By Daniel R. Matlis
Today, 80 percent of the active pharmaceutical ingredients and bulk chemicals used to make U.S. drugs originate outside of this country. Increased outsourcing of manufacturing, a complex and globalized supply chain, and criminal actors create the potential for counterfeit or substandard medicines to reach patients. “Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers. Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe,” said Allan Coukell, director of medical programs at the Pew Health Group.
To examine today’s pharmaceutical supply chain and its risks, the Pew Health Group produced a white paper entitled After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. The report takes a comprehensive look looks holistically at the production and distribution of drugs from the sourcing of raw materials to the pharmacy counter.
After Heparin is based on public information, including FDA documents, U.S. Government Accountability Office (GAO) reports, congressional testimony, peer-reviewed journals and interviews with more than 50 supply chain experts and stakeholders. The initial findings and recommendations were discussed during a two-day March convening in that included a diverse group of industry representatives, ranging from ingredient manufacturers to community pharmacists. (The Pew Health Group whitepaper references Axendia’s Report “Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences.”)
“Today’s prescriptions are being produced under last century’s oversight,” said Allan Coukell, director of medical programs at the Pew Health Group. “As pharmaceutical manufacturing is increasingly globalized and outsourced, Congress must close serious gaps in FDA oversight. In particular, the agency must be able to order the recall of adulterated drugs — a power now lacking — and must have the ability to block medicines from entering the U.S. if they were made at a factory that refused an FDA inspection. At the same time, manufacturers should bear ultimate responsibility for drug safety. Congress should require companies purchasing pharmaceutical ingredients from overseas to ensure that their suppliers are manufacturing to the highest standards.”
The Pew Health Group White paper details a number of recommendations for industry and 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 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 stronger national standards for the 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 substandard drug, similar to the agency’s authority for food and medical devices. In addition, the agency needs the authority to subpoena documents and witnesses and an improved set of enforcement tools, such as strengthened penalties for certain violations.
“The After Heparin white paper identifies links in the supply chain that government and business should strengthen” Coukell added.