EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/422211
The role of corporate education With the tougher restrictions, what role remains for educational events—the corporate events—given by drug manufacturers throughout medicine? "It is still very helpful when a company launches a new product to educate physicians about their new product even if it must be on-label," Dr. Cionni said. "This is still one of the best ways for physicians to learn about new devices and medications." "When you have something new that comes out, it's important to hear about the FDA studies, the adverse events, and the clinical findings. The FDA trials are usually very well done, and there is inter- esting information in that," Dr. Donnenfeld said. Those areas are important to hear about in a corpo- rate event for a new drug, he said. Promotional educational events enable physicians to expand their ESCRS FREE 3 YEAR MEMBERSHIP FOR TRAINEES visit www.escrs.org today Become an ESCRS Member Integral to your continuing education FREE TO MEMBERS: Reduced ESCRS Congress Fees ESCRS iLearn Online interactive courses ESCRS On Demand Online library of presentations from ESCRS Congresses Subscription to Journal of Cataract & Refractive Surgery clinical knowledge, learn about side effects, learn about new medicines, and discover the range of treatment options and drug risks, Ms. Roth said. "These programs are especially important to physicians in rural communities, where peer interac- tions and access to professional con- ferences may be limited," she said. Ms. Shuren thinks that cor- porate breakfasts or promotional events to discuss new products will continue, but she added that local level speakers' programs seem to be decreasing because of the restrictions on what can be discussed. EW Contact information Cionni: rcionni@theeyeinstitute.com Desjardins: Philip.Desjardins@aporter.com Donnenfeld: ericdonnenfeld@gmail.com Roth: newsroom@phrma.org Schallhorn: scschallhorn@yahoo.com Shuren: Allison.Shuren@aporter.com Companies, physicians face fines for off-label discussions in certain forums T he U.S. Office of the Inspector General, the U.S. Department of Justice, and the FDA all aggressively enforce the Food, Drug and Cosmetic Act (FDCA), which has strict criminal liability for a company or individual violating the law and any related off-label restrictions, Ms. Roth said. "A company can be convicted of, or plead guilty to, a misdemeanor violation of the FDCA even if the company did not have an intent to violate the law," she said. Aggressive investigations have made companies wary of proactively sharing information about their medicines beyond that contained in drug package inserts, she added. Under the FDCA, a company must specify each intended use of a biological product, according to information from the FDA website. Any promotion by the manufacturer for off-label uses can render the product misbranded, the information stated. For the most part, the federal government targets companies as opposed to the physician speaker if inappropriate off-label product discussions occur at corporate education events, Ms. Shuren said. "Yet the physicians can get caught up as witnesses," she said. In a case called the United States v. Caronia, a federal Court of Appeals panel decided in December 2012 that promotion of a drug for off-label purposes is protected free speech under the First Amendment. The case involved a sales representative for a company called Orphan Medical, which manufactured the drug Xyrem (sodium oxybate). The drug was approved for narcolepsy and cataplexy. The sales rep was accused of promoting Xyrem to physicians for other uses, such as insomnia, fibromyalgia, restless legs syndrome, and other conditions. However, the ruling in this case has not yet caused a huge shift in off-label discussions, said Phil Desjardins, JD, Arnold Porter. EW