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Fda Drug Companies And The Effect On The Public Due To The Speedy Aproval Of Drugs

615 words - 3 pages

About half the F.D.A.'s budget for new drug reviews now comes from Big Pharmaceutical companies. This number is due to the fact that drug companies push for faster reviews so their new drugs can hit the market. The average approval time in 2003 was about 15.9 months, while in 2004 it dropped to 12.7 months. These numbers are better than they were leading up to 2003. Where it took two years or more to approve a new drug. This time was considered to be to long and it was felt that it could cause people to die unreasonably, because a cure was available but not yet approved.With These new drugs being on what is considered to the fast track, is there any real dangers or risks? Well according to an industry group leader spokesman, Donald Trewhitt, "Over the last ...view middle of the document...

"With very little sense of concern by the industry, does the F.D.A. feel the same way? This question has been asked by many insurance companies who refuse to pay for these new drugs, and doctors who are hesitant to prescribe them. This process of quick review does not allow the time for adequate review of potential dangers. This however is ignored by the F.D.A., and many believe that it is due to large amounts of money donated by the pharmaceutical companies.The money that the pharmaceutical companies donated in 2004 was over half of the operating budget for the department. This is not in question and is considered to be helpful in Congress's eyes. The reason this is deemed helpful is due to the fact that they are not about to cut the F.D.A. budget by 50%, and the only other alternative is to raise taxes, which is also not going to happen. So this assistance is over looked as a problem, and they believe that there is no malice involved.Despite the situation with Vioxx, the FDA-approved painkiller that was pulled off the market in 2004 after studies showed it increased the risk of heart attack and stroke. These risks ate the time were considered side affects and were within there testing limitations. It is believed that these risks would have been found to be far beyond the limits if they we given the regular time to be tested. We are told though that every drug with any potency has side effects; the issue is not the side effects, it's balancing those risks against the hoped-for benefit."What can be done, or is there anything that can be done? The cases we read about, when drugs are withdrawn are situations in which new data changes that benefit-risk judgment. However, the real time truth of the matter is, that a drug will never be completely safe for all patients, and should never be perceived to be.

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