The FDA wants to infuse more data analytics into the agency's hunt for unlawful activity in the pharma industry. The regulator has put out a call for external experts to provide its investigators with access to real-time data on pharma product distribution and promotions, Regulatory Focus reports, speculating that the technology could be used to identify cases of off-label marketing of drugs.
Federal investigators have made huge headlines with their efforts to nail drugmakers for marketing drugs for unapproved uses--a major no-no that subjects pharma groups to massive fines. Pharma giants have agreed to billions of dollars in fines to the U.S. government for such off-label marketing practices, which were part of the landmark $3 billion penalty for GlaxoSmithKline ($GSK) last year related to dubious promotions of antidepressants. Authorities also hit Johnson & Johnson ($JNJ) with $181 million in penalties in connection with off-label marketing of the antipsychotic drug Risperdal.
Now that many pharma marketing practices have gone digital, FDA investigators want the tech tools to monitor pharma activities on their desktop computers. As RF reported, the agency's request for tech support includes "timely access to current and historical data for analysis and forecasting of trends relating to FDA approved pharmaceuticals and biologics based upon their distribution, prescribed usage and advertising and promotional expenditures." Also: "The data will be real-time, immediate, direct, multi-user, with desktop access to currently existing, commercially available, to current and historical data."
The FDA wants the investigators' system to track a variety of data, too. Count in data from journals, consumer publications, manufacturers, advertisements, pharmacy records, promotional spending, drug info and records on industry-physician contacts. The agency wants it all at the fingertips of its criminal investigation unit, going back at least 6 years, RF reported. The solicitation went out last month with plans to award a contract by July 1.
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