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Pew finds serious gaps in oversight of US drug safety
Date:7/11/2011

overnment Accountability Office (GAO) reports, congressional testimony, peer-reviewed journals and interviews with more than 50 supply chain experts and stakeholders. The findings and recommendations were discussed during a recent two-day convening on the white paper that included a diverse group of industry representatives, ranging from ingredient manufacturers to community pharmacists.

After Heparin details a number of recommendations for policy makers to remedy drug supply chain problems, including:

  • Pharmaceutical companies must have comprehensive systems to ensure quality and safety. This means that companies must take responsibility for the entire supply chain by: improving oversight of contract manufacturers and suppliers; ensuring documentation and transparency of incoming drug ingredients and; developing rigorous testing standards. Drug makers must audit suppliers on-site prior to engagement and institute supplier quality agreements. Company management must be held accountable for implementing these systems.

  • The security of drug distribution must be improved. Once manufacturing is complete, medicines may pass through many hands before reaching patients, providing opportunities for stolen or counterfeit products to enter the system. Insufficient tracking and transparency can prevent industry and regulators from identifying the source of stolen or counterfeit products. Congress should establish national standards and oversight of drug wholesalers and require the private sector to track and verify the authenticity of pharmaceuticals.

  • FDA authority and enforcement gaps must be addressed. Despite globalization of manufacturing, U.S. government oversight is largely domestically focused. Overseas inspections by the agency must be significantly increased, along with expanded use of third-party sources of information to supplement FDA inspections. Congress should ensure that FDA can order the recall of an adulterated or subs
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Contact: Linda Paris
lparis@pewtrusts.org
202-540-6354
Pew Health Group
Source:Eurekalert

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