In the Field

Dec 02, 2007
By Pharmaceutical Technology Editors
Volume 31, Issue 12


Congress Focuses on FDA Inspections of Foreign Drug Facilities

The US Food and Drug Administration's effectiveness in regulating the manufacture of pharmaceutical products and active pharmaceutical ingredients (APIs) at foreign facilities was questioned at a Congressional hearing in early November. Congress, industry, and government officials weighed in on the issue.

"Most Americans do not realize that today many of the drug products in their medicine cabinets come from overseas," said Rep. Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations in a prepared statement. The subcommittee held a hearing about FDA Commissioner Testifies Before Congress on Foreign Inspection Process foreign-inspection process that was intended to evaluate the agency's effectiveness in overseeing foreign drug production. The hearing also explored what resources the agency realistically needs to do the job.

Stupak said that more than 80% of the APIs that go into drugs come from abroad, and that India and China account for almost half of those imports. "India's pharmaceutical imports into this country have increased 2400% from 1996 to 2006, making it the fastest-growing drug importer, and China has doubled its pharmaceutical exports to the US over the last five years," he added.

Federal law requires follow-up inspections for US drug manufacturers every two years, but no law dictates how often FDA must inspect foreign drug manufacturers, said Stupak.

"From the limited data we have gleaned from the agency, FDA's foreign drug inspection program has serious shortcomings," said Stupak. These shortcomings include difficulties in accurately accessing the number of foreign drug facilities and limited resources for inspecting these facilities.

To illustrate the problem, Stupak said his committee and the Government Accountability Office (GAO) repeatedly asked FDA for the number of foreign firms the agency is supposed to be inspecting overseas and where they are located. "For three months, the FDA has on 10 different occasions provided numbers ranging from 2100 to 13,800 foreign firms....It has been nearly impossible for the committee staff to calculate what resources FDA needs because its internal data is simply in shambles," said Stupak.

GAO recently issued a report criticizing FDA's program for inspecting foreign drug manufacturing based on weaknesses in its databases.

Stupak also pointed out that FDA can only conduct 200 to 300 foreign follow-up inspections each year. If one assumes that the rough estimate of foreign drug manufacturers is 3000, a number Stupak's committee believes to be fairly accurate, FDA would only be able to inspect each foreign drug firm about every 13 years.

Stupak also questioned whether FDA allocates its inspection resources adequately. He says that China, with more than 700 drug firms, represents the largest source of production facilities that ship drug products to the United States. However, only 4% of FDA's resources for foreign inspections are allocated for facilities in China.

Stupak said that the Bush administration's solution for FDA's lack of inspection resources is to negotiate memoranda of agreements with foreign governments, but "such efforts will not overcome the lack of FDA funding for on-the-ground foreign inspections." He added that India and China are "not anywhere near being ready for such agreements" and recommended FDA open offices in parts of the world where pharmaceutical manufacturing is located.

-Patricia Van Arnum

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