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EW FEATURE 44 by Vanessa Caceres EyeWorld Contributing Writer just one company by using a brand name for one drug and not the others," she explained. CME events will likely increase due to the current educational restrictions, Dr. Schallhorn said. However, there must be a clear reason for the event. "An unmet need should be identified, and the speaker attempts to educate the at- tendees relative to the unmet need," Dr. Cionni said. After CME events, an attempt should be made to demonstrate that attendees benefit- ted from the education, he added. Another type of event is one that is neither CME nor held by a drug manufacturer, Ms. Shuren said. This would be a program held perhaps by a company that specializes in medical events, and the organization holding the event seeks corporate sponsors for it. This is a grayer area in terms of what can or cannot be said promotionally, Ms. Shuren said. others will permit a brief answer, with the caveat that the speaker is venturing into off-label uses, he said. On the other end of the educa- tional spectrum is the growing num- ber of continuing medical education (CME) events held by a variety of organizations. "The company gives a grant and gets recognized as a sponsor but has no say over the program," Ms. Shuren said. These events provide a more open forum and do allow for off-label discussion of medications. "The speaker still needs to an- nounce financial disclosures relative to the talk but can discuss off-label use as long as the speaker clearly states that the use is off-label," Dr. Cionni said. "This makes it easier to present how products are actually used by the ophthalmologist." However, these events must still aim to provide fair coverage, Ms. Shuren said. "For example, if you're using a brand name for a drug, you must use brand names all around. It can't seem as if you're promoting Corporate events subject to greater restrictions regarding off-label uses, discussions D rug manufacturers and the physicians who speak at their educational events are feeling the squeeze of off-label discussion restric- tions. The U.S. Food and Drug Ad- ministration (FDA) has made it clear that off-label uses are off the table at these events, which limits a portion of reasonable discussion for certain drugs, said Robert J. Cionni, MD, medical director, The Eye Institute of Utah, and adjunct clinical pro- fessor, John A. Moran Eye Center, University of Utah, Salt Lake City. "This often makes it difficult to explain how we really use a product, as it is very common to use a medication or device slightly differently than the exact use that it was approved for," he said. "A great example is the use of antibiotic be- fore, during, or after cataract surgery, as none of the antibiotics are labeled for use in preventing infection after cataract surgery, but every surgeon uses them off-label to do so." "A few years ago, we were able to discuss clinically relevant issues in a corporate-supported talk as long as it was fair and balanced and we didn't cross the line in being too corporate. There was freedom of speech," said Eric Donnenfeld, MD, clinical professor of ophthalmology, New York University Medical Center, New York. "It allowed ophthalmolo- gists to have interesting discussions around issues that might not be included in the FDA monograph. From my point of view, that's how education occurs." "The FDA's restrictions on bio- pharmaceutical companies' ability to share authoritative, regulated data about prescription medicines limits healthcare professionals' access to information that can help them make informed decisions based on their patients' individual healthcare needs and preferences," said Lauren K. Roth, assistant general counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C. The off-label discussion restric- tions extend to company materials, journal advertising, and other sales aids, Ms. Roth said. Because of this, PhRMA is asking the FDA to revise its regulations to allow companies to share truthful, scientifically accurate, and data- driven information with healthcare professionals to inform treatment decisions and get the best possible health outcome for patients. Although the goal may be to present fair and balanced education, Steven Schallhorn, MD, San Diego, believes the regulations do not give physicians enough credit for apply- ing their own critical thought to what is presented in an educational forum and deciding the best way to treat their patients. He also believes that off-label restrictions put too much of a squeeze on companies. "Companies are fearful of running afoul of the regulations, and justifiably so," he said. Educational forums The restrictions regarding off-label discussions of products vary ac- cording to the type of event, said Allison Shuren, JD, Arnold Porter, Washington, D.C. One scenario is the aforementioned event managed by a drug manufacturer or when a sales rep for such a company meets individually with physicians. "These [encounters] follow strict criteria and must be on-label discussions," Ms. Shuren said. If an audience member asks about an off-label use at such events, there is somewhat of a gray area regarding how to respond, said Dr. Donnenfeld, who speaks frequent- ly at corporate and non-corporate educational events. Some companies have instructed speakers to not answer any off-label questions, while The changing face of medical education December 2014 Sticking to the rules AT A GLANCE • FDA restrictions regarding what can be said about the off-label use of medications and devices affects physician education events. • Physician education events held by pharmaceutical manufacturers must stick to FDA-approved uses of products. • Continuing medical education events have more leeway regarding product discussion, although there must be a need for the education provided.