Foreign Suppliers Of Drugs Escaping FDA Scrutiny

Wednesday, October 31st 2007, 8:40 pm

By: News On 6

WASHINGTON (AP) _ Government inspectors visit the foreign companies that make more and more of the drugs used in the United States 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 Thursday. 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 manufactures 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.

The FDA's serious problems in its ability to adequately police those imports have been known for years _ the FDA itself noted as much in an internal report in 1988, and as did the Government Accountability Office (then known as the General Accounting Office) a decade later.

FDA spokeswoman Julie Zawisza said the agency uses a risk-based approach to inspecting both domestic and foreign manufacturers, ``with focus on those whose products could pose potential risk to consumers.''

But congressional investigators say little over the last two decades has changed, except the FDA now devotes even fewer people and dollars to foreign inspections. The number of employees dedicated to the foreign inspection program is expected to fall to 102 by 2008, down from 149 in 2002. And next year, the program budget should be just shy of $16 million, or less than the $16.7 million spent in 2002, they found.

``They are in an indefensible position from a public health point of view but they have no real choice,'' said former FDA associate commissioner William Hubbard, citing the budgetary constraints faced by the agency. Hubbard has agitated for more money and inspectors at the agency and is among those expected to testify Thursday. Better technology also is needed, Hubbard said.

Congressional investigators, for example, report that the FDA maintains distinct databases covering imported drugs and their manufacturers. The import data contain largely invoice information and don't reflect how an imported drug was made, processed, packed or distributed.

``FDA has different and incompatible databases for tracking what drugs and drug ingredients are imported into the United States, what companies are certified to import drugs into the United States and which foreign drug producing firms have been inspected by the FDA,'' said Rep. Bart Stupak, D-Mich., chairman of the subcommittee holding Thursday's hearing.

Stupak said that system leaves the FDA unable to answer even basic questions about the source of foreign drug imports.