After Heparin: - The Pew Charitable Trusts

—Chapter 1—
For drug specifications that are not publicly shared, the responsibility of developing robust testing systems
lies with the manufacturer, and all companies must take steps to predict and respond to the risk of
adulteration. For public standards, USP asserts that remedying its backlog of outdated drug monographs
will require better participation from industry and the FDA. 322 The agency is working with USP to revise
outdated USP-NF monographs. 323 Because of their public nature, consideration should also be given to
using multiple tests to make a standard harder to fool. The FDA and USP revised the monograph for
heparin in 2008 to include new tests, 324 and that monograph continues to be revised in collaboration
with the international community. 325
Testing alone is not sufficient to ensure product safety, but it is a critical element of an effective
quality system. 326
1.5 Pew conference and policy
recommendations
Many of the active ingredients in the drugs that U.S. consumers take are made abroad, but there is insufficient
oversight by the FDA and foreign authorities of materials made overseas for use in U.S. drugs.
With extensive outsourcing and increased reliance on foreign suppliers, manufacturers may have less
knowledge and control over production supply chains. These weaknesses are especially alarming in light
of the risk of deliberate ingredient adulteration for profit.
To ensure the safety of the globalized pharmaceutical industry, companies must ensure greater control
of manufacturing quality, both internally and with their suppliers. Companies sourcing pharmaceutical
active ingredients and intermediates from emerging economies such as India and China have a responsibility
to ensure that these drug components are safe and are made under appropriate conditions. These
companies also must address proactively, to the greatest extent possible, the risk of economically motivated
adulteration during stages of manufacturing.
Modern quality systems, including supplier management and risk assessment, must be required to
ensure drug safety and address gaps in the FDA’s cGMP requirements. Testing methods and standards
must be continually reevaluated and updated to help protect against contamination and intentional
adulteration.
On March 14 and 15, 2011, the Pew Health Group convened a roundtable meeting of key stakeholders
to discuss concerns over safety of the U.S. drug supply and consider potential policy responses. Participants
included representatives of the FDA, USP, state regulators, major pharmaceutical manufacturing
and distribution trade associations, pharmacy organizations and medical professional groups, and
academic and consumer organizations (see Appendix B for a complete list of participants).
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Pew Health Group