Will the FDA ‘farm out’ its responsibility to monitor the safety of imported pharmaceutical ingredients

(From news wire sources): U.S. health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar program to inspect foreign-made medical devices has largely floundered….On Monday, U.S. Food and Drug Administration Commissioner Andrew von Eschenbach requested an extra $275 million for the agency's 2009 budget, in part to allow quicker entry for imports certified by private parties. He also called on Congress to allow the FDA to more broadly use inspections done by independent, third parties.
The Bush Administration is continuing its push for privatization of another governmental responsibility. This time it’s the support of funding ‘private inspectors’ outside the FDA system to monitor the safety of imported pharmaceutical ingredients.
Ironically, the plan is presented as a ‘solution’ to the problems of the pharmaceutical industry to adequately meet its obligations to ensure the safety and efficacy of ingredients used in the manufacture of its products.
The ‘privatization’ of the FDA responsibilities to make sure pharma meets its obligations seems to be designed to relieve the pharmaceutical industry from the consequences of its failure. And, even more ironically, this is a ‘bail-out’ of an industry that has waged a vicious campaign against access to safe, affordable prescription medicines from licensed, registered pharmacies outside the United States on the grounds that there could be no guarantee of the ‘safety’ of the medicines being sold, nor the legitimacy of the pharmacies supplying the products even though they were subject to oversight and regulations that met and even exceeded those of the U.S.
Added to this is the fact that many of the Internet-based pharmacies and Pharmacy Benefit Managers had taken extraordinary steps to provide additional inspections, protections and quality controls, all with the goal of even greater safety.
The pharmaceutical industry and its mouthpiece group PhRma was well aware of this. Yet, all the while that it was deliberately lowering its standards or turning to cheaper materials thereby endangering the lives of countless Americans, all in the name of reducing costs (but not passing along the savings to the American consumer), it continued its attacks on legitimate professional businesses that offer real price relief for Americans with no sacrifice in safety or efficacy.
Senator Bernie Sanders (I-VT) has always said: “Show me the dead Canadians” when responding to the claims of pharma about ‘bogus pharmacies’ or ‘counterfeit drugs.’
The actions of pharma reflect what has really been bogus—the hypocracy of an industry reaping excessive profits, neglecting the safety of Americans and then claiming that it is protecting Americans by continuing to restrict the ability of U.S. citizens to enjoy the health benefits of affordable medicines.
Hopefully, there is a new appreciation of the facts among policy-makers. Senator Sherod Brown (D-OH) has taken a bold step—a long-overdue one, suggesting that it might be time for an investigation of the practice of pharma to admit that it turned away from its responsibilities to the American public, but used the ‘Tar Baby’ technique of attacking legitimate licensed pharmacies .

It is time for the public and policy makers to join Senator Brown in demanding answers to a number of questions. That includes those in the media, and organizations and others who have failed to meet basic standards of truthfulness and engaged in unwarranted attacks upon businesses and organizations that have worked so hard to provide a solution to problems caused by the predatory pricing of pharma. They should be called out.
Finally, it is time for the FDA to answer a basic question: If it can support privatization or faming out its duties to inspect and monitor pharmaceutical ingredients, why then can it not consider the proven success of the monitoring and oversight of those companies that have demonstrated the safety and efficacy of prescription medicines with programs that they and others have implemented? Such action can provide the basis for helping the public in determining what is bogus and what is not by empowering citizens with knowledge, not sensational or ill-founded charges.