The DOJ Sets Its Sights On Forest Laboratories

February 27, 2009 by Justin Goldstein · 2 Comments
Filed under: Drugs & Medical Devices, FDA 

Via neur0nz at Flickr

Photo by neur0nz via Flickr

Forbes reports in its article, “Forest says 11 states will join fraud lawsuit,” and the New York Times reports in its article, “Drug Maker Is Accused of Fraud,” that a civil claim was filed against Forest Laboratories Inc. under the False Claims Act. The claim relates to the advertisement of the  “off-label” use of certain drugs.

Forbes reports:

The Justice Department said Forest promoted Lexapro and Celexa for use by children even though it is not allowed to do so. While doctors are allowed to prescribe drugs for uses not listed on the labels, companies are not allowed to actively promote the drugs for that kind of “off-label” use.

This suit is similar to the qui tam actions against Scios.  Both the cases against Scios and the suits against Forest Laboratories involve the off-label marketing of the unapproved uses of certain prescription drugs.  And like the claims against Scios, it appears that the case against Forrest Laboratories began as a qui tam action.

The NY Times reports:

The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.

This case is consistent with the DOJ’s heightened investigation of the pharmaceutical industry and shows the federal government’s reliance on qui tam actions.  As the number of cases against pharmaceutical companies for the off-label advertising of the unapproved uses of drugs increases, the gap between the FDA approval of the use of drugs and the actions of pharmaceutical companies is becoming more apparent.

To some extent, the Civil False Claims Act is bridging this compliance gap by functioning as a mechanism to enforce FDA decisions on the uses of drugs. But perhaps a legitimate question to ask is whether this increasing reliance upon an “outsourcing” of regulatory compliance is the appropriate mechanism by which to fix this inefficiency. Or, might we consider, as recommended by the recent Center for Health & Pharmaceutical Law & Policy whitepaper, being that “estimates suggest that as many as 40% of all prescriptions are for off-label uses,” that we give the “FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety?”

As the Center stated, “this would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.”

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2 Responses to “The DOJ Sets Its Sights On Forest Laboratories”

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  1. Bipartisan Effort to Amend the False Claims Act : HEALTH REFORM WATCH says:
    03/14/2009 at 7:12 am

    [...] At the very least, the proposed amendment, which would facilitate the use of qui tam actions, is further evidence of the federal government’s increased reliance, and an intention to continue in such reliance, up…. [...]

  2. Family-Run Medical Equipment And Billing Companies Enterprise Lead To Prison Time : HEALTH REFORM WATCH says:
    03/23/2009 at 8:04 pm

    [...] As we have noted in prior posts, there seems to be an increased governmental reliance upon qui tam actions, which rely, at least initially, upon the prosecution of claims by private citizen “whistleblowers” in pursuit of “bounty.” The question is: what happens if no one blows the whistle? [...]



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