The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group. Increased outsourcing and the complex global supply chain create the potential for counterfeit or substandard medicines to enter the supply chain, says the white paper, titled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.” The authors recommend several steps for improving the security of the pharmaceutical supply chain.
First, the paper proposes that pharmaceutical firms establish comprehensive systems to ensure drug quality and safety. Companies should take responsibility for the entire supply chain by improving their oversight of contract manufacturers and suppliers, say the authors. Drugmakers should perform on-site supplier audits and institute supplier quality agreements, according to the white paper. Incoming materials should be inspected rigorously and be accompanied by proper documentation. Company management must be held responsible for carrying out these measures, according to the white paper.
Second, Congress should establish national standards and oversight of drug wholesalers and require private companies to track and verify the authenticity of pharmaceuticals, according to the white paper. After drugs have been manufactured, they sometimes pass through many intermediaries on their way to patients, thus creating the opportunity for products to be stolen or counterfeited, says the paper. Tracking and transparency initiatives can improve the security of drug distribution by enabling industry and regulators to identify the source of stolen or counterfeit products.
Third, FDA must increase the number of overseas inspections it performs significantly, and it must expand its use of third-party sources of information to supplement these inspections, according to the white paper. Congress must give FDA enforcement powers that it now lacks. For example, Congress should ensure that FDA can order the recall of an adulterated or substandard drug, according to the white paper. In addition, FDA should have the authority to subpoena documents and witnesses, and it should be able to impose tougher penalties for certain violations, say the authors.
“Today’s prescriptions are being produced under last century’s oversight,” said Allan Coukell, director of medical programs at the PEW Health Group, in a press release. “Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe,” he added.
The white paper describes incidents involving adulterated heparin manufactured in China, counterfeit vials of the anemia drug Epogen, and stolen vials of insulin to illustrate how substandard or adulterated pharmaceutical materials from abroad have entered the US. The document is based on FDA documents, US Government Accountability Office reports, Congressional testimony, peer-reviewed journals, and interviews with supply-chain experts. The PEW Health Group discussed its findings and recommendations with industry representatives, including ingredient manufacturers and community pharmacists. The group later revised the white paper to reflect the discussion.