HomeFeaturesDailyBriefingsRapidReconSpecial ReportsAbout Us

The "Heparin" Problem

At this point, the FDA is maintaining its position that "we do not know whether the introduction was accidental or whether it was deliberate." There is the real possibility that the contamination of the Baxter International version of Heparin from its Chinese suppliers is inadvertant or coincidental. It may very well be. Even if it is, the lackness of FDA inspection of the Chinese pharmaceutical industry as recently described in my post, Substandard Rx Reaches the U.S. from China - FDA Lacks Resources remains an equally real problem.

Prices for prescription medicines continue to rise. Many Americans are faced with choice between taking their medications or seeking lower cost alternatives through imported alternatives or Rx products purchased over the Internet. The "scare" over the contaminated product has now spread to Germany and Japan. The health and welfare of our Nation's patients depends on the confidence they have on the quality and efficacy of the products they buy. That alone implies a need for the United States and the FDA to more tightly control and inspect pharmaceutical products entering the country. Now is a good moment to repeat a quote that I've used before and will continue to do so in the future.

Gerry Norris of the Pharmaceutical Research and Manufacturers of America said: "Counterfeiters are the lowlife of bio-terrorism."

Sadly, but truly, the problem of counterfeit or contaminated medications remains one of the greatest threats to our Nation's citizens. It isn't getting better despite the FDA's Counterfeit Drug Initiative (my opinion) that started in 2003. Admittedly, the Rx industry has begun to adopt the "suggested" approach of RFID tags for tracking and tracing product through the supply chain. That alone does not acceptably address the counterfeit or contamination problem. We remain a Nation at risk.