The special health issue of The Hill has a prescription for ensuring U.S. drug safety.  This op-ed on why Congress must end the inspection disparity between U.S. pharmaceutical plants and foreign drug makers is a must-read for every lawmaker and the consumers of the 4 billion prescriptions filled last year.

Every day, millions of Americans take medicines approved by the U.S. Food and Drug Administration (FDA), bearing the name of some of our nation’s best-known pharmaceutical companies, and prescribed by health care providers. Yet, what most Americans don’t know is that, for most of these drugs, their components were manufactured in facilities that may have never been inspected by a government agency. “In fact, according to a U.S. Government Accountability Office (GAO) report, at least 80 percent of the ingredients in U.S. drugs now originate overseas.  And this could be real cause for concern,” according to the article’s authors, Patricia Benson and Allan Coukell.

The migration of pharmaceutical manufacturing to low-cost countries with low regulatory oversight, such as India and China, may promote counterfeiting, adulteration or other corner-cutting failures to meet quality standards.  This scenario occurred with the adulteration of heparin in 2007. The results were devastating as Benson and Coukell noted: “The FDA would eventually receive reports of 574 Americans who suffered symptoms associated with this tainted medicine, some of whom died, over a three month period in early 2008 – a clear breach of the U.S. supply chain.”

Two key lessons that should be learned from heparin are spotlighted in The Hill piece:

  • First, Baxter did not conduct its own audit of the Chinese supplier until three years after they began contracting with this firm. U.S. drug makers must be held accountable for the contractors they choose. They must demand that their foreign suppliers meet the FDA’s rigorous standards— even if it means conducting a meaningful investigation before adding contractors’ goods to a pharmaceutical supply chain.
  • Second, the FDA approved the Chinese supplier of heparin without conducting a pre-approval inspection in part because the contractor had a name similar to another supplier in the agency’s database. This example, and others like it, indicates that to provide ongoing oversight of the industries and technologies it regulates, the FDA must modernize old and error-prone databases. In addition, the FDA needs to conduct more inspections of foreign plants that supply drugs and pharmaceutical ingredients for U.S. use. Unfortunately, the agency lacks the resources to visit overseas manufacturing sites with any meaningful regularity.
Now the question is whether Congress is listening.

— Marcia Hams, Community Catalyst Director of Prescription Access and Quality