Safety of Drug Imports Questioned

Some in Congress Want FDA to Expand Overseas Inspections

With an ever-larger percentage of prescription drugs and drug ingredients coming to the U.S. market from developing nations such as China and India, Congress is voicing concern that the number of inspections of those plants by the Food and Drug Administration has grown far more slowly.

In a Feb. 1 letter to the FDA, Sen. Charles E. Grassley (R-Iowa) said that the small number of inspections in these newer markets is putting consumers at risk.

In particular, he wrote, he was concerned that the number of inspections in China -- a major supplier of active drug ingredients -- is small and actually dropped from 18 in 2004 to 11 in 2007. China is believed to have hundreds, if not thousands, of plants that make ingredients for drugs headed to the United States.

"I found these numbers very troubling," Grassley wrote. "Since the beginning of FY 2002, the FDA conducted approximately 1,379 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns."

Other lawmakers and outside experts are worried that drugs from low-cost producers in India, China and elsewhere are not receiving the FDA scrutiny they require. Grassley's staff asked the FDA last year if it is planning to open an office in India.

In December, the agency said it was considering a new office only in China. Last month, however, FDA Commissioner Andrew C. von Eschenbach told reporters that he was working on a plan to station inspectors in six regions abroad so they can inspect plants on an "ongoing and continuous basis rather than episodic and periodic."

According to the statistics provided to Grassley, even that kind of inspection does not happen very often. And an overwhelming number of inspections are conducted in nations such as Germany, Switzerland, Italy and Canada rather than in countries with much weaker drug inspection programs of their own.

This is largely because the FDA can allocate "user fees" provided by brand-name drug companies to pay for inspections of their plants, many of which are in Europe. The agency does not have nearly as much money to pay for inspections for low-cost generic drugs because those manufacturers do not pay such fees.

Grassley said in his letter that "this seems to be a misplacement of limited FDA resources."

The FDA says that consumers still can be confident in the quality of the drugs they take. The agency says it has required improvements in the entire drug manufacturing process and does not rely entirely on inspections.

Responding to an October letter from Grassley's staff, Stephen R. Mason, the FDA's acting commissioner for legislation, said it cost the agency $6.2 million in fiscal 2007 to pay for about 300 foreign drug inspections.

The Bush administration has proposed a budget increase of 5.7 percent for the FDA, with additional money for foreign inspections, especially of food.

But critics said those funds will barely keep up with scheduled pay raises. A panel of outside experts told Congress last fall that the agency needs to double its budget if it hopes to keep drugs and food for Americans safe.

The Government Accountability Office reported last year that the FDA does not know how many foreign plants are manufacturing products for the American drug market, and is unaware whether they are being inspected effectively.

In response, Sens. Byron L. Dorgan (D-N.D.) and Olympia J. Snowe (R-Maine) sent letters to the heads of 10 major drug companies asking them for information on how many of their products are manufactured abroad, and where. Dorgan spokesman Barry Piatt said that nine of the 10 companies have sent in responses.