House Hearing To Address Lack Of FDA Inspections Of Foreign Prescription Drugs

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Public Health
Article Date: 02 Nov 2007 - 11:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

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

According to congressional investigators, FDA inspects foreign companies once every eight to 12 years, compared with at least once every two years for U.S. companies. In addition, congressional investigators found that FDA officials use interpreters supplied by foreign companies, rather than supplied by the agency, to conduct inspections and must inform foreign companies of inspections in advance.

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

Comments
Committee Chair John Dingell (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 drug products for the U.S., yet the FDA has resources to conduct only about 20 inspections a year in China. This is dangerously inadequate" (Washington Post, 11/1).

Subcommittee Chair Bart Stupak (D-Mich.) said, "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."

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

Broadcast Coverage
CNN's "Lou Dobbs Tonight" on Thursday reported on a House panel investigation of imported prescription drugs (Dobbs, "Lou Dobbs Tonight," CNN, 11/1). A transcript will be available online Friday morning. WAMU's "The Diane Rehm Show" on Thursday reported on the safety of imported drugs. The segment includes comments from Washington Post reporter Marc Kaufman; Gilbert Ross, medical/executive director of the American Council on Science and Health; Caroline Loew, senior vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America; Sidney Wolfe, director of the Health Research Group at Public Citizen; and Senate Finance Committee ranking member Chuck Grassley (R-Iowa) (Rehm, "The Diane Rehm Show," WAMU, 11/1). Audio of the segment will be available online after the show.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.