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In the 60 days since Commissioner of Food and Drugs Mark McClellan, MD, PhD, announced the formation of an internal Counterfeit Drug Task Force, the task force has explored various options that could be taken to combat counterfeit drugs in the U.S. The interim report discusses potential options identified to date that may be included in the final report. This initiative is designed to enhance the existing safeguards that are in place to protect the nations drug supply.
The items in the report are called “potential options” because no decisions have been made with respect to anti-counterfeiting approaches. Rather, the potential options are based on what the Task Force has heard to date and it seeks comments and information on these options for use as a basis for the final report and recommendations of the Task Force. The Task Force believes that the potential options could be implemented together or independent of each other.
Although the safety and security of the U.S. pharmaceutical supply is high, FDA’s investigations show that counterfeiting of legitimate drug products poses a significant and growing problem. The Task Force believes that a multi-pronged anti-counterfeiting strategy is necessary to protect consumers by preventing the introduction of counterfeit drugs, facilitating the identification of counterfeit drugs, minimizing the risk and exposure of consumers to counterfeit drugs, and identifying, prosecuting, and punishing those responsible for counterfeit drugs.
None of the security, enforcement, education, compliance, inspection, regulatory, or other actions being considered can guarantee that counterfeiting will not occur in the U.S. However, our efforts are aimed at significantly increasing FDA’s and industry’s ability to protect the public health, while at the same time enhancing our ability to deter and detect counterfeit drugs in the U.S. drug distribution system.
The Task Force does not favor any particular technology, however, it believes that there are many current as well as new and emerging anti-counterfeiting technologies that could be useful in the manufacture, packaging, and labeling of drug products. The FDA intends to learn more about available technologies at the October 15, 2003 public meeting and technology forum, as well as through public comment on this interim report.
RFID is the placement of tiny electromagnetic tags on packages (or bottles, cases, and pallets) that transmit highly specific information about the contents of the package to an electronic receiver that in turn transmits the data to a database that keeps a record of the whereabouts of the package. RFID is currently undergoing testing to determine its feasibility, costs, and benefits in tracking and tracing the movement of drugs from the manufacturer to the dispenser.
The Task Force is exploring the uses of unit-of-use and tamper-evident packaging as possible measures that could be taken to deter and help identify counterfeit drugs. The Task Force is interested in public comment on the impact, costs, and implementation of such actions.
FDA is not aware of best business practices for manufacturers, repackagers, or pharmacists specific to the distribution of drugs in this country. Although there are regulations governing the manufacture and distribution of drug products (e.g., 21 CFR Parts 205 and 211), voluntary “best business practices” could be useful to supplement regulatory requirements. FDA is aware that the Healthcare Distribution Management Association (HDMA) has draft voluntary guidelines under development for pharmaceutical wholesalers.
Yes, we will be communicating with various stakeholders in an effort to ensure that the right people get the right message at the right time. To do this, the agency, in collaboration with other stakeholder groups, expects to 1) identify groups at risk 2) tailor relevant messages for each different group 3) and deliver those messages using the most appropriate tools to target each group. Armed with useful information, the public would then be better able to identify and avoid counterfeit drugs.
The Task Force will continue to gather information from stakeholders and members of the public as it prepares its final report for release in January 2004. As mentioned above, as part of this effort, the Task Force will hold a public meeting and technology forum on October 15, 2003. The Task Force will review this information, as well as comments received on the interim report submitted to the docket.
Because the Interim Report contains potential options for public comment, risk based analyses of the options have not been performed. The Task Force seeks data and information from stakeholders and the public that would be useful in conducting these analyses.
We all have a responsibility to protect the U.S. drug supply. We expect that consumers, pharmacists, other health care providers, manufacturers, wholesalers, repackagers, and others in the U.S. distribution chain can be educated to detect counterfeit drugs.
Yes. Importation of drugs from foreign countries creates a portal of entry for counterfeit drugs to enter the U.S. distribution system. Counterfeiters could take advantage of this entryway by substituting counterfeit drugs for authentic drugs and sell them to U.S. wholesalers or other unsuspecting entities. Importation also provides an avenue for adulterated, unapproved, and outdated drugs into the U.S. distribution system.
FDA planned this public meeting in order to hear public comments on ways to combat counterfeit drugs. The objective of the meeting is for FDA to gather information to assist the Counterfeit Drug Task Force in finalizing its report. We anticipate that discussions at this meeting will include presentations from members of the public, in particular, regarding the potential options described in the interim report, as well as the questions posed at the end of the interim report. The notice of the meeting also listed questions that the Task Force would like addressed by presenters at the meeting.
Information about the Counterfeit Drug Initiative public meeting can be found at http://www.fda.gov/oc/initiatives/counterfeit/. The meeting notice contains registration information regarding attending the meeting, presenting at the meeting, and displaying technologies at the technology forum. Interested persons should note that there are deadlines for registration.
The technology forum is being held to educate the FDA and other attendees of the types of anti-counterfeiting technologies that are currently available to deter and detect counterfeit drugs. It also provides an open forum for information exchange. In particular, FDA is interested in products that are currently in commercial use or production or that are used in the pharmaceutical distribution system or have clear applicability to authenticating or tracking pharmaceuticals (e. g., track/trace products, covert and forensic technologies that have applicability for pharmaceuticals.)
Interested persons may submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, written or electronic comments by November 3, 2003. Electronic comments can be submitted to http://www.fda.gov/dockets/ecomments. Groups should submit two copies. Individuals may submit one copy. Comments should be identified with the docket number 2003N-0361. You should annotate and organize your comments to identify the specific options or questions to which they refer. To ensure timely handling, the outer envelope should be clearly docket number 2003N-0361.
Additional Information:
Press Release
Report
( PDF version
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Federal Register