Statement by Robert Restuccia, Executive Director of Community Catalyst on the Pew Health Group’s “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs” white paper released today.

(BOSTON) – “Consumers should be alarmed by the increasingly complex, globalized, and outsourced drug supply chain described in the Pew Health Group’s After Heparin white paper.

“Americans are increasingly more reliant on medicine to keep us healthy and fight illness, and most of us take for granted that the drugs we purchase at our local pharmacy are manufactured safely. Unfortunately, we cannot rest that easy. Americans currently are not adequately protected from the risks of unsafe drugs, particularly those manufactured overseas, which account for nearly half of the drugs we consume.

“After Heparin shows that outsourcing is growing and is a business strategy for all types of prescription and over-the-counter drug producers.  As one major brand-name drug maker put it: ‘If we can buy it cheaper than we can make it then of course that’s what we’re going to do.’

“Many countries that play a significant role in manufacturing active ingredients of drugs sold in the U.S., including China and India, have weak or uneven regulatory oversight of suppliers. This affects their own citizens’ safety and ours. And without more authority and resources, FDA cannot guarantee the safety of those imports either. In contrast with U.S. manufacturing facilities, which are inspected every two to three years, the FDA currently inspects foreign facilities once every nine years.

“This new globalized and fractured system of manufacturing has significantly increased the potential for counterfeit and substandard drugs to enter our medicine cabinets and harm people. Indeed, the report shows that evidence of harm abounds.  Heparin, a blood thinner adulterated during its manufacture in China, led to dozens of serious patient reactions, including death, in the U.S.  Other serious incidents – counterfeit vials of anemia drug Epogen, stolen vials of insulin, toxic syrup in cough medicine and falsely labeled antibiotics – underscore the risks of unsafe drugs.

“The fact that the adulterated drugs made their way into the U.S. undetected has exposed a major, troubling gap in our drug safety system, and industry and government must both play a role in closing the chasm. After Heparin outlines a number of recommendations that policy makers should act swiftly to adopt. 

  • Pharmaceutical companies must have comprehensive systems to ensure the quality and safety of all our drugs-brand name, generic and over-the-counter alike. They must be held accountable for all the contractors and suppliers involved in the manufacture of drugs, update internal quality control systems that will detect and eliminate problems, implement rigorous testing standards, audit suppliers and hold company management accountable.
  • Our drug distribution system must be made secure. Prescription and over-the-counter drugs may pass through many hands before reaching patients, providing too many opportunities for the introduction of stolen or counterfeit products. Congress must improve drug distribution security through a federal serialization and verification system, while strengthening distributor and wholesaler regulation and oversight.
  • FDA needs greater authority and enforcement power. FDA should be given more resources to bring the frequency of foreign inspections in line with domestic ones. The FDA should also be granted authorities it currently lacks, such as mandatory recall, subpoena power to investigate risks quickly, and the ability to seize and destroy risky drugs at the border.

“Americans should be able to rest at night with the confidence that the drugs we take to improve our health are manufactured safely, at home or abroad. We can’t wait for another tragedy to occur before taking action. Congress and the President should make passage of drug safety legislation to address the concerns detailed in After Heparin a top priority this session.”

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About Community Catalyst
Community Catalyst is a national non-profit consumer advocacy organization dedicated to quality affordable health care for all. Community Catalyst works in partnership with national, state and local consumer organizations, policymakers, and foundations, providing leadership and support to change the health care system so it serves everyone – especially vulnerable members of society. For more information, visit www.communitycatalyst.org. Read or comment on our blogs at http://blog.communitycatalyst.org/ and http://postscript.communitycatalyst.org/. Follow us on Twitter @saferxwatch and @healthpolicyhub.