Expedited Review and Approval of Drugs May Compromise Safety
According to Reuters, a recent study has found that clinical trials for drugs that go throught the Food and Drug Administration's expidited review and approval process may not be producing enough applicable data to ensure patient safety or drug efficacy.
About the FDA Expedited Review and Approval Process
The FDA has received a high degree of pressure from Congress, the drug industry and patient groups to speed up the process and release break-through drugs as soon as is legally possible, but data suggests the expidited approval for “innovative” drugs does carry significant risks.
In a study conducted by Thomas Moore and Dr. Curt Furberg, both medical scholars, researchers analyzed the development time frames, clinical testing and risks associated with the expedited review and approval process of drugs. The scholars conducted this research on 20 drugs released in 2008, eight of which were given expedited review.
The expedited review of drugs was found to be clinically tested over a period of 5.1 years, while standard review drugs were tested over a 7.5 year time period. However, researchers found that many safety monitoring trials' post-approval were not completed, not submitted to the FDA or not done at all.
In fact, of 85 follow-up trials mandated by the FDA to observe safety, only 40% of these trials have been conducted possibly exposing patients to serious side effects not mentioned on the drugs' warning lables.
The FDA expressed in a statement that, “the expedited development programs are working as intended by getting promising new drugs to patients more quickly.”
FDA Gives Leniency on Data it Accepts
The FDA has generally required two controlled clinical trials to prove the safety and efficacy of a drug, but has more recently allowed some drugs to get approved with only one controlled trial.
One of the main reasons for this slack in testing, data, and expedited approval is the higher assumption of risks that patients and doctors are willing to take to get immediate and break-through treatment.
Further, the FDA is considering taking additional measures to expedite the drug development process itself, by utilizing “enriched” trials.
These trials select patients based on particular demographic and/or genetic characteristics in order to increase the chances of success in a trial. The point of this being the improvement of treatment for those who can most benefit and respond to a particular drug.
However, doubts have been raised as to whether the FDA has established adequate measures to ensure that drugs that are approved based on limited populations are only marketed to those segments of the population.
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