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U.S. Department of Health and Human Services


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A. Questions Concerning Technology (Options 1-9)

1. Discuss the advantages and disadvantages of unit of use packaging. Please provide any information on the economic impact of requiring unit of use packaging.

2. Should the European Union requirements be used as a model for unit of use packaging?

3. Discuss the advantages and disadvantages of using tamper evident packaging on drug products. Please provide any information on the economic impact of requiring tamper evident packaging features on these products.

4. What anti-counterfeiting technologies are currently being used? Are there any data on which technologies are successful?

5. What, if any, minimum number of anti-counterfeiting technologies should be utilized on packaging and labeling? Should technologies be utilized on all dosage forms (e.g., APIs, finished dosage forms) and products or just dosage forms and products at high risk of being counterfeited?

6. Should any specific anti-counterfeiting technologies be utilized? Should covert technologies always be utilized? Should overt technologies always be utilized?

7. Should some anti-counterfeiting technologies only be identifiable by the manufacturer and/or the FDA?

8. On what dosage forms and products should taggants, other markers, or unique characteristics be utilized? All dosage forms and products? High-risk dosage forms and products? Are there unique characteristics of products that can be utilized in lieu of taggants or chemical markers for forensic analysis?

9. What role should the FDA play in reviewing the use of (i) anti-counterfeiting technologies incorporated into the packaging and labeling, (ii) taggants, markers, and other unique characteristics incorporated into the product itself, and (iii) track and trace technologies?

10. How should “validation” of an anti-counterfeiting measure or track and trace technology be determined? Should only “validated” anti-counterfeiting measures be used? Who should do the validation?

11. Should a database, as described in Technology Option 5 be created? If so, who should develop the database? Where should it be housed? Who should have access to the data? Who should be responsible for updating and maintaining it?

12. Discuss the advantages and disadvantages and the role of track and trace technologies, in particular bar codes and RFID.

13. What are the costs and challenges involved with setting up an infrastructure for utilizing various track and trace technologies?

14. Tracking and tracing drugs and biologics throughout the drug distribution chain may result in the creation of a large database that includes tracking data from each entity that “handles” the product. Who should create and maintain such data? Where and how should the data be housed? Who should have access to the data? How can appropriate confidentiality be assured?

15. Are there additional benefits beyond the ability to detect counterfeit product that anti-counterfeiting and track/trace technologies can provide for industry, (e.g., inventory control, facilitation of product recalls, and identification of theft and product diversion)? Give specific examples.

16. Discuss the logistic, economic, and public health effects of direct shipment of product to retailers and other end users.

17. For products that are shipped directly from manufacturers to retailers, would the use of track and trace technology on those products provide any additional benefits?

18. Should all products be considered at high risk of being counterfeited? How can products at high risk of being counterfeited be identified? Which, if any, of the following criteria should be considered: (a) potential impact on public health if the product were counterfeited, (b) any history of, or the potential for, counterfeiting, tampering, or diversion of the product, (c) wholesale and retail price of the product, (d) volume of product sold, both on a unit and dollar basis, (e) the dosage form of the product, e.g., injectable, (f) approved and unapproved uses of the product, (g) current and potential misuse or abuse of the product, e.g., “street value”, (h) other products in the class with a history of being counterfeited, (i) the length of remaining patent life for the product?

19. Discuss what could be included in an FDA guidance on the use of anti-counterfeiting technologies.

20. Should FDA conduct research on development or evaluation of anti-counterfeiting technologies? If so what should this research focus on? How should FDA integrate its research efforts with other public and private sector efforts?

21. Discuss what could be included in an FDA guidance on physical site security and supply chain integrity.

B. Questions Concerning Regulatory Requirements and Secure Business Practices (Options 10-13)

1. Discuss the most effective ways to achieve the goals of the wholesale distribution rule (21 CFR 203.3(u) and 203.50). Given recent or impending advances in technology, comment on the feasibility of using an electronic pedigree in lieu of a paper pedigree.

2. Discuss the advantages and disadvantages of the new Florida and Nevada requirements for wholesale distributors, including the costs involved with compliance.

3. Discuss the advantages and disadvantages of requiring a pedigree if track and trace technology is also being utilized for a given product?

4. Identify areas where the NABP Model Rules for Licensure of Wholesale Distributors could be strengthened. Please give specific language for new provisions.

5. Discuss the strengths and weaknesses of a pedigree as a means of tracking product integrity. Is there a deterrent value in having a pedigree? What is the most cost-effective approach to obtaining reliable pedigree information?

6. Discuss the advantages and disadvantages of increased penalties for counterfeiting drugs?

7. Identify areas where business practices could be changed to prevent the introduction, and facilitate the identification, of counterfeit drugs.

8. Describe the current use of designated personnel and teams to implement and monitor anti-counterfeiting measures by manufacturers, wholesalers, re-packagers, and pharmacies.

9. Comment on the advantages and disadvantages of manufacturers sharing market data with the FDA for use in identifying counterfeit products.
10. Comment on the need for FDA guidance dealing with site security and supply chain integrity in light of the importance of drug treatment for bioterrorism incidents.

C. Questions Concerning Rapid Alert and Response Systems (Options 14-16)

1. What are the advantages and disadvantages of adapting the MedWatch system for use in disseminating information about counterfeit drugs?

2. What are the current capabilities of private communication systems or networks (e.g., association list-serves, websites) for handling information about counterfeit drugs in a timely manner?

3. What current electronic communication systems or networks are being used by the private sector to share information and can they be linked with MedWatch?

4. What capabilities should a communication network have in order to be part of a counterfeit alert system? For example: Should the system be accessible to all stakeholders (e.g., pharmacies, wholesalers)? How fast should the system be able to disseminate information about suspect product? Should messaging be active? How should the system flag messages about suspect product as opposed to less urgent information? Should access be at no cost? Should all networks in the system have a uniform method of presenting and distributing information? How secure must the system be? Should access to information be selective? Should the system be capable of direct linkage to the FDA? Should the system be able to transmit educational information?

5. What are the costs associated with developing a new counterfeit alert network? What are the costs associated with adapting current systems or networks to be part of a counterfeit alert network? (In both cases, having the features listed in (d) above)

D. Questions Concerning Education and Public Awareness (Options 17-21)

1. How can FDA best assist in making sure the public knows what they need to know to help them avoid counterfeit drugs?

2. What role should the private sector, professional/trade associations and consumer representatives play in educating consumers and health professionals? Are there other groups that FDA should solicit for help?

3. How should FDA interact with various private sector and trade groups to educate consumers about the threats of counterfeits before they enter the stream of commerce?

4. What education and communication tools are available? Which will be the most effective and efficient for this effort?

5. Once a counterfeit drug is identified, what tools are available to the agency to notify potentially affected parties without inappropriately scaring other consumers from taking their medications?

6. How should these efforts be supported or funded? Is partnership with potentially affected parties appropriate?

7. Are there additional long term messages, in addition to those listed above, that the FDA should deliver to its targeted audiences? Similarly, are there additional messages that the FDA should deliver when a report of a counterfeit product is received by the agency?

E. Questions Concerning International Issues (Options 22-23)

1. What measures have foreign governments instituted (or are planning to institute) to address the problem of counterfeit drugs?

2. What global standards are needed to address the problem of counterfeit drugs? Who should develop these standards?

3. What processes will be effective in setting global standards?