Thomas J. Moore of the Institute for Safe Medication Practices in Alexandria, Virginia and Dr. Curt D. Furberg of the Wake Forest School of Medicine in Winston-Salem, North Carolina published a new analysis of the United States Food and Drug Administration (FDA) practices for expedited drug approval and follow-up testing in the Oct. 28, 2013, issue of the journal JAMA Internal Medicine.
The researchers looked at expedited drug approvals in 2008, the first year that present legal statutes became active for the expedited testing and approval of drugs that was intended to make new drugs and therapies available faster if and only if the new drug or therapy would be a significant therapeutic advancement or fulfill unmet therapeutic needs for serious illnesses.
The researchers found that the FDA gave marketing approval to eight drugs in the expedited format. These eight drugs had 68 percent of the clinical development study time that standard drug review dictates and were tested on 18 percent of the number of human volunteers that standard drug review permits. The eight expedited drugs were 40 percent of all drugs approved by the FDA in 2008.
After five years all the post-marketing research for the eight expedited drugs had not been completed as dictated by law.
The FDA has taken no action to force the manufacturers to insure the expedited drug safety and efficacy by completing post-marketing research.
The FDA is one of the most heavily lobbied groups in Washington. The possibilities that expedited drugs that pose serious potential health risks are released due to the influence of the record amounts of money that pharmaceutical manufacturers spend lobbying the FDA may be the reason expedited drugs do not get the necessary follow-up research in an expedient time frame.