A new tactic for the FDA - Are they overstepping their authority?

Apr/11/2007 06:31 Filed in: Pharma Business
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The Food and Drug Administration said proposed prescription painkillers should fill an unmet medical need for patients who have no other "relatively safer" alternatives, suggesting Merck & Co.'s bid to have a Vioxx-like successor drug approved in the U.S. faces a tough road. But who is to say that a new drug fills an unmet medical need for patients who have no other "relatively safer" alternatives ? This author feels that this action by the FDA is a dangerous precedent that could quickly lead to major issues for consumers, insurers and pharma companies.


I used to take Celebrex for joint pain until I read information on the Celebrex website that said one of the potential side effects could be "intestinal bleeding or death". When I first received the Rx for Celebrex I received a letter from my health insurer informing me that OTC Ibuprofen (store brand no less) worked just as well as Celebrex and costs a lot less. I switched to Advil but the key point here is that it was MY decision based upon the risks I was willing to take from information on all types of pain relievers.

I know, as all consumers should know, that all prescription medications have risks and potential side effects. I can work with my HCp to determine what is best for me but at the end of the day I am the one who makes my healthcare decisions. To be honest Celebrex worked better for me on my joint pain than OTC products but I did notice some stomach discomfort when I used Celebrex. Rather than risk what I perceive to be more serious problems I decided that ibuprofen will work well while not providing any possible GI problems. I don't want the FDA making these decisions for me I want to make them myself with input from my HCP and no amount of DTC advertising is going to change my mind. DTC ads may enlighten me as to new products or treatment options but I am the one who will go to the product.com website and look at the side effects and warnings to determine if the risk is acceptable for me.

The FDA obviously does not believe that consumers are smart enough to research products on their own even though traffic to health websites, including prescription medications, keeps increasing. Under this new guideline, unmet medical need for patients who have no other "relatively safer" alternatives, products like Ambien might not have made it to the market. If Pfizer informed the FDA that Lipitor, the world's biggest prescription drug, patients were reporting more side effects would the FDA require Pfizer to take it off the market in favor of other cholesterol lowering medications?

This is wrong direction for the FDA to take. Instead they should be working with the drug industry to continually educate and inform consumers about the risks of approved prescription drugs. They should not determine if other "safer alternatives" are available because under that guideline some supplements may work better than prescription drugs with less side effects thus the Rx should be taken off the market. Consumer have the power now and we don't need the FDA to limit the choices WE want to make in OUR treatments.

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