Sunshine Act Data Could Increase FDA’s Ability to Prosecute Marketing Violations

June 14, 2013 – The data collected under the Physician Payments Sunshine Act will be part of a database that the FDA’s Office of Criminal Investigations (OCI) is building to detect potentially fraudulent activity, including off-label marketing violations, according to a June 11 article in Policy and Medicine.

The OCI “recently issued a solicitation notice on the Federal Business Opportunities (FBO) website indicating that the agency is looking for an outside party to put together a prescription drug and marketing database,” the Policy and Medicine article states.

The FDA “stated that the objectives of the proposed contract are to access data representing sales and expenditures by pharmaceutical companies on promotional and advertising strategies at a national level in the United States,” the article continues, adding that an important part of the OCI’s mission “is to “protect the public health by assuring that pharmaceutical companies are not off-label marketing their prescription drugs and that the information they provide to the public through their marketing is truthful and accurately communicated.” To read the full article, go to: