Study Questions FDA Approval Time
All legally sold medications need to be approved by the U.S. Food and Drug Administration (FDA) before they get onto the market. The FDA typically follows a set of guidelines when reviewing the safety of a new drug. However, for some drugs, the FDA might take a faster approach in approving it due to the certain conditions. In a new study, researchers examined the difference between expedited review and standard review of drugs.
For this study, the researchers headed by Thomas Moore from the Institute for Safe Medication Practices and Dr. Curt Furberg, a professor from Wake Forest School of Medicine looked over 20 drugs that were approved in 2008. Eight of the drugs went through expedited review and 12 went through standard review. The team found that drugs that went through the expedited route took a median of 5.1 years to get FDA approval whereas the other drugs took 7.5 years to be approved.
"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 authors said according to Reuters.
Drugs that have been approved need to go through safety monitoring trials after. However, this report found that many of these trials are never conducted, completed or submitted to the FDA. The authors stated that of the 20 drugs in the study, the FDA had asked for 85 safety follow-up trials. As of 2013, only 40 percent of those trials have been completed. The authors stressed the importance of making sure drugs are safe enough to be on the market. However, they believe that the faster approval time could be due to patient groups' demand. Patients who have no other options left will most likely push for a drug that could potentially save their lives even if the clinical trials were small.
The FDA stated, "It shows that the expedited development programs are working as intended by getting promising new drugs to patients more quickly. In situations of serious and life-threatening diseases with unmet medical need, patients and physicians who treat them have told us repeatedly that they are willing to accept greater uncertainty about risk in order to have access to the hope of improved treatment today."
The report was published in JAMA.