FDA Commissioner Says FDA’s Once-Every-Twelve-Years Pace of Inspecting Foreign Drug Manufacturers is Unacceptable

By Matt Cover | July 31, 2009 | 6:09 PM EDT

FDA Commissioner Margaret Hamburg

(CNSNews.com) - Margaret "Peggy" Hamburg, commissioner of the Food and Drug Administration, told CNSNews.com that it is not acceptable for the FDA to inspect foreign drug manufacturers only once every 12 years and domestic manufacturers every three years.
Touring Washington, D.C.’s Eastern Market with Health and Human Services Secretary Kathleen Sebelius and Agriculture Secretary Tom Vilsack on Friday, Hamburg said that her department’s performance in inspecting drug manufacturing facilities was not acceptable, and that her goal was to turn the FDA into a world class regulator, working with both foreign and domestic partners to better keep tabs on drug makers.

“No,” she said. when asked if the FDA's fequency of inspecing foreign drug manufacturers was acceptable. 

“The numbers of [overseas] producers is huge, hundreds of thousands, and we need to really have a strategic framework," she said. "We need to work with other partners in terms of our sister regulatory agencies. We need to work with the regulatory agencies in those countries and with industry to figure out how we can really enhance the oversight of the production of really important products that are being imported from overseas.”
Hamburg said that her agency was dealing with limited resources and a growing number of drug manufacturers, making it much harder to inspect them regularly.

“We clearly want to expand our global footprint,” she said, “and take a very strategic look at how---with obviously limited resources and an expanding demand in terms of overseas producers of drugs and medical devices” that the FDA could achieve better and more frequent inspections.

When asked how this goal would be affected by President Barack Obama’s efforts to have the government restructure the health care system, Hamburg demurred, saying only that health care reform would affect everyone in America. She added that there were a set of issues that were not related to health care reform, but declined to explain whether FDA inspections were one of them.
“Health care reform is very important,” she said. “It’s going to make a real difference in the lives of every American. But there are a set of issues that lie outside of what health care reform is addressing and things like ensuring the safety of the food, drug, and medical product supply is something that FDA needs to take a leadership role on, working with industry.”
The Government Accountability Office (GAO) published a report in June that said the FDA is only able to inspect foreign drug manufacturing facilities an average of once every 12 years and domestic drug manufacturing facilities once every three years.
As CNSNews.com previously reported, the GAO found that the only foreign drug makers the FDA inspects are those making prescription medications, not over-the-counter drugs, which are often the first ones people use to relieve their symptoms.
The FDA does not conduct inspections of foreign facilities manufacturing over-the-counter drugs because it does not consider that a priority compared to inspections of prescription drug makers.
“FDA primarily conducts inspections of establishments manufacturing prescription drugs, as opposed to over-the-counter drugs, because FDA generally considers establishments manufacturing over-the-counter drugs to have a lower inspection priority,” the report stated.
The report further said that FDA does not even have a requirement for how frequently foreign tissue banks, drug, and device manufacturers should be inspected, listing all three under the heading “establishment types without a requirement for inspection frequency.”
Foreign tissue banks are inspected only once every four to five years, and foreign makers of high-risk medical devices such as heart valves and pacemakers once every six years. Makers of medium-risk devices such as hearing aids and electrocardiographs are inspected only once every 27 years, according to the GAO.