FDA Lacks Resources To Inspect Foreign Prescription Drug Manufacturing Facilities, Agency Officials Say
FDA officials do not have adequate resources to conduct required inspections of foreign manufacturing facilities that produce medications imported to the United States, agency officials said in a statement issued in response to questions raised by CongressDaily.
About 40% of prescription drugs sold in the United States are manufactured in other nations. FDA must inspect areas of foreign manufacturing facilities that produce prescription drugs sold in the United States, CongressDaily reports.
According to the FDA statement, "We are supposed to inspect each foreign drug manufacturer at least every other year, but do not achieve that goal, due to limited resources. We have only about $50 (million) to do all drug inspections each year, both domestic and foreign, so we do not get to every firm every other year, although we do inspect every firm before a new drug is allowed on the market."
The FDA statement also said that the agency could not afford "to inspect foreign pharmacies in the way contemplated" under legislation that would allow the reimportation of prescription drugs from other nations. According to CongressDaily, the FDA statement likely will "factor into the debate on both sides of the contentious reimportation issue," which lawmakers have promised to address in the next congressional session.
FDA Associate of Policy and Planning Commissioner William Hubbard said, "We can't be sure any drug we don't examine and check is safe and good. The problem with the Canadian stuff is that it hasn't gone through FDA reviews and supervision."
Some supporters of reimportation have said that the safety issues cited by FDA are "merely a smokescreen from drugmakers who fear their profits will be undercut by lower prices from Canada," CongressDaily reports. Pfizer official Peter Rost has said, "FDA has failed to keep our drug supply safe from criminals and corporate profiteers. The FDA has failed to protect the American consumer" (Rich, CongressDaily, 12/14).