indicates that likely DOJ and/or FDA did not find any evidence against the companies. This also explains why the court decided to take the “deceptive marketing” accusation over “regulatory non-compliance” as the primary offense. This is not over. BMS/Sanofi know the long-term consequences of this ruling and have vowed to appeal the same. But the details in the court document should serve as a case-study for all developers on their perceived and required responsibilities regarding new negative information for their products. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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