FDA Shortens Drug Approval Time, Raises Questions

November 7, 2013 | Crandall & Pera Law
FDA Shortens Drug Approval Time, Raises Questions

As the Food and Drug Administration expedites reviews, many safety questions are left unanswered about new drugs even after they are approved, according to a study in the Journal of the American Medical Association.

In an examination of 20 new drugs approved by the FDA in 2008, it was found that eight were given expedited review (5.1 years of clinical testing) and 12 standard review (7.5 years). But, in many cases, safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted, not completed or not submitted to the FDA.

Of the drugs studied in 2008, the FDA required 85 follow-up trials to monitor for safety. By 2013, only 40 percent of those studies had been completed.

"The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population with extensive additional testing conducted after approval," the study's authors said.

While patient groups and drug companies applaud these measures in order to get medications into the hands of patients more quickly, critics say the FDA is approving products before they have been fully vetted. Read the full details here:

FDA's shorter approval time for new drugs raises questions

This article demonstrates how important it is, when prescribed medication or given any medical advice, to ask questions and do as much research as possible.

If you or anyone in your family has suffered serious side effects or damages from a medication error you should seek legal investigation immediately. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.