US FDA's New Measures to Protect Americans from Counterfeit Drugs
by Joseph X. Phillips, ISPE Regulatory Affairs Advisor
On 6 June 2006, the US Food & Drug Administration (US FDA) announced new steps to strengthen the existing protections against a growing problem of counterfeit drugs. The measures recommended by the agency’s Counterfeit Drug Task Force emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of the US drug supply.
The announcement states that the US FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products throughout the distribution system. These are the so-called “pedigree” requirements. The US FDA had placed on hold certain regulatory provisions because of potential impact on small wholesalers. In 2004, the US FDA had delayed the effective date of certain regulatory provisions regarding pedigrees to allow industry to adopt electronic technology for tracking drugs through the supply chain. Originally, the US FDA had expected this technology to be in widespread use by 2007. It appears these expectations will not be met. The US FDA has not heard that the concerns raised in the past about impact on small wholesalers remains. In fact, the US FDA was encouraged by most drug stakeholders to allow the hold to expire.
The US FDA has determined it can no longer justify not implementing these regulations, and the hold will expire in December 2006.
A potential new measure to safeguard the drug supply is the use of electronic track and trace technology, such as radio-frequency identification (RFID). This is the technology the US FDA had expected to be in widespread use by 2007.
During the next year, the US FDA’s enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion. The US FDA intends to announce in the Federal Register the availability of a draft compliance policy guide for public comment describing its enforcement approach. The US FDA, in providing the guidance on the types of drugs that are currently of the greatest concern to the US FDA, intends to give wholesale distributors a better idea of where to focus their resources to come into complete compliance with the regulations (21 CFR Part 203) for all the prescription drugs they distribute.
The US FDA may, under appropriate circumstances initiate regulatory action, including criminal prosecution, for pedigree violations that do not meet the factors listed in the guidance.
The Task Force emphasized the agency’s belief that widespread use of e-pedigrees using electronic track and trace technology, including RFID, would provide an electronic safety net for our nation’s drug supply. It is recommended that stakeholders continue to work expeditiously toward that goal, and that their implementation of RFID technology be used first on products most susceptible to counterfeiting and diversion.
The 6-9-06 Task Force report is the third in a series of documents exploring the means of ensuring the safety of the US drug supply. The first report, issued in 2004, outlined the framework for protecting the public from counterfeit medicines, and the second report, released last year, assessed the progress toward implementing the 2004 recommendations. All of the Task Force reports are posted on US FDA’s Web site at www.fda.gov/counterfeit.
About the Author
Joseph X. Phillips joined ISPE in 2003 as Regulatory Affairs Advisor and was appointed to the US Food and Drug Administration (FDA) as a special government employee on the Pharmaceutical Science Advisory Committee that is involved in the agency’s new “Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century” initiative. Previously, Phillips was Vice President, Pharmaceutical Services for Quintiles Consulting following a 44-year career with the FDA. At the FDA he served as Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A Guidance)
