"Off-label" prescribing is the practice by which pharmaceutical drugs approved for one use by the Food and Drug Administration (FDA) are prescribed to patients for use in connection with other diagnoses.

Obviously, the more conditions a drug is prescribed for, the more of it will be sold and the more money its manufacturer will make. FDA rules require that a drug be proven to be "safe" and "effective" in the treatment of the condition for which it was approved. It doesn't need to be proven to be either safe or effective when used to treat other conditions, however.

On May 13, 2004, the National Association of Attorneys General (NAAG) issued a press release entitled "Settlement: Fifty Attorneys General Announce Settlement with Pfizer Over Improper Off-Label Drug Marketing".

The settlement includes provisions requiring Warner-Lambert (a wholly-owned subsidiary of Pfizer Inc., the largest drug company in the world), to pay $430 million to state and federal authorities and to desist from what Oregon Attorney General and Vice-Chair of the NAAG Pharmaceutical Pricing Task Force Hardy Myers called "its unethical and illegal practice of off-label marketing" of its Neurontin® drug product.

Under the terms of the settlement, Warner-Lambert is required "to fund a unique $28 million program to correct the problems associated with direct marketing by pharmaceutical manufacturers to doctors and other prescribers." Of that amount, "at least $21 million dollars will be used for programs that provide prescribers and/or consumers with fair and balanced information about drugs. In addition, up to $6 million dollars will go toward a National Advertising Program to provide physicians and other prescribers with fair and balanced information about Neurontin and other drugs in its therapeutic class. Finally, up to $1 million dollars of the fund will be utilized to evaluate the effectiveness of the remediation program."

These provisions sound like "academic detailing" on, if you'll pardon the expression, steroids.

At a time when one of the most important and effective means of marketing drugs is to advertise them directly to consumers in print and television advertisements and urge potential customers to "ask your doctor" about Drug X, no provision seems to have been made in this settlement to require the offending party, Warner-Lambert, to spend anything on direct advertising telling potential users about alternative means of treating their problems.

The significance of this settlement, however large it may be, is that it could very well set a precedent for additional lawsuits and settlements regarding the "off-label" marketing of other drugs, such as the SSRIs (Paxil, Zoloft, Prozac), all of which are being prescribed for a wide range of perceived ailments beyond those for which they have been approved by the FDA.

As stated in the National Cancer Institute material linked to above:

"However, the FDA - although responsible for ensuring that a treatment is safe and effective for the specific approved indication - does not regulate the practice of medicine. This means that once the FDA approves a treatment, licensed physicians can prescribe it for any purpose they consider medically appropriate.

"An off-label use of a product can cease to be off label if the product's maker submits a supplemental application and obtains FDA approval for the new use. The FDA encourages, but does not require, drug makers to do this.

"To submit a supplemental application, the drug maker must conduct studies to show that the product is safe and effective for the proposed new use. Unless the drug company expects to gain a significant commercial benefit from expanded approval of a drug already on the market, it may decide not to invest time and money in such additional studies."

Under the terms of the settlement, Warner-Lambert and its corporate parent Pfizer Inc. are prohibited from:

"failing to comply with the Pharmaceutical Research and Manufacturers of America Code with respect to payments, gifts and remuneration to health care providers (compliance with this Code has previously been voluntary [italics added]) [and]

"failing to comply with Accreditation Council for Continuing Medical Education Guidelines (compliance with the Guidelines has previously been voluntary [italics added])"

Because of the possibility of similar, as-yet-undiscovered-prosecuted-or-adjudicated "off-label" marketing and prescribing abuses involving other powerful and profitable pharmaceutical products, perhaps it would be advisable, and more fair, to require ALL drug companies to adhere to the provisions of the anti-bribery and truth-in-education guidelines that now only Pfizer is forced, under the terms of its settlement, to obey.

Additionally, it might be advisable, fair, and a good antidote to future lawsuits, to require, rather than allow, drug companies to prove that their drugs are safe and effective for each and every purpose for which anyone might want to market, sell, prescribe, or use them.

Ending the practice of "off-label" prescribing (and marketing) by requiring that a drug be proven to be safe and effective for EVERY condition for which it is prescribed, would, at the least, cost drug companies the additional expense of these additional approvals and, at worst, severely limit the range of conditions for which their drugs are prescribed, should they not prove to be safe and/or effective against problems other than those for which they have already been improved.

For both these reasons, the giant drug companies can be expected to oppose the elimination, or even the further restriction, of the off-label space with even more energy and cunning than Pfizer used when it agreed to this multi-state settlement of complaints against its wholly-owned Warner-Lambert subsidiary for its abuses and manipulations in pursuing bigger sales of Neurontin®.

To read the Morningstar.com report on how Pfizer "formally pleaded guilty Monday [today] to charges that its Warner-Lambert subsidiary violated federal law by promoting non-approved uses for one of its drugs," click here.

To vote in a poll about "off-label" prescribing and sales of pharmaceutical drugs, click here.

For more on the pharmaceutical industry and its operations, visit the Etopia Medical News Network web site.