Of interest: Unapproved drugs are used by 2% of US Rx's

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http://www.pharmacytimes.com/articleNewsletter.cfm?ID=3934

October 19, 2006

Most people assume that when their doctor prescribes a medicine it has

received the blessing of the federal government. Some have learned the

hard way that this is not always the case.

Stealth Drugs Fly into Pharmacies Under FDA Radar

K. Bodine, Assistant Editor

A recent report by Bloomberg.com found that almost 2% of prescriptions

(as many as 73 million) dispensed in the United States in 2005 were

for medicines that had not been approved by the FDA. A few of these

medications are legal because their ingredients are " generally

recognized " as " safe and effective. " The FDA is planning to crack down

on the majority of unapproved drugs, claiming that they are not only

illegal, but that they may be dangerous for patients. Most of the

companies that sell unapproved medicines are privately held, with

fewer than 500 employees. When these companies register their products

with the FDA as they go to market, they are able to skip the approval

process entirely. Surprisingly, it is legal to prescribe and dispense

these unapproved drugs and to have them covered by insurance. Doctors,

pharmacists, and health insurers usually are unaware of the unapproved

status, as many of these drugs are promoted through the Internet,

journals, and salespeople, and the drugs' names and packaging do not

mention their unapproved status. Most of those involved say that they

assume the medicines are approved. Yet, some insurance company

personnel who do know they are not approved still agree to pay for

them.Another factor that could mislead prescribers is the drug

companies' ability to list these medicines in the Physician's Desk

Reference, which does not require proof of FDA approval for its

listings. These medicines can contain combinations of ingredients that

were used in drugs that had been previously approved by the FDA. New

doses, combinations, and prescribing instructions in the unapproved

versions can pose serious risks, however.Unapproved drugs have proven

harmful in the past. In April 2006, more than 100 unapproved medicines

containing the antihistamine carbinoxamine were on the market. Many of

these products permit its use in children under the age of 2

years—despite the deaths of 21 children over the past 23 years who

received the medicine. In June 2006, the FDA ordered companies to stop

making unapproved products with carbinoxamine, but it failed to order

a recall of the medicines, which still may be on pharmacy shelves.

Deborah M. Autor, director of the office of compliance at the FDA,

stated that the agency is " committed to ensuring that all drugs in the

United States meet safety and effectiveness standards. " Galson,

MD, director of the FDA's Center for Drug Evaluation and Research,

said, " Unapproved drugs may not meet the modern standards for safety,

effectiveness, quality, and labeling. Clearly, this is a problem we

intend to fix. " Talk to us!For other articles in this issue

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Groups to Help Seniors with Medicare Part D