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FDA Proposes Rules for Disseminating Data on Off-Label Uses

FDA Proposes Rules for Disseminating Data on Off-Label Uses

ROCKVILLE, Md--The Food and Drug Administration (FDA) has proposed rules that would give manufacturers greater flexibility in disseminating information about the safety, effectiveness, or benefits of "off label" uses of drugs, biologics, and medical devices. The new regulations will implement provisions of the FDA Modernization Act of 1997, enacted last year.

If the new rules are approved, pharmaceutical companies will no longer have to wait until the FDA approves their supplemental applications before providing health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, and federal and state agencies with reliable information about unapproved uses of their products.

  • The new rules would apply, provided the material:

  • Concerns a drug or device already approved, licensed, or cleared for marketing by the FDA.

  • Is an unabridged reprint or copy of a peer-reviewed scientific or medical journal article, or unabridged reference publication, about a clinical investigation that is considered scientifically sound by qualified experts.

  • Does not pose a significant risk to the public health.

  •  Is not false or misleading.

  •  Is not derived without permission from clinical research conducted by another manufacturer.

  •  Includes certain disclosures (including the fact that the FDA has not approved the new use), the official labeling, and a bibliography of other articles relating to the new use.

Before an Application is Submitted

The FDA would also permit a company to circulate information before submitting a supplemental application, providing it has:

  • certified that is has completed the necessary studies and that a supplemental application will be submitted within 6 months, or

  •  provided an adequate protocol and reasonable schedule for the necessary studies and certified that the application will be submitted within 36 months, or

  •  received an exemption from the requirement to submit an application on the grounds that the necessary studies would be unethical or economically prohibitive.

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