During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.” Referring to the heparin-contamination case as a “wake-up call” to supply-chain risks, Allan Coukell, Pew’s director of medical programs, said that while the vast majority of drugs are not counterfeit, there are real risks. Overcoming those risks will require the pharmaceutical industry to take action, suggested panelists speaking during the forum.
Panelists included Deborah Autor, Esq., director, Office of Compliance, the Center for Drug Evaluation and Research, U.S. FDA; Heather Bresch, president, Mylan, a global generics and specialty pharmaceutical company; and John Gray, president and CEO, Healthcare Distribution Management Association (HDMA), which represents U.S. pharmaceutical distributors.
FDA’s Autor stated that prescription pharmaceuticals follow complex paths through multistep supply chains before reaching U.S. patients, and at every step they face potential vulnerabilities. The heparin case in particular enabled FDA to identify “very significant gaps in the system that need to be addressed,” Autor said. “The challenge now is to work hard to prevent future tragedies and minimize risks.”
“Heparin was a crime of opportunity, and our challenge is to reduce the opportunities for crime,” Autor said.
However, “workload has outstripped FDA’s resources,” Autor added. “FDA’s law is antiquated,” she said, adding that FDA lacks complete enforcement authority.
“While FDA has not taken a position on any legislation, new regulatory authority could help ensure that we can hold industry accountable for security and integrity of their supply chains and ensuring that their quality control systems are adequate,” she said. A system could be put in place in which manufacturers “are held accountable for managing their supply chains and suppliers” along with “track and trace to make sure we are able to follow products through the supply chain,” Autor added.
More than legislation is needed, however. Bresch, president of Mylan, who described an “unlevel playing field” in terms of FDA inspections around the world, called for support of additional fees to “provide FDA with resources needed for globalization.”
Standardized identification systems are needed, too. To improve patient safety and supply chain efficiency, HDMA president Gray said that HDMA “supports federal legislation to establish a uniform national requirement to replace conflicting or additional state pedigree requirements with a primary distribution model until standards and technology solutions are reasonably available for cost-effective electronic methods.”
HDMA “supports serialization of prescription drugs at the unit, case, and pallet levels along with a robust and standardized data exchange system,” Gray said.
In its report, Pew makes several policy recommendations that appear to echo those of the panelists. For instance, Pew states that “companies should establish procedures to identify, monitor, and evaluate risk factors that could impact product quality, safety, strength, purity, and identity.”
Pew also states that “each drug package” should be required “to bear a unique serial number” and that “drugs should be serialized at the level of the smallest container from which a drug may be repackaged or dispensed (also called a unit). Repackagers should be required to re-serialize product and link new serial numbers to original serial numbers.”
Pew’s drafted report was initially discussed at a stakeholder conference on policy reforms held on March 14 to 15 in Washington, DC, and was revised to incorporate stakeholder discussion from that meeting. The in-depth report includes a valuable history of recent supply-chain risks and crimes along with pages of references worth visiting for more details.
Gabrielle Cosel, manager of the Pew Prescription Project, today cited one of those supply-chain crimes—the stolen shipment of 129,000 vials of insulin in June 2009. “Of those 129,000 vials, only 2% were recovered,” she said. “A better system is needed to ensure authenticity,” she concluded.
I believe that manufacturers must play a role in that system and take steps ahead of any legislation. “Never will FDA be in a position to ensure the quality of everybody’s product,” said Autor. “It has to be the responsibility of manufacturers.”
“Firms must think proactively about the vulnerability of their products . . . and pay attention to market conditions that present risks,” Autor said.