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Incoming ASCRS president calls for less restriction in discussion of off-label drug and device usage
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BOSTON — The U.S. Food and Drug Administration functions successfully in protecting public health, but the regulatory body's restrictions on off-label usage limits physician information sharing and, ultimately, affects patient care, according to the incoming president of the American Society of Cataract and Refractive Surgery.
 R. Doyle Stulting |
Addressing the ASCRS membership at the opening ceremony, R. Doyle Stulting, MD, PhD, said that the FDA's institutional structure and legislative mandate have obfuscated its primary intent.
"In its zeal to accomplish their primary task, the FDA has made the pathway to drug and device approval long, arduous and expensive. As a result, we often find ourselves years behind the rest of the world in providing new technologies to our patients," Dr. Stulting said.
For instance, Dr. Stulting said, the FDA is increasingly scrutinizing the sharing of information on non-approved usage, even though this information is often found in medical textbooks and in certification exams.
"I believe it is time to clarify that the label does not necessarily reflect all the appropriate uses of drugs and devices," he said.
"We need an FDA that actively facilitates the approval of new products when the balance of scientific evidence from all sources supports that action," Dr. Stulting said.
Dr. Stulting said that the ASCRS recently sent a letter of support to Allergan in its lawsuit challenging the government's ability to restrict information sharing on off-label use of Botox (botulinum toxin type A) on First Amendment grounds.
"In addition, ASCRS is working to find a way to remove the negative connotations of off-label use and allow us to freely discuss ways we can improve patient care," Dr. Stulting said.
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