After Heparin: - The Pew Charitable Trusts

Executive Summary
and 15, 2011, in Washington, D.C. Conference participants included leadership from the FDA, the United
States Pharmacopeial Convention (USP), major pharmaceutical manufacturing and distribution trade
associations, pharmacy organizations and medical professional groups, individual supply chain experts
and consumer organizations. This paper has now been revised to incorporate outcomes and stakeholder
discussion from that meeting.
This report concludes that more can—and must—be done to ensure the safety of “upstream” pharmaceutical
manufacturing (chapter 1), to provide the FDA with essential authorities and resources to
exercise effective oversight (chapter 2) and to improve the security of “downstream” pharmaceutical
distribution (chapter 3).
In a world where drug manufacturing is increasingly outsourced and offshored, robust supply chain
management is critical. Pharmaceutical companies have the ultimate responsibility for drug quality and
safety, but some companies may not be adequately verifying the quality of their suppliers. 11,12 Ensuring
drug-ingredient manufacturers meet quality standards is critical to ensuring the quality of the product
itself. However, chapter 1 reviews numerous situations in which foreign producers and traders have
misrepresented the source drug ingredients from the United States and other purchasers, in some cases
concealing substandard products that harmed consumers. It is essential that manufacturers look beyond
current manufacturing quality standards (known as good manufacturing practices, or GMPs) in their
own facilities to ensure appropriate supplier qualification, through risk-based assessments, quality agreements
and physical audits, where appropriate.
The FDA and its counterpart agencies worldwide monitor the quality and safety of drug manufacturing
by inspecting plants and validating compliance with GMPs. However, the FDA lacks the resources,
capacity and authority to effectively inspect foreign facilities and assess risk. 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 on average. 13 Improved oversight of foreign manufacturing is essential
and will require increased resources for the FDA, some of which could be obtained through industry
fees. In addition, the agency will have to make additional use of third-party inspections, including those
by other regulators and, potentially, private entities. The FDA also requires certain new authorities to enable
effective oversight and must more effectively use its existing authorities and resources. The agency
should have the power to mandate recalls, subpoena witnesses and documents and destroy at the border
any products that present public safety risks. In the long term, ameliorating risks to the U.S. and global
drug supply requires international cooperation, harmonization of standards and steps to improve the
capacity of regulatory bodies in the developing countries where manufacturing increasingly takes place.
The movement of finished drugs from manufacturer to the consumer is also a complex process involving
many intermediate players. The past decade has seen several instances of adulterated and counterfeit
drugs infiltrating U.S. distribution. In 2002, counterfeit vials of the anemia drug Epogen ® entered the
distribution supply chain through licensed wholesalers and were sold by U.S. pharmacies. 14–16 A shipment
of 129,000 vials of insulin, stolen in June 2009, was stored under unknown conditions before
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Pew Health Group