FDA Drug Approval Process

Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

What is novel therapeutics? Novel therapeutics are central to any debate since these therapies most likely represent advances in care, although there is variation in the degree of innovation among novel therapeutics, ranging from first in class therapeutics that address unmet public health needs to me too drugs.

From 2001 to 2010, the FDA reviewed applications on average more quickly than did the European Medicines Agency or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States.

Again, if you know there is a drug helping people in other parts of the world but you cannot have access to the medication – it would be bad news. So many unsafe drugs like Topamax, Effexor, Fosamax, Actos, and more perhaps could benefit by a longer approval process because the drug makers take an extremely long time for black box warnings to be changed and/or to be recalled from the pharmaceutical marketplace.

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