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Wednesday, June 01, 2016

Do You Know How the FDA Approves New Medications? It’s Time You Learned!

Over the years there have been so many FDA approved medications that have been pulled from the shelves that it leads many to wonder how they were ever deemed safe for the general public in the first place. If you or a loved one has been prescribed a ‘new’ medication that you are unfamiliar with, and even those you’ve heard of before, it pays to know a little bit about how the FDA approves new medications safe for use in the United States. With drug after drug being recalled and class action suits filed against the manufacturer, like the recent Xarelto Lawsuit filed against Bayer AG and Janssen Pharmaceuticals, consumers should know how the medications they take actually reach their pharmacists’ shelves.

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Center for Drug Evaluation and Research

The group within the Food & Drug Administration (FDA) that has the final say on whether or not pharmaceuticals are safe to be sold in the U.S. is the Center for Drug Evaluation and Research, CDER. By the very name of the group you would think that the FDA has gigantic laboratories equipped to thoroughly test every drug that applies for patent and to be sold here in the U.S. Unfortunately, this really isn’t the case.

Research Is Not Conducted by the FDA


Where consumers go wrong is in thinking that the FDA employs thousands of scientists and research assistants to conduct studies on each and every medication that comes across their ‘desk.’ Unfortunately, this is simply not the case. CDER does limited testing only after the medication (or supplement) has been studied by the manufacturer and that particular formulation meets with the FDA’s requirements. But does it really? Since the FDA, or CDER to be exact, does not do the testing for efficacy and safety, they are pretty much operating on the assumption that the testing conducted by the manufacturer and/or third party laboratories is thorough and accurate. The only research conducted by CDER is usually in terms of quality control. In effect, what the government is looking for is problems in the process not in the safety or efficacy of the drug.

Consumers Can Pay More than They Bargained For

If all the necessary paperwork required by the government is in order and the manufacturer appears to have tested the drug in compliance with FDA guidelines, most pharmaceuticals are approved for sale in the United States. CDER’s Office for Testing, as mentioned above, will do sporadic quality control tests but does not test for safety. Consumers should be made aware of the fact that they are, for the most part, taking the word of the manufacturer who of course wants to sell that drug for profit. Consider the fact that a pharmaceutical company most likely invested tens of millions, if not hundreds of millions, of dollars in producing the formulation so they want to profit from their investment. But at what cost?

Are FDA Guidelines Strict Enough?

This is not to say that a manufacturer knowingly withheld pertinent information from the FDA when seeking approval for their new medication. Many times it took being released to millions of people to realize the full extent of potential side effects. Whether the pharmaceutical company fell short on their ethical responsibilities or the required testing wasn’t sufficient to find those exceptions to the norm isn’t really at issue here. The point is, consumers are led to believe that the FDA approved each and every drug after doing their own independent studies and this is just not the case.

Consumer beware. Do your own research before taking any new medication because there may already be problems reported that you should be aware of. If you don’t take your own safety into your own hands, who will?

This is a guest blog post.

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