Friday, August 21, 2009

WHO good FDA bad

Well maybe. The WHO is not a US based organization and the FDA is. WHO is issuing an "advanced take care of the people and keep them alive policy". FDA warningThe FDA has an "if we haven't approved it and people might die you can't market it policy". Food and Drug Administration has asked the marketers of topical ibuprofen products which aren't FDA approved to remove them from the marketplace. On the surface safe and effective is an important criteria for any medication however if the amounts don't exceed the amounts of oral ibuprofen products why should there be a problem? Have there been consumer or physicians complaints of the products? None of which are addressed in the FDA warning to the producers.

WHO is international so when we sought other international agencies or organization use of topical ibuprofen and lo and behold we discovered that in the UK physicians after a year long study discovered that topical use is cost-effective with less adverse effects. These are what we consider magical words when it comes to health and treatment. Other studies from other countries have been published since 2001, 2002, 2005, 2006, 2007 demonstrated the use and safety of such products.

These are studies weren't published in industry publications by the producers but was published in the May 2008 journal of Rheumatology as were many of the other cited research in other nations. Should the producers be punished because of the ineffectiveness of the FDA? We think not if the FDA can't keep up and isn't responding to the needs and concerns of the health and welfare of its tax paying owners then the FDA needs a warning. Let this voice be the first to add its timbre to the cry for better and more employee accountability from the FDA.

Here's what the FDA had to say in their warning letter in one of their I don't care what they said its what I say moments: “These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research." "...There are no approved applications for topical ibuprofen products..." "...safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products."

When the government is low on funds and personnel are being reduced, in a country where small businesses help the economy grow, warning producers who can contribute to a healthier economy and society is a waste. This use of government authority is an abuse of power. Where is the established danger to individuals where someone has died or been injured? In this country where citizens who are not abusing medication but by using medications are suffering death and injury this kind of oversight is unwarranted, unneccesary and unneeded. If the FDA has the power to fine then fine we need the money. Save the warnings where they are warranted.

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