The FDA and foreign drug ingredients

As a complete and utter layman with no medical or scientific training, I can’t help but wonder: How do cheap, counterfeit, and contaminated ingredients from small, unregulated Chinese consolidators find their way into mainstream American drugs such as Baxter’s Heparin?

In the recent Heparin case, Baxter has said that its investigators have not been able to get permission from the Chinese to visit these operations, and the FDA has not yet done inspections on any of these facilities either.

So what’s the deal with FDA-approved drugs with Chinese ingredients? Some fast facts from here, here and here:

China has an estimated 80,000 chemical companies, and the FDA doesn’t know how many sell ingredients used in drugs consumed by Americans (or on-sold from America to other countries).

An AstraZeneca exec recently acknowledged plans for outsourcing production of some of their bestselling meds in the Far East, including China.

Professor Michael Santoro, Business Ethicist from Rutgers Business School, states that currently “there are only 10 or so drugs or ingredients that are covered by the [FDA Product Safety] agreement” (in relation to foreign manufactured drugs).

According to Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research, the FDA focuses on domestic companies, with only about 10 percent of the foreign facilities shipping pharmaceuticals to the US inspected annually. (note: if that.)

In many cases, it is left up to the pharmaceutical company to inspect these foreign factories and, as in the case with Heparin, sometimes they are not granted permission by the foreign government to do so.

The FDA recently received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People’s Republic of China.

According to the FDA, the permanent overseas offices in China are being created in the hopes of allowing increased access for inspections and greater interactions with manufacturers to help ensure products shipped to the US meet US standards for safety and manufacturing quality.

These appointments are still pending authorization from the Chinese government.

In November, the Government Accountability Office found the FDA didn’t know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, some of them small unregulated family operations, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list.

The agency (FDA) also could not confirm how many foreign firms have never been inspected.

The Democrat in charge of an appropriations panel responsible for FDA funding says that this is “embarrassing,” but in true Lefty fashion, she blames George Bush, claiming that it simply demonstrates the FDA’s “myriad failures under the Bush administration.” (Wow. Wonder whether there’s any cheap and nasty imported drug to treat Bush Derangement Syndrome?)

Timing-wise, the Heparin situation was unfolding around the same time that the US Congress was holding yet another hearing into the problem of drugs in sport. Observation from a friend who was directly involved in the Heparin contamination fall-out: “It simply amazes me how Congress is full force when it comes to making sure they weed out HGH and steroids in Major League Baseball, but when it comes to Chinese-manufactured medications and ingredients killing and injuring people in the U.S. and around the world, we seem to not be so attentive.”

Maybe we need a bad batch of foreign-made HGH or steroids affecting a pro athlete to get people outraged enough to demand that something be done to stop this madness?

(see also my previous posts on this here and here.)