The FDA extends deadline for off-label input
The FDA extended a comment period gathering input about off-label communications by 90 days.
The regulator held a two-day public hearing in November on the issue and had originally called for input from drugmakers in September. The new comment period now ends April 10, 2017. The previous deadline was January 9.
The hearing in November raised a number of questions about what FDA-sanctioned off-label communications would look like. Experts at the hearing discussed whether sharing off-label communications would lessen the incentive to conduct costly well-controlled studies; at what point information about a product becomes medical evidence; and if physicians have the time to discern what information shared by drugmakers is potentially misleading, among others.
Earlier this week President Obama signed the 21st Century Cures Act into law, which will force the agency to draft guidance within two years on the use of real-world evidence in supplementary indications of already approved drugs and clarify the scope of information drugmakers can share with payers.