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On-label and off-label discussions
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My residents were surprised when I explained to them that there are two distinct kinds of physician meetings and that the content of each is markedly different.
Industry-sponsored promotional discussions
In these programs, such as local dinner talks where a speaker talks specifically about a pharmaceutical or surgical product, the content is strictly limited. Because an ophthalmic company is sponsoring the event, the slides and the content of the talk must be strictly limited to on-label discussions. The company will directly choose and sponsor the speakers and will train them to deliver its message consistently and accurately.
On-label means that anything that is discussed has an FDA-approved indication. For example, if the label indication for an NSAID is “for the treatment of inflammation and pain for 2 weeks after cataract surgery,” then only that specific indication must be promoted. A discussion about using this drug for longer than 2 weeks is not allowed. Neither is the use of the drug for other surgeries or to help treat cystoid macular edema. If an audience member asks an off-label question, it must be identified as such, then briefly addressed, and then the discussion should be brought back to on-label. To prevent corporate liability, all slides, materials and handouts must be cleared by the company’s legal department. So far, billions of dollars of fines have been paid by pharma and device companies, and hundreds of millions of those were ophthalmology-related corporations.
Continuing medical education (CME) discussions
These programs are designed to provide physicians with CME credits, and they are organized by a third party, sometimes affiliated with a university and sometimes through the medical education arm of an ophthalmic journal or publication. The ophthalmic companies can help to sponsor these meetings but only via unrestricted educational grants. This means that the ophthalmic company cannot choose the speakers or the content of the program.
The speakers in these CME programs develop their own fair-and-balanced presentations and slide decks with a goal of teaching clinically relevant pearls that will aid in patient care. These slides must be evaluated by an independent reviewer to check for balance, accuracy and lack of bias. In these programs, the speaker may talk about using drugs or devices in an off-label manner. And many of the things that we routinely do in everyday practice are, in fact, off-label. Using an antibiotic perioperatively is off-label, as is suturing an IOL to the iris, or even using a drug for a week longer than its label states.
Finally, there is one more type of physician meeting where there is more freedom: private physician-only meetings. If I gather a bunch of my ophthalmology colleagues and we pay for our own dinners, then we are free to discuss what we wish about any product, even if it is very much off-label. And quite often, these are the most fruitful of all meetings.