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Originally Published PMPN July 2005
Regulatory Focus
FDA Praises Advances on Counterfeiting
Agency activities include new model rules for regulating wholesalers.
David Vaczek
Senior Editor
The drive to curtail counterfeiting is already yielding results. In an FDA report published May 18, 2005, the agency reports that states have adopted strong measures for supply chain oversight and enforcement, and industry has made strides in planning for track-and-trace technology.
FDA’s Office of Criminal Investigations launched 58 counterfeit drug cases in 2004, compared with 30 cases in 2003, according to “Combating Counterfeit Drugs: A Report of the FDA Annual Update.”
Most counterfeits found did not reach consumers, the agency said. “Although the number of counterfeit drug cases has increased and the threat to the public health is real, most of the suspected counterfeits that we discovered in 2004 were found in smaller quantities, compared with those found in 2003. Most of these drugs were destined for the black market or Internet distribution, rather than for widespread distribution in the nation’s drug supply chain,” the report said.
Since FDA’s February 2004 initial report on counterfeiting, three strategies have been completed. The instructions for use of the MedWatch form and the Web site for health professionals reporting suspected counterfeits have been clarified. The agency created the Counterfeit Alert Network (CAN). In the network, 13 organizations to date have agreed to share counterfeiting information, including timely reporting on specific counterfeit incidents. And, the agency streamlined its internal processes for rapid response to counterfeit reports.
Over the past year, the report notes, “tremendous progress” was made in development and testing of RFID/EPC technology. FDA sees RFID as the most-promising means for securing supply chain integrity, with a goal of widespread use of track-and-trace systems by 2007. As the agency launched an RFID Work Group for promoting RFID’s adoption, industry initiatives included pilot programs testing RFID across the supply chain. Three pharmaceutical companies intend to integrate RFID tags into packaging this year, the agency noted.
Even though the agency produced a Compliance Policy Guide on good manufacturing practices in labeling for companies testing RFID solutions, it held off issuing guidance on labeling and packaging procedures for applying product authentication technologies. FDA hopes to gain more experience working with companies implementing the features before offering such guidance.
The drug wholesale industry is preparing for tougher standards and stiffer penalties, another FDA goal. Since last year, at the agency’s behest, the National Association of Boards of Pharmacy revised Model Rules for states to adopt in licensing and certifying wholesalers. The revisions include “a much tighter and detailed application process” with requirements including a criminal background check, said NABP executive director Carmen Catizone. The revisions call for implementation of product tracking and documentation, initially with paper pedigrees, but evolving to RFID. In addition, they spell out tougher penalties for counterfeit drug trafficking.
NABP also created the Verified-Accredited Wholesale Distributors (VAWD) program, where NABP inspects and certifies wholesalers for licensure and best practice compliance. It provides resources and expertise for inspections that states may lack, said Catizone. Indiana became the first state to require VAWD accreditation for wholesalers doing business.
“Numerous states are reviewing their licensure regulations or laws. Arizona, Indiana, Texas, and Nevada passed legislation this year,” said Scott Melville, senior vice president, government affairs, for the Healthcare Distribution Management Association (HDMA).
HDMA issued best-practice guidelines that in most aspects mirror the NABP’s Model Rules. It implemented new membership rules mandating adoption of the best practices.
The requirements by NABP and HDMA are based on regulations enacted by Florida in 2003, in the wake of an investigation of practices that found that some of the state’s wholesalers were amateurs with criminal records.
Florida’s law requires background checks, naming of a designated representative for each facility, posting a $100,000 bond to verify financial solvency, and product pedigree tracking. It makes trafficking in illegal drugs worth more than $25,000 a first-degree felony.
In the two years since the regulations were put into effect, the number of wholesalers operating in the state has declined to 800, from over 1300, said Melville.
Copyright ©2005 Pharmaceutical & Medical Packaging News
