Editorial: Off-Label Uses of Drugs

It has been estimated that 50% to 70% of prescriptions are written for "off-label" uses of drugs. What would happen if physicians could only write prescriptions for indications that are a part of the official labeling of an FDA-approved product?

Many of the prescription orders today could NOT be written. Currently, there are many uses for a large number of drugs. However, the pharmaceutical company only needs to get one indication for the drug to be approved and marketed. If a drug had to be approved for each and every indication for which it may be used, the costs would escalate or the patients would have to do without appropriate therapy. Can you imagine the clinical studies required for several indications for a single drug?

The only entity that would benefit is the FDA (Agency). By requiring more reviewers, more approvals, and more personnel, the Agency would grow and this would necessitate more funding. The Agency, like so many government agencies, seems to exist for self-preservation, growth, and power.

Would the patients benefit overall? Not necessarily. They could be deprived of medication that could alleviate pain or heal their bodies.

This also limits the role of the physician, as the number of drugs per "indication" is dramatically reduced. Consequently, a diagnosis would result in a minimal choice of alternatives for therapy.

With limited choices, which would lessen the prescription choices, the physician would become a diagnostician and not necessarily a therapeutician. The role of the clinical pharmacist is also minimized and restricted only to those drugs that are "indicated."

A worse scenario would be if penalties are imposed if an "off-label" drug is prescribed and if an "off-label" drug is dispensed or even recommended.

This situation places all health care in the hands of the pharmaceutical industry and the FDA. Obviously, the cost of health care will skyrocket, and the drugs available to patients will be decreased.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Uncle Sam, M.D.
Dr. Gottlieb (Deputy Commissioner of the FDA from 2005 to 2007). The Wall Street Journal Online; June 18, 2007.

Excerpt:

"�When it comes to medical practice, the agency's job isn't to find reasons to keep effective drugs from patients by actively managing prescribing decisions, but to surface obtainable information about risks and benefits so that patients can make informed choices for themselves."

So the article ends after discussing the role the FDA is trying to usurp from physicians in this year's Prescription Drug User Fee Act. This act will change the way drugs are used by patients through provisions that give the FDA more control of medicines AFTER they are approved. The legislation would put the FDA in the central role of regulating medical decisions in order to "manage" drug risks by giving the Agency unprecedented new authority to control the way drugs are distributed to pharmacies and prescribed by physicians. Similar to the pharmacy compounding provisions that would usurp the state's authority over pharmacy, this part of the act will usurp the state's authority over the practice of medicine.

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