FDA gets tougher on the Pharma industry via DDMAC
The hiring of 12 new reviewers for the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is allowing the agency to beef up its scrutiny of Pharma promotional materials. There has been a marked increase in the number of warning and untitled letters sent to manufacturers in the past few months.
The FDA said it has a greater capacity to review promotional pieces because of staffing increases, but the agency did not say a recent spate of regulatory letters was a direct result of taking on new staff.
This move will be especially interesting for oncology, where there is significant off-label prescribing of cancer drugs by physicians based on published peer reviewed journal data. Under the original Washington Legal Foundation FDAMA guidelines, pharma companies could give out journals describing off-label data if the physician asked for information.
However, many pharmaceutical companies have taken a more cautious, conservative approach in this area over the last few years as FDA became more aggressive scrutinizing materials, promotional or educational.
The source of this news is Drug Industry Daily.