Off-Label Drug Use and Online Pharmacies Among Topics at Food and Drug Law Program
Web Editor - Published: March 25, 2013
“Our primary mission is to protect and promote the public health,” said Karyn M. Campbell, director of the Food & Drug Administration investigation branch for the Philadelphia district of the FDA’s mission as she spoke at the continuing legal education event hosted by the student-run Food and Drug Law Association.

Campbell joined Albert S. Glenn, an assistant U.S. attorney for the Eastern District of Pennsylvania, and adjunct professor of food and drug law Roseann Termini as featured speakers for the event.

Professor Termini spoke briefly about the importance of ethics in the practice of food and drug law to open the program before turning the podium over to Glenn, who shared his expertise on criminal prosecutions related to drugs – from illegal street drugs such as heroin or cocaine which he said “are not regulated in the sense that they’re not permitted to be used for the most part” to prescription drugs that have medicinal value but are controlled because they are addictive and have the potential for abuse.

“This is current. These are current problems,” he said of prescription painkiller abuse involving drugs such as oxycodone and hydrocodone before addressing the ways in which prescription pain pills make it onto the market, including doctors who prescribe the medicine without due diligence and pharmacies with lax inventory control.

Mr. Glenn also spoke about the problems with Internet pharmacies, noting that there are two primary types that federal authorities see regularly. The first involves pharmacies that take patient information and then forward it to doctors who then write prescriptions. The second bypasses any attempts at legitimacy and instead imports pills from foreign countries for distribution, provoking U.S. Attorneys to prosecute them for smuggling charges under customs enforcement provisions as well as illegal drug distribution.

“It is illegal for anyone to distribute controlled substances without a legitimate prescription,” he stated of the reason that Internet pharmacies fulfilling prescriptions based on an order from a doctor who never saw a patient are subject to prosecution. When asked why such pharmacies even bothered with the charade, Glenn replied, “They did it to appear legitimate.”

Glenn concluded his remarks by talking about off-label drug use. Manufacturers are prohibited from marketing drugs for off-label use because the FDA has not approved the drugs for those uses.

Campbell spoke last. She discussed the responsibilities of the FDA’s investigation branch in enforcing the Federal Food, Drug, and Cosmetics Act. She also spoke specifically about her office’s jurisdiction, which covers the cities of Philadelphia, PA; Wilmington, Delaware; and Camden, New Jersey. She concluded her remarks by sharing some anecdotes about investigations she has been involved with, including closing down a business that made sandwiches for vending machines while she was just beginning her career.