US Food and Drug Administration wants to track promotional spending to spot off-label marketing
The US Food and Drug Administration (FDA) is offering a contract for a company to collect and analyse data on pharma companies’ promotional activities. The aim is to use this big data approach to spot off-label marketing and other forms of marketing fraud.
The purpose of the contract, which will see the successful provider working with the FDA’s Office of Criminal Investigations, is to provide real-time access to current and historical data on how pharma companies are spending their marketing cash, as well as how FDA-approved drugs are being prescribed, distributed, advertised and promoted.
Off-label marketing, where companies promote a drug for a disease for which it is not specifically approved, is a significant problem. US doctors are allowed to prescribe drugs for alternative conditions, and can ask companies to provide data about off-label applications, such as research papers. But the companies cannot actively promote drugs for conditions without regulatory approval.
Two recent high-profile cases have shown the scale of the problem and how companies can find themselves on the wrong side of the law. In 2012, GlaxoSmithKline was handed a record fine of $3 billion (£1.9 billion), and Pfizer was fined $2.3 billion for off-label marketing activities in 2009.