FDA To Crack Down On Non-Approved Drugs

There are increasing concerns over the safety of prescription drugs, 10News investigators reported.

Despite all of the publicity and government assurances, the Food and Drug Administration does not approve many prescription drugs.

Doctors, pharmacists and patients usually have little idea that the government has never cleared many of the nation’s most commonly prescribed drugs.

So, how and why are they available in the first place?

Oxycodone hydrochloride, Phenobarbital and chloral hydrate are popular medications prescribed by doctors and given out by pharmacists. But, they are not FDA approved.

"Tackling the problem of unapproved drugs is a high priority for the agency right now," said Deborah Autor of the FDA.

An estimated 65 million prescriptions are handed out for unapproved drugs each year, according to reports. Most of the prescriptions are for cough and cold medications, sedatives and single-ingredient narcotics.

Some have been on the market for years, since before the current FDA approval system.

“Many drugs are on the market simply because the manufacturers have chosen to not get FDA approval even though they were required to do so,” said Autor.

Except in a few isolated cases, that makes them illegal. Drug development experts said the government mandates rigorous testing and strict safety standards for a reason.

"This is the way we assure that the drug supply available to consumers in the United States is relatively safe and effective," said drug development expert Kenneth Kaitin.

"I thought the FDA had to approve every drug on the market," said Sheila Elias.

Elias regularly takes medication and is now concerned all her medicines might not be FDA approved.

The medical community is concerned, too.

"Most pharmacists that you talk to would be very surprised to hear that not all prescription products are approved by the FDA," said drug information specialist Mark Lutz.

That is because the drugs are marketed and sold along with approved drugs. The drugs arrive from the manufacturers with national drug codes that say prescription only. Some companies pay to have their unapproved drugs listed in the Physician’s Desk Reference Book used by virtually every doctor. The American Medical Association said the government must start enforcing its safety standards.

"If a company is not following those rules, then they should not have the right to put medications on the market which would pose possibly unacceptable risks," said Dr. Ron Davis of the AMA.

The FDA is now cracking down, as it wants all drugs either approved or off of the market.

"We have taken action against a number of companies. We are using enforcement against companies and drugs that lack that approval," added Autor.

While there are many concerns, experts said unapproved does not always mean dangerous. For example, the FDA points to Phenobarbital, which the agency admits is useful to control seizures.

Experts advise people to talk to their doctor or pharmacist to find out if their prescription is FDA approved.

Visit www.accessdata.fda.gov/scripts/cder/drugsatfda/ to check the status of your prescription drugs.

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