Wednesday, March 05, 2008

The Push for Imported Drugs

There was a bit of a dust-up in the prescription drug industry a few years ago: because of the high cost of many drugs in the United States, many seniors and others with high pharmacy costs were physically purchasing the same drugs in Canada or Mexico and taking them home with them. Then the obvious follow-up was: Why not just have the pharmacy mail them to you? And the answer was it was illegal under current US law. Then the drug industry in a major campaign said imported drugs wouldn't be safe because they weren't under FDA supervision, despite the fact that many of the drugs in the US were actually made in these same factories and imported by the drug makers. And various attempts to legalize importation from certain countries were tabled.

The FDA said in 2002

Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices.

As part of the FDA's high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.

After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. "With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements," McCallion says.

Now, we learn that heparin manufactured by Baxter is actually created with pigs from China with incredibly questionable processes--buying random pig's intestines from unknown city farms. Over a dozen deaths, and potentially 400 serious reactions have been linked to the failure of the FDA and the drug industry to maintain quality control.

Is this the quality we were supposed to get from a forced domestic drug industry? Is this what happens with a neutered federal watchdog administration?

No comments: