Recent incidents of counterfeit products infiltrating the drug distribution system represent a growing public health threat, which is putting patients at risk every day in this country.
Today’s pharmaceutical distribution supply chain is governed largely by a patchwork of state laws and regulations that allows criminals to enter markets with the lowest safety requirements to inject counterfeit, unsafe, and potentially lethal products into the national supply chain. The state-by-state system is both onerous and ineffective, and the risk it poses to public health from counterfeiters can no longer be ignored.
The Food and Drug Administration is investigating a rising number of cases involving counterfeit prescription drugs — cases that threaten the health of individual patients and the safety of the nation’s drug supply. The FDA’s Office of Criminal Investigation opened 72 new cases in 2010, up from just six a decade earlier. Federal officials document that American consumers have purchased counterfeit Adderall, Vicodin, Viagra, Xanax, flu medications and even cancer drugs.
Congress must establish a federal tracking system to protect consumers from illicit, counterfeit and possibly deadly drugs. A single, uniform national solution is needed to best protect consumers and patients across the country. A strong, national tracking system prevents the introduction of significant inefficiencies and confusion that come with a maze of contradictory laws that bad actors may seize upon. Patients, physicians and other affected stakeholders all have a vested interest in making sure that patients are getting products as prescribed.
The good news is that leading members of the House and Senate have introduced and passed bipartisan legislation to establish a federal traceability system. The House legislation (H.R. 1919) passed the House by a voice vote on June 3, while the Senate legislation (S. 957) passed the Senate Health, Education, Labor and Pensions Committee unanimously on May 24 and now awaits floor action. Both of these bills would increase the security and safety of the drug supply chain by establishing nationwide standards.
This solution would also strengthen the ability of the FDA to keep bad actors out of the system. Most importantly, the legislation would protect patients and consumers today while being enhanced in a stepwise manner as additional technologies are developed over time.
Compliance with a federally established standard will be costly initially to our companies and the other affected stakeholders in the supply chain, but it is necessary to protect patient safety.
In the long run, by freeing the industry to meet a single set of requirements rather than the regulatory developments of 50 individual states, both consumers and companies would save money in the long run.
The time is now to enact a national pharmaceutical distribution supply chain solution. All of the key stakeholders in the supply chain remain strongly committed to a national solution, and the concept of a national solution continues to enjoy strong bipartisan support in Congress.
Jim Greenwood is president and CEO of BIO, which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations.