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
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.