A recent proposal by the Food and Drug Administration will have a significant impact on the sale and marketing of drugs, including biologics and medical devices.
This means pharmaceutical marketers can have more latitude in communicating about "off-label" drug uses to consumers. "Off-label" refers to drug benefits that are not included in the approved labeling of a drug or device by the FDA.
Under the pending rule change, manufacturers and marketers (referred to in the proposal as "sponsors") of these products will have greater flexibility to disseminate additional information about the drug's safety and effectiveness.
These "unapproved" or "off-label" uses can include:
- a completely different indication;
- modification of an existing indication that can range from a new dose and dosing schedule to a different duration of usage and a new age group;
- effectiveness for a sign or symptom of the disease not in the current labeling; and
- comparative claims to other agents for treatment of the same condition.
The information may be disseminated to healthcare practitioners, pharmacy benefit managers, health insurance issuers, and group health plans.
The proposal recommends that manufacturers and sponsors would not have to wait until the FDA approves a supplemental application before disseminating information about off-label uses as long as the information:
- concerns a drug or device that has been approved, licensed, or cleared for marketing by the FDA;
- is in the form of an unabridged reprint or copy of a peer-reviewed scientific or medical journal article, or an 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; and
- includes certain disclosures (e.g., that the new use has not been approved by the FDA), the official labeling, and a bibliography of other articles from scientific reference publications or journals relating to the new use.
A company that relies on this rule would have to submit to the FDA, 60 days prior to dissemination, a copy of the information to be disseminated, as well as certain other information on an ongoing basis.
In addition, a company that has not submitted a supplemental application for the new use could begin disseminating information if it certifies that it has completed the necessary studies and that a supplemental application will be submitted within six months.
The proposal also recommends that an adequate protocol and reasonable schedule for the necessary studies will be provided.
Manufacturers and sponsors would have an ongoing responsibility to provide the FDA with additional information about the disseminated new uses or the FDA could order a halt to the dissemination of additional information.
Despite the details provided in the proposed rule, which the FDA intends to finalize by November 21, 1998, there are numerous issues that manufacturers and sponsors need to consider and analyze before disseminating information about off-label uses, that includes:
- when a clinical investigation for an off-label use is scientifically sound;
- what constitutes "promotional" information that may not be disseminated with the reprint, article or reference text; and
- how the required disclosures should appear on the information. Michael E. McDermott, a partner with the Farrell Fritz law firm in Long Island, N.Y. The firm represents hospitals, physicians, managed care and other healthcare providers in general corporate, regulatory, administrative, and operational matters. He can be reached at (516) 227-0700.
Record Growth In Prescription Sales
Overall prescription sales volume grew 17.6% for the second quarter of 1998, setting an industry record, according to IMS Health, a national provider of pharmaceutical information in Plymouth Meeting, Pa.
The record growth surpasses the 17.3% increase recorded in the third quarter of 1997. By comparison, the peak annual growth rate recorded during the late '80s was 15.5%.
Prices for brand pharmaceuticals rose by 4.3% in the second quarter of 1998, versus the same quarter in 1997.
However, there was a decrease in generic drug prices of 5.1% in the second quarter of 1998, compared to the same quarter last year. (IMS Health, Gary Friend, 610/834-5654)