FDA Questions Need for Looser Off-Label Promotion Restrictions

FDA Questions Need for Looser Off-Label Promotion Restrictions

November 14, 2016, Regulatory Affairs Professionals Society

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Regulatory Affairs Professionals Society article regarding regulations on off-label promotions for drugs and devices. According to Labson, safe harbors are needed for communicating certain types of information outside a drug's approved labeling with healthcare professionals and payers. This information, Labson said, should include predefined categories of communications and types of evidence such as so-called real world evidence and data from clinical trials that was not used in the product's marketing application. 

Labson also said that companies should be able to share information with healthcare professionals about "medically accepted unapproved uses of FDA-approved medicines,” and that these professionals currently lack ready access to some of this information. "These groups require complete, current and reliable information about treatment options to inform coverage and prescribing decisions," he said, adding, "Biopharmaceutical manufacturers are uniquely situated to provide to these audiences robust and current information about the medicines they have researched and developed."