FDA Approves Generic Enoxaparin

Abstract

But the FDA does not become involved in such oversight until a sponsor submits an Investigational New Drug Application. This creates a loophole in oversight because such applications may not be submitted for certain ongoing or early-phase trials— trials in which participants may be particularly exposed to safety risks, the OIG said. While these concerns apply equally to domestic and foreign studies, the fact that the FDA inspects foreign trials at only 37% of the rate seen domestically makes individuals outside the United States statistically more vulnerable to possible substandard safety. Also, the OIG found that the FDA was unable to provide detailed clinical trial data for 29 of the 129 applications reviewed in the report, and that the agency inspected trial sites in only 20 of 72 countries the OIG identified in those applications. How often the FDA inspects foreign trial sites is not the key issue, as the agency still plays a major role in ensuring that drug research is conducted in an appropriate manner, said Ken Johnson, senior vice president, Pharmaceutical Research and Manufacturers of America. “Regardless of the location, however, companies seeking US approval must maintain the FDA’s high standards for conducting the trial,” Johnson said in a statement. “For instance, any related trials conducted outside the US must comply with FDA requirements covering good clinical practices, in addition to meeting the requirements mandated in these important emerging markets.” To improve oversight of foreign trials, the OIG suggested that the FDA continue to develop inspection agreements with foreign regulatory bodies, inspect in more countries, and look to new models of oversight. A spokesperson for the FDA said the agency is already tackling the problems: “The agency already has several initiatives under way to improve FDA’s oversight of clinical trials conducted internationally, including sharing inspection information with foreign regulatory authorities, engaging in broader outreach with other countries around the world, and developing an analysis tool for efficiently identifying foreign and domestic sites for inspection.” Sidney Wolfe, MD, director of Public Citizens Health Research Group, expressed skepticism that the FDA will follow through on its initiatives. He pointed to its poor track record in inspecting pharmaceutical manufacturing plants in foreign countries and its apparent lack of effort to seek more funding to improve its factory inspections. “That showed a lackadaisical attitude on the part of the FDA,” Wolfe said. “The FDA . . . has not been assertive in seeking funding to improve such inspections.”