Surprise! Unapproved Product is Unsafe.

September 24, 2008

One thing I have a difficult time in apprehending is how is it that unapproved drugs and solutions can find their way into the market place so easily? Isn’t the purpose of the Food & Drug Administration to oversee and make sure that food and drugs sold in the market are safe before they are found to be unsafe? It does not take much to know a product is unsafe when people have been hurt… Unless people are used in the testing of a product placed into the market place all with the FDA’s blessing.

All this just does not make sense to me.

Unapproved Eye Solution, Papain Drugs Cited by U.S.

The U.S. told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with both products.The Food and Drug Administration warned it may act against companies that continue to sell ophthalmic balanced salt solution for the eyes and topical drugs containing papain, drawn from papayas, without regulatory approval, the agency said today in a statement.

After years of devoting few resources to unapproved drugs, FDA officials in 2006 said they would begin to crack down on the medicines. The agency has estimated they account for about 2 percent of prescriptions.

Companies selling unapproved versions of the eye drug and lesion treatment “have bypassed the requirement of the law and put consumers at risk,” said Deborah M. Autor, director of the FDA’s drug compliance office, on a conference call with reporters.

Unapproved versions of the eye drugs have been sold by Deerfield, Illinois-based Baxter International Inc., Lake Forest, Illinois-based Hospira Inc. and B. Braun Medical Inc., part of B. Braun Melsungen AG, a closely held company based in Melsungen, Germany, according to the FDA.

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