Tuesday, December 30, 2014

The FDA and Pharmaceuticals: False Sense of Security

Consumers conduct business in a global marketplace but, unlike most world citizens, Americans outside the state of Maine do not have the right to import pharmaceutical products for medical necessities. Although the government rarely prosecutes those purchasing from foreign suppliers, the policy restricts choice and is a form of intimidation. The government's rationale for banning out-of-country manufactured drugs is safety.

The patient protection claim is absurd for more than 80% of the active ingredients in U.S. drugs have been formulated in foreign, primarily Indian/Chinese, venues. Often these businesses are owned by American pharmaceutical companies who have found significant savings by using foreign labor. Most products, food/clothing etc. imported into the U.S. indicate country of origin. Pharmaceuticals products do not provide this advice.

According to the General Accounting Office, global pharmaceutical production sites are rarely, if ever, checked by U.S. regulators:
FDA’s foreign inspection program continues to be driven by new drug applications and the agency acknowledges that it may never inspect most foreign manufacturers exporting pharmaceutical products to the United States. (GAO 1998 Report: "FDA: Improvements Needed in Foreign Drug Inspection Program" pg. 33)
In 2011 the GOA found the same FDA inspection deficiencies.

The government knew or should have known that these infrequent inspection regimens would be the cause of nightmarish patient outcomes. Two notable examples are the contaminated heparin drug imported by Baxter in 2008 and the other is the 2012 New England Compounding polluted methylprednisolone acetate product.

In both instances deviant manufacturing practices and perfunctory regulations caused death and injury to hundreds of patients. As noted by the General Accounting Office Congress's failure to allocate adequate funding for regular inspections poses needless risks to consumers. To ensure product safety, foreign and domestic facilities should receive annual unannounced visits by the FDA and no pharmaceutical product should enter the US market without said inspection.

As long as pharmaceutical prices were reasonable, most Americans did not question the legitimacy of the federal foreign drug prohibition but the costs of drugs, especially generics has risen inexplicably in the last two years. In some cases over 500% report congressional researchers. For information on savings from foreign distributors please visit PharmacyChecker.com.

Last year, in violation of federal law, the Maine legislature decided to provide state residents with an option—Mainers can legally purchase pharmaceuticals from Canada, Great Britain, Australia and New Zealand. The Maine Drug Importation Law provides consumers with choice and savings. The state of Maine is being sued by PhRMA and other interested parties who claim unfair business practices among other issues.

In early December Bloomberg News published a timely article on foreign drug imports. It is titled " Drug Batch Tainted? Just Hit Delete and Ship It to the U.S ."

Contrary to the FDA's opinion, it makes little difference where Americans purchase their prescriptions.

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