After Heparin: - The Pew Charitable Trusts

PHARMACEUTICAL MANUFACTURING: GLOBALIZATION AND QUALITY MANAGEMENT
2. Require clear, strong, quality agreements for suppliers. Quality expectations should be clearly
established for, and contractually agreed to, by suppliers. Agreements should acknowledge U.S.
quality requirements and establish that, if necessary, FDA officials will have access to a supplier’s
plant. Agreements should also require suppliers and contractors to report manufacturing changes
to the purchasing company. If possible, quality agreements should be included as a part of main
supplier contracts to clearly set expectations.
3. Increase information sharing among industry to ensure supply chain safety. Industry should
share information on suppliers, risk signals, and other global market data that might help to
ensure product quality and safety. Legal barriers to information sharing should be actively addressed
through antitrust waivers, if necessary, or safe-harbor provisions in contracts.
C. Enhance documentation and transparency of the upstream manufacturing supply chain
through legal requirements.
1. Companies should know and be able to document the companies involved in their upstream
manufacturing supply chain. Drug companies must know the entities involved in the
manufacture, processing, and transportation of their drugs and active ingredients. This documentation
should be available to regulators on demand.
2. Require all drug companies to state country of origin for their drugs and active pharmaceutical
ingredients on their websites. Pharmaceuticals should not be subject to less transparency
than other consumer products. Country of origin should be listed for both the finished drug and
the drug’s active ingredients. While pharmacy dispensing may make country-of-origin labeling
on drug bottles less useful for consumers, this information could be made available to the public
through other means, such as package inserts or on a company’s website.
D. Improve testing standards
1. Industry and regulators must continually seek to develop better testing methods to ensure
the identity, purity and safety of drugs. Manufacturers must be responsible for ensuring the
purity of their drugs and drug components through robust testing methods, and should review
and update analytic methods in an ongoing manner. Regulators and industry stakeholders agree
that better methods for detecting and measuring drug contamination are needed. In addition to
improving their methods, drug companies could use multiple assays as a check against bad actors
who might try to design fake ingredients that are able to fool specific tests.
2. Require continual assessment and updating of public testing standards. Compendial testing
standards should be regularly reviewed to ensure adequacy. The FDA and USP should work together
to ensure that public standards are robust and up to date, and identify and prioritize those
assays that need to be updated and/or revised.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 43