WASHINGTON — While foreign companies make more and more of the United States’ drugs, U.S. inspectors visit the sites just once every eight to 12 years on average, according to congressional investigators.
That’s far less oversight than domestic producers face.
Prescription drugs and drug ingredients pour into the United States from an estimated 3,000 foreign companies, though the real number is unknown and could be as high as 6,700, the inspectors said in a memo to members of the House Energy and Commerce subcommittee on oversight and investigations. The memo was released Wednesday.
The Food and Drug Administration plans to inspect just 300 of those thousands of firms this year, announcing in advance its intent to do so each time. Of those inspections, most are of plants that make drugs awaiting FDA approval. Just 15 are of the type of periodic assessment meant to ensure a company’s products remain safe in the years following FDA approval, though some pre-approval inspections also include some post-approval surveillance.
Federal law requires the roughly 3,300 domestic drug manufacturers to be inspected, often unannounced, once every two years – something the FDA does come close to doing. There is no such legal requirement for foreign makers.
“Given the potential risk from foreign sources, this places an unacceptable risk on the public,” said Rep. John Dingell, D-Mich., the committee’s chairman.
That discrepancy, along with other issues surrounding the FDA’s ability to monitor the safety and purity of imported drugs, will be the subject of a congressional hearing today.
Some manufacturers are already crying foul.
“If you’re not being inspected, is there really a regulatory scheme at all? Foreign manufacturers are able to not have to worry about inspections and perhaps not follow the rules as they’re supposed to – and domestic manufacturers want to play by the rules, have to play by the rules and are inspected to the rules,” said Gregory Minchak, a spokesman for the Synthetic Organic Chemical Manufacturers Association, a trade group that has set up a task force to represent U.S. makers of active pharmaceutical ingredients. It estimates foreign manufacturers are visited even less frequently, just once every 14 years on average.
An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad.
