Last week, in a warning letter and press release, the FDA went to great lengths to demonize what appears to be an exceedingly safe personal prescription drug importation program offered by a Canadian company called CanaRx Services, Inc. I believe the agency crossed the line with bad advice to patients. In a nutshell, about 500 U.S. cities, companies, and other organizations use CanaRx to offer their employees and retirees a lower-cost international pharmacy option. The prescription medicines are mailed from licensed pharmacies in Canada, Australia and the United Kingdom to U.S. consumers. CanaRx’s programs have been in effect for almost 20 years and helped taxpayers and patients save $250 million, according to the company.(more…)Tagged with: CanaRx, kaiser health news, misbranded, Scott Gottlieb
Former U.S. FDA Commissioner Says 29 Countries Have Pharmaceutical Regulatory Systems Comparable to U.S.
Something unexpected happened at a dog and pony show staged at the National Press Club on April 4, where the Partnership for Safe Medicines (PSM) gave its campaign against prescription drug importation and international online pharmacies the imprimatur of technocratic expertise. Former FDA Commissioner Dr. Andrew Von Eschenbach, in opposing importation as unsafe, and “frightening” said that 29 countries have regulatory systems for drug safety comparable to the U.S. Was that a mistake? No. We need to get that list of 29 countries and create standards for distribution and refine guidance for consumers to help more Americans import lower cost medications from those countries.
I derived the number 29 because Dr. Eschenbach said: “of the 96 countries around the world that can supply drugs only 30% have a functional regulatory infrastructure that’s comparable to the one that we have at the Food and Drug Administration.” Simple math showed 30% of 96 is 28.8. I rounded to 29!
Granted, Dr. Eschenbach would say that I was taking his words out of context. (more…)Tagged with: Eschenbach, kaiser health news, Partnership for Safe Medicines, pharmaceutical regulations