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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Force Report October 2003 - BACKGROUND: VULNERABILITIES IN THE U.S. DRUG DISTRIBUTION SYSTEM

In order to better understand how counterfeit drugs are introduced into the U.S. marketplace, the Task Force examined the drug distribution system in the U.S. to better understand existing vulnerabilities.1

A. The Drug Distribution System

Congress created a framework of laws intended to maintain high public confidence in the U.S. drug distribution system and the safety and efficacy of drug products. States also have enacted laws and regulations that are intended to complement Federal oversight to further protect the integrity of the U.S. drug distribution system. Together, State and Federal legislation and regulations work to provide security in the nations drug supply.

The Task Force reviewed and considered information from published reports, criminal investigations, and other sources describing the drug distribution system. What follows is a brief summary of what the Task Force has learned to date.

There are three large wholesalers who account for about 90% of the primary wholesale market. In addition, there are many smaller wholesalers who may have full or partial product lines and who may or may not sell nationally or regionally. Some of these wholesalers concentrate in the “secondary” wholesale market, i.e., they purchase selected drug products from wholesalers and they resell to other wholesalers, including large wholesalers, as well as pharmacies. They generally purchase discounted drug products. There are many reasons why sales from one wholesaler to another may benefit consumers. These may include: 1) taking advantage of price discounts available on certain legitimate drug products, (e.g., when a manufacturer or wholesaler has a temporary overstock or purchases excessive product on speculation that the manufacturer will raise prices), 2) low volume transactions (e.g., involving drugs that are used only occasionally in special populations), 3) quick turnaround (e.g., permitting a wholesaler or pharmacy to meet a temporary and unexpected increase in demand for a drug), or 4) sale to a remote area (e.g., sales to a small rural community). Figure 1 depicts drug distribution models in the U.S.

Figure 1

link to long description for Drug Distribution Models October 2003 Task Force Report

[Figure 1 depicts three models showing the movement of drugs through the U.S. drug distribution system. (The dotted lines indicate potential illegal sales.) In the simplest situation, the manufacturer sells directly to a retailer. However, in many instances, there can be one or more wholesalers, or even a repackager, who handles the drug before it reaches the retailer. It is in these intermediate steps, particularly when the wholesaler(s) and/or repackager(s) obtain products from sources other than the original manufacturer, that the greatest opportunities for compromising the security of the U.S. distribution system exist.]

B. Sources of Counterfeit Drugs

For a variety of reasons, counterfeit drugs currently are most likely to be introduced as part of a drug distribution process involving multiple wholesalers. However, it is important to recognize that criminal activity to introduce counterfeit drugs can occur at any stage in the drug distribution system, so that safeguards are needed in all of the transaction processes.

Many drugs in the distribution system are also “repackaged”. In the U.S., wholesale drugs in bulk containers are often repackaged into smaller containers prior to sale to an end user. Repackaging operations are performed by independent entities, wholesale distributors, or by distribution centers owned by large pharmacies. In the current distribution system products are repackaged for several legitimate reasons, such as to improve efficiencies for automated systems. In Europe, products are packaged in quantities that relate to a course of treatment (unit of use,) in general, obviating the need for repackaging.

The Task Force heard from law enforcement personnel that when counterfeit drugs are identified, they are often associated with diversion of the drugs that they purport to be. Diversion is the sale of drugs outside of the distribution channels for which they were originally intended. Diverted drugs can originate domestically, when there is illegal redirection of prescription drugs from other legitimate sources, such as free samples supplied to health care providers or lower-priced drugs intended for nonprofit clinics or Medicaid programs. Additionally, diverted drugs can originate in a foreign market, when donated or lower-priced product intended for use in one country is diverted to another country where the market price is higher. Counterfeit drugs generally are associated with the practice of diversion. Our current regulatory system does not have legitimate, regulated channels for such diverted drugs (even if authentic) to re-enter the drug distribution system. Consequently, there is no reliable mechanism in place to distinguish effective authentic lower-cost drugs from drugs that simply appear to be so, but are not legitimate and may be harmful.

Diversion facilitates the entry of counterfeit drugs into the U.S. distribution system because those individuals or entities that sell or purchase diverted drugs are less able to verify the integrity of these drugs, because they are purchased outside the normal distribution chain and without the usual regulatory safeguards. As a result, counterfeit, substandard, or otherwise adulterated or misbranded products may become commingled with authentic drugs in the U.S. distribution system. Because counterfeiting is often associated with drug diversion, steps to secure the drug supply against counterfeits may also make criminal drug diversion more difficult.

C. Points of Vulnerability in the U.S. Drug Distribution System

As noted above, some business practices that may serve certain desirable purposes, such as discounted pricing, can create opportunities for criminals to introduce counterfeit drugs into the drug distribution system. These practices represent potential vulnerabilities in the drug distribution system and require a high level of diligence by participants in the drug distribution chain in order to deter and detect counterfeit drugs. A more secure distribution system should include additional features to prevent counterfeit entry beyond the practice of due diligence by all participants.

For reasons that often benefit consumers, a manufacturer may sell a drug product at lower prices to certain end users or wholesalers. When this happens, the cost differential between the discounted price and the market price (which is based on the manufacturer’s usual list price and paid by other end users) can foster multiple profitable transactions before sale to an end user. Both wholesalers and end users who purchase drug products at discounted prices can initiate this chain of transactions. A drug product undergoing multiple transactions between the time it is sold by the manufacturer and the time it is bought by an end user, should be properly authenticated (e.g., via inspection, examination of the product's pedigree, or use of track and trace technology) by each purchaser in order to minimize the possibility that a counterfeit product has been substituted by an unscrupulous entity during one of the transactions.

Therefore, lack of a high level of diligence by members of the U.S. drug distribution chain can facilitate the introduction of counterfeit drugs into the drug U.S. drug supply. Investigations performed by Federal and State authorities have repeatedly shown the existence of illicit nationwide networks designed to capitalize on the inadequate due diligence performed by members of the drug distribution system in order to introduce potentially unsafe diverted and counterfeit drugs into the U.S. drug distribution system.

As drug prices continue to rise, opportunities to obtain lower cost drugs become increasingly important. However, because potential cost savings from discounted pricing provides a target for counterfeiters, the need for due diligence in this circumstance, particularly when multiple transactions occur, also increases.

However, even with a heightened level of vigilance by parties participating in single or multiple transactions or by those seeking lower-cost versions of drugs, there are weaknesses in the drug distribution system that can facilitate the entry of counterfeit drugs. Below, we discuss in more detail, several points of vulnerability in the U.S. distribution system that the Task Force identified.

  • Incomplete Pedigrees—A pedigree is a statement of origin that traces the drug from the point of manufacture and contains information about all transactions that the product undergoes until it reaches the end user. Products that have incomplete pedigrees, such as pedigrees that do not include all the transactions involving a drug from the time it leaves the manufacturer to the time it is sold to a consumer, make it more difficult to track and trace the authenticity of those drug products than products that have more complete pedigree information.
  • Inadequate or No Authentication—It is important for purchasers in the U.S. drug distribution chain to ensure that the product they are purchasing is the genuine article (i.e., authenticate the product). Tools and processes are readily available to copy drug products and their labeling and packaging to such an exact degree that even the manufacturer of the authentic product cannot tell if it is real or fake. On the other hand, technologies are also available (or will be in the near future) to identify whether the product that they are purchasing is authentic or counterfeit. Unfortunately, these authenticating technologies often are not incorporated into the drug product, labeling, or packaging.
  • Importation—Prior to the passage of the Prescription Drug Marketing Act (PDMA), including section 801(d)(1), drugs manufactured in the U.S. could go to a foreign market and then be reimported into the U.S. This became a common entry point for the introduction of adulterated and counterfeit drugs into the U.S. drug distribution system. Such products posed a public health problem because they were found to be subpotent, lacked active ingredients, contained ingredients that could pose a severe health hazard if taken by a susceptible person (e. g., aspirin), lacked adequate labeling, or were not approved drug products. For example, pre-PDMA, in 1985, over 2 million counterfeit tablets of Ovulen-21 from Panama were widely distributed throughout the U.S. Similarly, in 1985, a counterfeit version of Ceclor, an antibiotic widely used at that time, found its way into the U.S. drug distribution from a foreign source.
    In response to this public health problem, Congress passed PDMA, which prohibits reimportation of drugs by any entity other than the manufacturer. Figure 2 depicts the path of a drug in the U.S. distribution system, both before and after passage of the PDMA. The FDA and the States do not have oversight or authority over the foreign marketplace. Under current law, the FDA only has authority over foreign manufacturers when they submit to FDA oversight as part of a new drug application. (See 21 USC 355.) In addition, under current law, FDA has no authority to inspect or assess the practices used in foreign drug distribution systems. Obtaining drugs from a foreign distribution system further exacerbates existing vulnerabilities, similar to, but more severe than, those that facilitate domestic diversion. (See Figure 1, Model 3.) However, unlike entities engaged in domestic diversion, foreign counterfeiters remain outside the reach of U.S. law enforcement. Congress prohibited reimportation to protect American consumers from receiving counterfeit, substandard, or otherwise adulterated drugs.

    Furthermore, when consumers order medications from outside the U.S. (e.g., internet purchases, cross-border purchases), whether safe or unsafe, a portal of entry is created for counterfeit drugs into the U.S. distribution system. Counterfeiters can take advantage of this entryway by combining many small purchases from foreign countries into one and selling them to U.S. wholesalers or other unsuspecting entities. Due to the extensive resources involved in preventing small quantities of drugs from entering the U.S., as the volume of unapproved drug imports increases, it is more difficult for FDA to use its existing resources to identify and stop unsafe importations.

    Pre-PDMA Drug Distribution from Manufacturer to Foreign Market to US Wholesalers to Retailer. Post-PDMA Foreign market in not included

  • Repackaging—Repackaging may destroy anti-counterfeiting measures used in the original packaging and labeling of the drug. It may also provide a point of entry for expired, adulterated, or counterfeit drugs into the distribution system because they may be repackaged in a way that makes them appear to be legitimate products. Lastly, counterfeit and diverted product may be commingled with authentic product during the repackaging process and find its way to an end user.
  • Tamper-Evident Packaging—Currently, many prescription drug products do not utilize tamper-evident features. Without tamper-evident features, the original packaging may be reused for counterfeit or diverted product and thereby be more easily passed off as legitimate product. The reuse of old prescription drug containers found in trash facilities or taken from hospitals and clinics is also a significant problem because no tamper-evident feature has to be replicated, thereby enabling easy reuse of the packaging to distribute counterfeit, adulterated, or unapproved drugs. While tamper-evident packaging is important, it is also worth noting that counterfeit drugs can be repackaged into legitimate-appearing packaging (including features intended to mimic legitimate tamper-evident features), so that packaging alone cannot assure that drugs have not been counterfeited.

D. Background: Regulatory and Legislative History

1. Prescription Drug Marketing Act

As previously alluded to, Congress addressed some of these vulnerabilities by enacting the PDMA in 1988, which was amended in 1992 by the Prescription Drug Amendments. Among other things, the PDMA:

    • requires State licensure of wholesale distributors of human prescription drugs;
    • requires wholesale distributors of human prescription drugs in interstate commerce to provide a statement of origin, also known as a drug “pedigree”, which traces each prior sale, trade, or purchase of the prescription drug, to and from each wholesale customer prior and subsequent to the sale of the drug to that wholesaler, but exempts manufacturers’ “authorized distributors;”
    • with certain exceptions, prohibits the resale of prescription drugs that have been purchased by a hospital or other health care entity or that have been donated or supplied at a reduced price to a charitable organization.

In 1999, FDA published final regulations implementing the provisions of the PDMA. The provisions concerning the pedigree requirements at 21 CFR 203.3(u) and 203.50 were stayed by FDA because of valid concerns expressed by industry, trade associations, and Congress about implementing these provisions. Such concerns included the high cost and logistics of maintaining a pedigree and occasional inability to obtain a transaction history from the prior distributors and the manufacturer, thus calling into question the usefulness of the pedigree. Taking steps to address these requirements using traditional methods could impose substantial costs, at a time when access to affordable drugs is also a major policy concern.

In 2000, FDA held a public hearing to discuss these concerns. In 2001, FDA submitted a Report to Congress outlining the concerns raised by the secondary wholesale industry. The agency noted that in order to enable secondary wholesalers to fully comply with the pedigree requirements, Congress would have to amend section 503(e) of the Act to enable them to get the transaction history from all prior purchasers of the drug (because, currently, wholesalers who are authorized distributors of record are exempt from providing this information.)

In order to give Congress time to consider the information and conclusions contained in the agency’s Report to Congress and to determine if legislative action was appropriate, FDA subsequently instituted an additional stay of the provisions until April 1, 2004.

In addition to being costly, tracing a drug pedigree on paper, as envisioned in the PDMA, is subject to multiple record keeping failures, and may be subject to fraud. As discussed below, there are many promising developments in anti-counterfeiting technology that will enable the creation of an electronic pedigree for a drug product, thus reducing the need for paper pedigrees. Other steps discussed below can also help address the weaknesses identified in the PDMA. These new approaches are consistent with the desired movement toward electronic health information systems to prevent errors and adverse events, and would also make it easier to maintain the high level of diligence needed throughout the drug distribution system to prevent the introduction of counterfeit drugs.

2. Model Practice Act

As part of the implementation of PDMA, in 1990, FDA published a final rule containing “Guidelines for the State Licensing of Wholesale Prescription Drug Distributors.” The guidelines were codified at 21 CFR Part 205. The guidelines include the minimum standards, terms, and conditions for the storage and handling of prescription drugs and for the establishment and maintenance of records of their distribution. The guidelines followed, among other things, the “Model Regulations for Wholesale Drug Distribution” (Model Rules) issued by the National Association of the Boards of Pharmacy (NABP), which were previously issued as an example for States to adopt in order to comply with the PDMA. Subsequently, all 50 states have enacted some sort of legislation to implement the PDMA.

As the introduction of counterfeit drugs has increased over the past several years, some states, such as Florida and Nevada, have adopted laws and regulations with more stringent requirements intended to minimize the risk of counterfeit drugs appearing in their state. The Task Force believes that such steps could have an impact on the nationwide problem of counterfeit drugs.

To this end, the Task Force is working closely with the NABP to update the Model Rules and is in the process of reviewing the 50 state practice acts that govern wholesale distribution of prescription drugs, identifying strengths and weaknesses of those acts, and suggesting where the Model Rules can be updated. Based on its findings to date, the Task Force views the following as important areas for States to focus on in updating their Model Rules: requirements for licensure, qualifications of employees, handling and storage of drugs, site security, inspection and examination of drugs, record keeping, availability of records to inspectors and law enforcement personnel, due diligence, administrative subpoena power, and criminal penalties.

3. Penalties and Enforcement

The Task Force has reviewed the current applicable criminal statutes and sentencing guidelines for various types of counterfeiting and has found that the penalties for counterfeiting drugs are substantially less than for other types of counterfeiting, such as counterfeiting registered trademarks. For example, counterfeiting a prescription drug label (bearing a registered trademark) is punishable by up to ten years in prison, while counterfeiting the drug itself is punishable by a maximum of only three years in prison. Also, the U.S. Sentencing Commission guidelines currently include FD&C Act felonies at the lowest level of all federal crimes. Yet, counterfeiting of drugs may create substantial risks to the health and safety of a large number of consumers.

The Task Force has reviewed the statutes under which drug counterfeiting charges may be brought, as well as provisions that may streamline investigations and facilitate the seizure of counterfeit drugs and the forfeiture of illegal proceeds. The Task Force heard from some organizations that, as implemented to date, these penalties may not be severe enough to deter and punish those responsible for counterfeiting drugs.

The Task Force also reviewed the subpoena authority currently available to certain regulatory agencies, such as the Internal Revenue Service and the Bureau of Customs. The subpoena authority of those agencies is related to their statutory roles and responsibilities, and in conjunction with their other authorities, supports the efficient execution of their mission when other approaches (e.g., surveillance and tracking systems) are unable to provide the information required to address public threats.

E. Background: Technology Issues

1. Types of Anti-Counterfeiting Technologies

Two types of anti-counterfeiting technologies have existed for many years:

  • Authentication technologies, and
  • Track and Trace technologies.

Authentication technologies fall into three groups:

  • Overt technologies are protective measures that are easily visible to the eye, such as holograms, color shifting inks, and some watermarks.
  • Covert technologies are protective measures that are not visible to the eye and frequently require special equipment for visualization (and authentication). These include some watermarks, certain inks and dyes that fluoresce or absorb ultraviolet light, and invisible bar codes.
  • Forensic technologies are protective measures that require sophisticated analytical equipment, usually found in a forensic chemistry lab, in order to be identified. These include chemical markers, taggants, and other unique chemical properties of a substance.

Track and trace technologies include:

  • Radio-frequency identification (RFID) is a technology that involves the placement of electromagnetic chips/tags that contain product specific information onto cartons, pallets, and individual products. The system includes the tags, antennae affixed to the tags, readers to receive the data in the tags, and an information database that is used to authenticate and track the product as it moves through the distribution system.
  • Barcodes are symbols (representing an alpha numeric value) printed on labels that are read by a scanner and used to identify drug products. Bar codes can be combined with covert elements (e.g., security ink) that also allow them to function as authentication technologies.
  • Appendix A to this report contains a list of some basic types of authentication and track/trace technologies along with some of their capabilities and limitations.

2. Utilization of Anti-Counterfeiting Technologies

The Task Force recognizes that the functions of authentication and track/trace technologies are complementary. In order to reduce the likelihood of counterfeit drugs being introduced, and to increase the likelihood of identifying counterfeit drugs in the U.S. drug distribution system, both technologies should be utilized. The information reviewed by the FDA to date demonstrates that no single authentication or track/trace technology is a complete solution to facilitating the identification, and preventing the introduction, of counterfeit drugs into the marketplace. Law enforcement officials and other government agencies shared with FDA their experiences with counterfeiting of currency, credit cards, checks, and other documents. Their universal advice is that multiple technologies and measures must be utilized because determined counterfeiters are able to defeat many anti-counterfeiting measures within 18-24 months after the measure is implemented. Therefore, multiple strategies and a continuous evolution of technology are necessary to thwart criminal activity.

The Task Force has heard that track/trace technologies should be incorporated at the point of manufacture, used throughout the distribution system, and inactivated/destroyed at the time of dispensing. When track/trace technologies are used at a pallet and case level, they have the capability of following the product at each point in the distribution chain. To be maximally effective for authentication purposes, track/trace technologies should be incorporated at the product (individual package) level in addition to the case and pallet level so that individual product, rather than only bulk shipments, can be followed.

The Task Force has learned that the use of radio frequency identification (RFID) chips is undergoing pilot testing in several venues; however, widespread use of RFID may not occur for several years. Aside from the need to work out technical problems, (e.g., attaining 100% read rates,) a significant reason for this delay is that RFID and some other sophisticated technologies will not work without a system-wide infrastructure and an integrated database. An integrated database is one that is accessible to all users in the distribution chain for viewing data and contributing to the tracking of a particular product. Such databases and the associated “reading” technologies could take several years to develop and gain widespread adoption throughout the marketplace. Issues that need to be resolved include: Who will create the database? Who will own the data? And, who has access to the data?

If all entities in the drug distribution chain use RFID chips or other electronic track/trace technology, an “electronic pedigree” will be created de facto for the product. An advantage of an “electronic pedigree” is that it is harder to forge than a paper pedigree. However, for an electronic pedigree to become universally adopted, industry or national standards would have to be developed and implemented.

The Task Force has learned that the use of authentication technologies varies by pharmaceutical company and product. In general, authentication technologies are more widely used than track/trace technologies. However, the way they are used and the number that are used vary. For example, the Task Force has learned that combinations or layers of authentication technologies are more likely to be used in products at high risk for being counterfeited. On the other hand, products considered to be at lower risk may have fewer anti-counterfeiting measures incorporated into their manufacturing, packaging, or labeling.

Moreover, in the event that a suspect counterfeit product is found, there is a need for FDA and stakeholders to rapidly identify whether the labeling, packaging, and product are authentic. Currently, there is no database for FDA, other government regulatory agencies, or stakeholders to use which contains up-to-date information about authentic products, packaging, labeling, and utilization of anti-counterfeiting measures. Such a database could expedite confirmation of a suspect counterfeit drug product’s authenticity.

3. Cost/Benefit of Anti-Counterfeiting Technologies

The Task Force has heard a great deal about the costs of adopting anti-counterfeiting technologies. These include costs associated with:

  • Purchase of the technology;
  • Purchase of associated equipment (e.g., barcode scanners, RFID receivers, access to electronic databases) and services;
  • Integrating the technology into the manufacturing process;
  • FDA review, if required, for the technology;
  • Adopting new anti-counterfeiting measures as old ones are defeated;
  • Creation of infrastructure throughout the distribution system.

To date, the Task Force has heard less about the potential benefits of adoption of anti-counterfeiting technologies beyond greater assurance of drug safety. In addition to the public health and economic benefits associated with a reduction in the number of counterfeit drugs, other benefits may include:

  • Improved inventory management and control (with resulting reductions in inventory expenses for distributors and pharmacies);
  • Reduced labor cost due to automation;
  • Reduction in theft and product loss due to other causes;
  • Reduction in the amount of diverted product;
  • Improved ability to recall product;
  • Protection of drugs from intentional tampering;
  • Protection of drugs from being used in an act of terrorism.

An area of focus for the Task Force as it gathers more information on anti-counterfeiting technologies will be to find ways to maximize the benefits of new anti-counterfeiting measures while minimizing their costs.

F. Background: Health Professional and Industry Issues

1. Secure Business Practices

Given the complicated nature of many features of the drug distribution system, the business practices of the entities involved in those transactions (e.g., wholesalers, repackagers) plays a critical role in determining the ability and likelihood of introducing counterfeit drugs into the supply chain. These business practices may also play a role in the ability of stakeholders to identify counterfeits before they reach a consumer.

Industry practices in such areas as recordkeeping, inspection and examination of drugs, facility and information security, package disposal, performance of ‘due diligence’ on business partners, and establishing criteria for determining with whom they do business are all crucially important for the integrity of the drug distribution system.

Based on its research to date, the Task Force is not aware of any pertinent benchmarks or industry standards for business practices among pharmaceutical manufacturers, wholesalers, repackagers, and pharmacies with regard to the sale and purchase of drugs. The lack of adequate benchmarked industry standards is important because legitimate businesses are often involved in the purchase and sale of counterfeit drugs and therefore can be involved, unknowingly, in allowing counterfeit drugs to reach consumers. In addition, the lack of such standards creates opportunities for criminals to introduce unsafe drugs into the U.S. drug distribution system.

The Healthcare Distribution Management Association (HDMA) has submitted a draft document entitled “Recommended Guidelines for Pharmaceutical Distribution System Integrity,” which was endorsed by the Pharmaceutical Distributors Association (PDA), for the Task Force to consider in its deliberations. The document is a set of draft voluntary guidelines for pharmaceutical wholesalers to use for screening another pharmaceutical wholesaler prior to establishing a business relationship. It emphasizes the need to perform “due diligence” by requesting certain information, performing background checks, and inspecting the facilities of the potential business partner.

The Task Force will continue to work with HDMA, PDA, and others to gather information about current and best practices in the pharmaceutical industry prior to considering any final recommendations about the nature and extent of any changes to current industry practice that might reduce the risk of counterfeit drugs entering the distribution chain.

2. Rapid Alert and Response Systems

Identifying suspect counterfeit drugs in the distribution system is important to prevent sale of the counterfeit product to the patient. While consumers can help, wholesalers, distributors, repackagers, and pharmacists are often best situated to identify and report suspect counterfeit drugs. Recognizing this important role, the Task Force believes that steps should be taken to facilitate reporting of suspect counterfeit drugs and that a central FDA voluntary reporting mechanism be used for reporting by the public.

Recently, a variety of industry groups have begun to take voluntary steps to address this problem. For example, earlier this year, the pharmaceutical industry announced a voluntary program, whereby Pharmaceutical Research and Manufacturers of America (PhRMA) member companies agree to notify FDA’s Office of Criminal Investigations (OCI) within five working days of determining that there is a reasonable basis to believe that a product has been counterfeited. OCI has received several reports since that April 2003. OCI is currently working with industry to standardize reporting requirements and otherwise improve communications. The program also applies to counterfeits discovered in foreign countries if there is clear evidence that the counterfeits are intended for distribution in the United States. HDMA recently announced similar steps that their member companies will take in notifying FDA of suspect counterfeit drugs.

Currently, health care professionals and consumers use FDA’s MedWatch system for reporting adverse events associated with medical products as well as product problems. Policies and procedures are in place to ensure that the information is conveyed to appropriate agency personnel for follow up. For example, if there is a problem with a product (e.g., broken tablets, lack of efficacy) the information is analyzed and/or investigated to determine whether there are steps manufacturers may need to take to correct the problem. Additionally, over 150 health care professional, consumer, and trade organizations have partnered with MedWatch to help disseminate information and alerts generated by MedWatch. The Task Force believes that this system can be adapted to receive reports of suspect counterfeit drugs and communicate important information in the event a counterfeit drug is identified.

As described below, the Task Force is exploring the creation of a counterfeit drug alert network, which would draw on all of these elements and could be utilized to disseminate information when a counterfeit drug is identified. Such a network also could be used as a vehicle for educational messages.

G. Background: Education and Public Awareness Issues

The Task Force believes that an educated, vigilant public is an invaluable defense against counterfeit drugs filtering into the U.S. pharmaceutical market. Consumers and health professionals need to know how to proactively avoid these counterfeits. They also need to be familiar with what to look for when faced with a potential counterfeit and the steps that need to be taken if they are suspicious that they have encountered one.

The Task Force explored what appropriate role FDA and its partners could play to educate potentially affected groups. A logical first step to take would be to identify specific stakeholders that would most likely be affected by counterfeit drugs. The next step would be to craft appropriate messages and identify effective communication tools to accurately reach these diverse stakeholders. This step is very important because various communities and professional groups receive health information in different ways.

The Task Force recognizes that once a counterfeit is identified in the stream of commerce, public officials must quickly act to remove the counterfeit drug from the marketplace. However, at the same time, while getting this information out to the public, officials need to take care not to alarm unaffected consumers, thereby causing them to discontinue necessary therapy. The FDA has long held the position that protection of the public health will remain its number one mission, even if public notifications of a counterfeiting scheme might hinder the criminal investigation to determine who is responsible for the counterfeiting.

As part of its assessment of current communication channels, the Task Force consulted with numerous agency components that oversee communication channels potentially pertinent to anti-counterfeit communications. Information from consumer groups, health care provider associations, media representatives, trade organizations, and representatives of state governments/enforcement groups was also reviewed to better understand the current information flow processes between the FDA and outside stakeholders.

Based on this information, the Task Force made the following preliminary assessment:

  • There is a need for more comprehensive efforts to educate the public about the threat of counterfeit drugs, how to identify them, and how to minimize the risk of receiving counterfeit drugs. Figure 3 is an example of the type of educational messages that may be used in an educational campaign.
  • Efforts to educate pharmacists and other health professionals about current counterfeit events and how to handle these situations exist, but could be improved.
  • When a counterfeiting event occurs, there are sometimes delays of varying degrees in alerting and updating the appropriate health professional about the problem. When the messages are delivered, they may not be adequately tailored to the various audiences to be helpful to them. Also, stakeholders complain they have to work too hard to access timely, accurate information - a proactive alarm system was named as a potential solution
  • There may be additional opportunities to work with health care providers and manufacturers to capture data that may help identify counterfeits.

What Can Consumers Do to Protect Themselves from Counterfeit Drugs?

  1. To avoid purchasing "buyer beware" drugs, it's safest to purchase ONLY from U.S. state-licensed pharmacies, where the FDA and state governments can assure the safety of drug manufacturing, packaging, distribution, and labeling.
  2. If purchasing over the internet, make sure the website has the Verified Internet Pharmacy Practice Sites Seal (VIPPS).
  3. Be vigilant about your medicine. Check for changes in packaging, labeling, color, taste, or shape of a pill. Look out for unanticipated side effects.
  4. If you suspect you have a counterfeit drug:
  • Contact the pharmacist that dispensed the drug; OR
  • Call 1-800-FDA-1088; OR
  • Contact your doctor.

 

1 The Food Drug and Cosmetic Act (the Act) defines a counterfeit drug as “a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.” (21 U.S.C. 201(g)(2))