This week, officials at the United States Food and Drug Administration abandoned efforts to appeal a recent ruling that protected off-label promotional activities as part of free speech. This may stymie the federal watchdog agency’s ability to curtail improper drug and medical device marketing.

In December of 2012, a court in New York overturned a ruling by a lower court against Alfred Caronia, a Xyrem sales representative accused of illegal marketing practices. Caronia marketed Xyrem for off-label uses that weren’t approved by the FDA.

FDA guidelines prohibit manufacturers from making marketing claims until those claims are substantiated or approved by the FDA. For example, drugs and medical devices that have been approved for a certain use in overseas markets can not be marketed for that use in the United States until approved by the FDA.

In a 2-1 ruling, the New York Appellate court decided that Caronia could not be punished for his off-label marketing practices. The court ruled that punishment would be a violation of his free speech rights. In a statement, the court majority wrote, "The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug."

The FDA countered by stating that it "does not believe that the Caronia decision will significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act.”

References

www.massdevice.com/news/fda-abandons-label-marketing-protection-ruling?p...