A recent review of the U.S Food and Drug Administration reveals that only a small percentage of <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug trials conducted overseas are being reviewed by the agency, said The Associated Press (AP). With more and more drug testing activities being conducted outside of the United States, this presents a potential problem, the AP added.
The FDA has been making headlines for problems such as inadequate foreign drug manufacturer inspections, uneven drug trials, and drug and drug component contamination. With the global manufacturing of pharmaceuticals, come the global problems and the related regulatory lapses.
According to the report, during fiscal year 2008, only about one percent of all foreign drug sites were tested by the FDA, said the AP, noting that the report was issued yesterday by the Inspector General for the Department of Health and Human Services (HHS). It seemed, according to the report, that in many cases, the agency did not know about so-called early-stage trials taking place in foreign countries such as South America and Central America, said the AP.
We have been writing about this issue for some time now, also noting that drug makers are increasingly outsourcing the running of clinical trials to outside companies, known as Contract Research Organizations (CROs). Clinical trials are meant to test the safety and efficacy of experimental drugs before they come to market. Yet despite the importance of such studies, CROs operate with very little regulatory oversight. Also, an increasing number of such studies are being conducted in foreign countries, where the FDA has limited authority. This means pharmaceutical companies must be counted on to oversee the CROs they hire and the countries in which trials are taking place; however, no one knows if they are doing this adequately.
According to the AP, firms such as Pfizer Inc. and GlaxoSmithKline PLC have broadened their patient populations to both lower costs and provide more expansive demographics to their researchers. Although Western Europe is the biggest area for such testing, with 58 percent of patients enrolled in such trials, the AP said that the investigation revealed that South and Central American countries had the greatest number of patients per site. According to the AP, this could point to drug makers seeking to lower costs.
“The quality of the data used by the FDA as a basis for approving the drugs being studied may well be flawed, resulting in dangerous, incorrect decisions to approve drugs,” said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, quoted the AP.
Meanwhile, the HHS reports indicates that some 80 percent of drug approvals in fiscal year 2008 had some basis in foreign studies and that eight percent of all drug approvals relied only on foreign information, said the AP.
The HHS suggested that the FDA better collaborate with foreign governments and should mandate that drugmaker submit trial information on a standard and electronic format, said the AP.