Regulatory Focus™ > News Articles > FDA Looks to Big Data to Assist Off-Label Marketing Investigations

FDA Looks to Big Data to Assist Off-Label Marketing Investigations

Posted 31 May 2013 | By Alexander Gaffney, RAC

The US pharmaceutical industry has long been known to aggressively market its products, and not always in a scrupulous fashion. Now a new notice posted on the Federal Business Opportunities (FBO) website indicates that federal regulators with the US Food and Drug Administration (FDA) are preparing to buttress their investigations using real-time, big data approaches previously only used for postmarketing safety assessments.

The solicitation, which was first posted on the FBO website on 22 May 2013 and recently updated, calls on the private sector to assist FDA's Office of Criminal Investigations (OCI). The office is, as its name implies, FDA's enforcement arm, and works with the Department of Justice (DOJ) and other federal agencies to go after companies it believes are breaking the law, and most often the Federal Food, Drug and Cosmetic Act (FD&C Act).

In recent years, the aspect of the FD&C Act that most companies seem to violate is its prohibition against off-label marketing. In such instances, drugs that have lawfully obtained approval for a given indication from FDA will be explicitly marketed by the company for another indication. The activity skirts a fine legal line in which doctors may prescribe a drug off-label and may ask a company about off-label data that they may have, but the companies may not themselves push this information.

And that raises a question: How can federal regulators stay abreast of interactions between doctors and marketers that typically only occur behind closed doors?

Finding Fraud Using Lots and Lots of Data

That's where OCI comes into play. In 2010, the office created the Pharmaceutical Fraud Program (PFP), a sub-office dedicated to investigating pharmaceutical-based fraud. The office is supported with funding from the Centers for Medicare and Medicaid Services (CMS)-an office which has been eager to cut down on the practice of off-label marketing, which inflates what it spends through Medicare Part D and Medicaid programs.

And now, under the guise of the PFP, the OCI is gearing up to go after off-label prescription drug marketing to make sure companies at in compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act).

But how should OCI do this? For starters, it says it needs "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."

In other words, FDA is once again looking to big data to solve big problems. As FDA explains later on in the solicitation, "The data will be real-time, immediate, direct, multi-user, with desktop access to currently existing, commercially available, to current and historical data"-a dream to any investigator who wants to see which products are being prescribed off-label.

FDA said it wants the system to include a sample of products, professional journals, consumer journals, physician specialties, manufacturers, advertising media, hospital pharmacies, and regions. In addition, the system will need to track promotional spending, contacts between industry and physicians, and other data intended to assess the scope of interactions between various entities.

Data should go back in time at least six years, FDA noted.

For now, FDA's still looking for a partner for the activity, which it says will span four years if all goes well. Solicitations will be accepted until 7 June 2013, and a final contract is slated to be awarded on 1 July 2013.

FBO Solicitation Notice

Tags: OCI

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