Published March 21, 2011 in Washington Drug Letter
ATHENS, Ga. — Companies that have a track record of non-compliance with good manufacturing practices would come under greater FDA scrutiny and would be more likely to get inspected, the FDA’s associate commissioner for regulatory affairs has suggested.
Speaking Tuesday at the International Good Manufacturing Practices Conference, Dara Corrigan said the FDA must “be able to shift our resources to the high-risk areas, which means the high-risk companies.
“We should be looking at those companies with a history of non-compliance. They deserve more scrutiny, and they will have more scrutiny. And we are looking at ways to better track a company’s history over time.”
Corrigan didn’t elaborate on how the FDA would handle or examine a company’s history, but said there should be rewards for those companies who meet or exceed standards.
“We need to have a way of looking at those [companies] and really assessing where the risk is,” said Corrigan, who took office in September and oversees a field staff of roughly 4,000 inspectors. “Good companies deserve FDA’s respect.”
Corrigan noted a 42 percent increase in the number of warning letters issued between fiscal 2010 and fiscal 2009. More than two-thirds of warning letters issued in fiscal 2010 were issued within a four-month period.
Warning letters, however, aren’t always a good metric for the amount or quality of compliance enforcement the FDA does, she noted.
Corrigan acknowledged FDA Commissioner Margaret Hamburg’s work to cooperate with foreign governments and inspectors to better ensure the quality of products made overseas and shipped to the U.S.
The agency recently joined the 37-member Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, and now has confidentiality agreements with 20 countries. The FDA also has foreign offices in China, India, Latin America and Europe, but Corrigan admitted there needs to be improvements with the offices. A GAO report last year also suggested improved coordination is needed between the FDA’s overseas offices as well as long-term strategic planning (WDL, Nov. 1, 2010).
“There is a very current debate in FDA to figure out whether we should actually place more people overseas versus having to fly them out,” she said.
The GAO report found that while on the rise, the number of inspections of foreign plants pales in comparison to those done on domestic facilities (WDL, Nov. 1, 2010).
Corrigan, said the FDA has many new inspectors and is working hard to get them trained.
About 40 percent of her department’s work force is new investigators hired in the last three years. “A lot of these investigations and inspections are complicated, especially in drug manufacturing,” she said. “It takes a while to get people up to speed.”
Last month, Deborah Autor, director of the FDA’s Office of Compliance, said that a lack of resources to conduct foreign inspections is part of the reason why the agency has a huge backlog of ANDA applications (WDL, Feb. 21).
The FDA also needs people devoted to high-level drug inspections. “We’re creating a cadre of specially-trained professional inspectors,” Corrigan said. — David Pittman