Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”

Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured in China. An investigation found that batches of heparin manufactured in Baxter International’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but cause adverse reactions and even death.

Years ago most drugs were manufactured in the U.S., but over the years those operations have moved overseas – in particular, to Asia – where labor, construction, regulatory and environmental costs are lower. The FDA also inspects domestic plants far more often than foreign ones, which also adds to pharmaceutical companies’ production costs.

Following the heparin contamination last year, the FDA admitted that it was not sufficiently staffed to inspect all foreign offices. Thus, the agency has since begun to set up offices in foreign countries. To date, offices have been placed in China and India. The FDA also launched a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S.

This entry was posted on Friday, January 23rd, 2009 at 8:00 am and is filed under Heparin recall, News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.