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Pharmaceutical industry

FDA and DOJ Crack Down on Off-Label Drug Use by Pharmaceutical Companies

Strategic Insights

— 1 min read

Pharmaceutical companies are increasingly facing prosecution for encouraging non-approved uses of drugs, with the Department of Justice (DOJ) focusing on marketing and sales practices that promote off-label use. Virginia Gibson, Associate U.S. Attorney for the Philadelphia area, stated that the DOJ is interested in companies that initiate and encourage off-label trials, particularly if they offer financial incentives or have a history of corporate pressure to increase sales. A recent case involving Parke-Davis's promotion of the off-label use of Neurontin (gabapentin) resulted in a $430 million out-of-court settlement. Companies are being scrutinized for their involvement in clinical trials, with warning signs including marketing departments designing studies, false or forged consent forms, and incomplete disclosure of company involvement or potential risks.

Key Takeaways:

  • The DOJ has begun to prosecute companies for encouraging non-approved uses of drugs via the False Claims Act, with a focus on marketing and sales practices.
  • The agency is interested in companies that initiate and encourage off-label trials, particularly if they offer financial incentives or have a history of corporate pressure to increase sales.
  • Parke-Davis paid $430 million in an out-of-court settlement for promoting off-label use of Neurontin (gabapentin).
  • The DOJ is looking for warning signs such as marketing departments designing studies, false or forged consent forms, and incomplete disclosure of company involvement or potential risks.
  • Companies like McNeil Consumer and Specialty Pharmaceuticals are taking steps to prevent marketing involvement in clinical trials, including using a multidisciplinary approach and keeping marketing involvement in check.
  • Whistleblowers have become the primary source of fraud cases, with health care recoveries exploding as a result of prosecuted cases.

Statistics:

  • $430 million: The amount Parke-Davis paid in an out-of-court settlement for promoting off-label use of Neurontin (gabapentin).
  • $1.7 billion: The cost of false claims to pharmaceutical companies in 2003.
  • Since 1986: The year the False Claims Act was amended, leading to a rise in complaints of pharmaceutical fraud.

Sources:

  • Virginia Gibson, Associate U.S. Attorney for the Philadelphia area, Pharmaceutical Education Associates (PEA) conference, June 24.
  • Christa Hooper-Wood, manager of investigator-initiated studies at McNeil Consumer and Specialty Pharmaceuticals, Pharmaceutical Education Associates (PEA) conference, June 24.
  • Parke-Davis's out-of-court settlement for promoting off-label use of Neurontin (gabapentin).

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