FDA moves to allay drug-import fears

Just as the Fed is scrambling for new initiatives to shore up the U.S. financial system, the FDA is hustling up new programs designed to shore up confidence in drug safety--and in its own ability to ensure it. The immediate impetus, of course, is the heparin safety scandal, which happens to dovetail nicely with recent warnings that the regulatory agency isn't up to the task of overseeing a growing flood of imported drugs.

Here are the government's latest moves:

• The FDA announced Friday that all imported heparin would be stopped at the U.S. border for testing. Sophisticated molecular analysis, you'll recall, uncovered a contaminant in lots of the med linked to hundreds of serious reactions and up to 19 deaths.
• FDA officials announced they are "very close" to identifying the contaminant, which hasn't been linked conclusively to the allergic reactions, but is the prime suspect. Once they know what it is, officials can better determine whether it was added deliberately to the heparin--much as melamine was added to pet food last year--or arose because of a processing problem.
• The FDA praised the cooperation it's getting from China's drug watchdogs. Those watchdogs announced that they're "working closely" with the FDA on the heparin investigation.
• Notwithstanding its close and personal relationship with the Chinese SFDA, the agency said it would step up its presence in China with eight new "permanent FDA positions" at U.S. diplomatic posts there. Plus, five Chinese nationals will be hired to work with those new in-country FDA staffers.
• The Senate passed a resolution Friday to add $375 million to the FDA's budget, a 20 percent increase over this year's spending.

Meanwhile, the Los Angeles Times is reporting that investigators are focusing on the possibility that raw ingredients for heparin were contaminated before they ever got to the active ingredient supplier's Chinese plant. Baxter says it had tried to trace its supply chain back to the heparin's original source, i.e. the workshops where ingredients are harvested from pig intestines, but "[w]e have not been able to do so."

Chinese products have been under fire for months on end as one product after another has been found unsafe, from pet food to kids' toys to, now, drug ingredients. Not surprisingly, newspaper editorials are calling for reforms, of the FDA and of drug makers' internal quality-control processes.

- find out about the import tests [1] in the New York Times
- read about the FDA's Chinese expansion [2] in the Chicago Tribune
- see China's pledge [3] to work with the FDA from the Associated Press
- check out the FDA budget news [4] in the NYT
- get more [5] from the LA Times
- find this editorial [6] in the Chicago Tribune

ALSO: Baxter's public relations department isn't getting any favors these days. In the midst of the contamination brouhaha, the company faces a lawsuit and heavy criticism from Dennis Quaid, who went on 60 Minutes this weekend to talk about the medical error that led to his twin babies receiving an overdose of heparin. Report [7]

Related Articles:
Recalls don't put pharma off China. Report [8]
Heparin mimic found in suspect samples. Report
[9]China: Buyers on hook for drug safety. Report [10]
Americans distrust drugs from China, India. Report
[11]Overseas drugmaking goes unsupervised. Report
[12]FDA can't guarantee drug safety. Report [13]