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Addressing Lack Of FDA Inspections Of Foreign Prescription Drugs

Armen Hareyan's picture

The House Energy and Commerce Oversight and Investigations Subcommittee on Thursday will hold a hearing to address a recent decrease in FDAinspections of foreign companies that manufacture medications andmedication ingredients despite an increase in volume of imports of suchproducts, the Washington Post reports.

Accordingto congressional investigators, FDA inspects foreign companies onceevery eight to 12 years, compared with at least once every two yearsfor U.S. companies. In addition, congressional investigators found thatFDA officials use interpreters supplied by foreign companies, ratherthan supplied by the agency, to conduct inspections and must informforeign companies of inspections in advance.

FDA spent $16.7million on inspections of foreign companies in 2002 and will spend anestimated $16 million in 2008, although the volume of imports ofmedications and medication ingredients doubles every five years,congressional investigators found (Kaufman, Washington Post,11/1). The U.S. imports medications and medication ingredients from anestimated 3,000 to 6,700 foreign companies, according to congressionalinvestigators.

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Committee Chair JohnDingell (D-Mich.) said, "Given the potential risk from foreign sources,this places an unacceptable risk on the public" (Bridges, AP/Washington Post,11/1). He added, "China alone has more than 700 firms making drugproducts for the U.S., yet the FDA has resources to conduct only about20 inspections a year in China. This is dangerously inadequate" (Washington Post, 11/1).

SubcommitteeChair Bart Stupak (D-Mich.) said, "FDA has different and incompatibledatabases for tracking what drugs and drug ingredients are importedinto the United States, what companies are certified to import drugsinto the United States and which foreign drug producing firms have beeninspected by the FDA."

According to former FDA AssociateCommissioner William Hubbard, who will testify at the hearing,budgetary issues, as well as technological issues, limit the ability ofFDA to inspect foreign companies that manufacture medications andmedication ingredients. He said, "They are in an indefensible positionfrom a public health point of view, but they have no real choice." FDACommissioner Andrew von Eschenbach, who also will testify at thehearing, declined to comment (AP/Washington Post, 11/1).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily HealthPolicy Report is published for kaisernetwork.org, a free service of The HenryJ. Kaiser Family Foundation.