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Fda and counterfeit drugs, herbs and tinnitus - Reviews

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Over the past year, we have worked with manufacturers, wholesalers, pharmacies, consumer groups, technology specialists, standard-setting bodies, State and Federal agencies, international governmental entities, and others to advance the measures outlined in the Report. In 2004, FDA's Office of Criminal Investigations (OCI) initiated 58 counterfeit drug cases, a significant increase from the 30 cases initiated in 2003. Fortunately, most of the counterfeit drugs at issue did not reach consumers because we focused our limited resources and developed proactive investigations that enabled us to identify components of counterfeit products and interdict finished counterfeit drug products before they entered domestic distribution.
Although the number of counterfeit drug cases has increased and the threat to the public health is real, most of the suspect counterfeits that we discovered in 2004 were found in smaller quantities, compared to those found in 2003. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
In an effort to protect against the rising occurrence of potentially unsafe counterfeit drugs reaching consumers, FDA is announcing a new initiative to more aggressively protect American consumers from the risks posed by counterfeit drugs. In addition, counterfeiting in recent years has shifted increasingly into “finished” pharmaceuticals (the final product taken by the patient) as opposed to counterfeiting of “bulk” drug ingredients in the past. Even a small percentage of counterfeit drugs in the drug supply can pose significant health risks to thousands of Americans. Toxic Effects: Some fake drugs contain ingredients that, if ingested or injected, can cause health problems. Labels that look real: Over the past several years, counterfeiters have gained access to sophisticated technologies that enable them to very closely duplicate the packaging and labeling of legitimate prescription drugs.
Drugs purchased over the Internet by an American patient who was told that the products were manufactured in the United States and were being sold from Canada. In all of these cases, at a minimum, patients face the risk of therapeutic failures or worsening of the health problem that the drug was intended to treat. Because counterfeiting is difficult to detect, investigate, and quantify, it is hard to know the true extent of the problem.
In 1988, the Prescription Drug Marketing Act (PDMA) was enacted as an effort to ensure that prescription drug products in the U.S.
Some of its provisions have made it possible for determined counterfeiters to skirt its intent. Its reliance on paper records can be quite costly, especially for small- and medium-sized wholesalers. PDMA does not envision the use of modern technologies that can assist with tracking or verifying the authenticity of legitimate prescription drugs. In the 15 years since PDMA was enacted, there have been many changes in the industry and in anti-counterfeiting technologies, as well the introduction of electronic ordering, inventory control, and record-keeping used by the pharmacies—which may provide more effective mechanisms to achieve PDMA’s goals. Under a voluntary program just begun, drug manufacturers will notify FDA within five working days of determining that there is a reasonable basis to believe that a product has been counterfeited. While FDA is seeking to improve deterrence and detection of counterfeit drugs, enforcing the law against health care criminals is a core part of FDA’s efforts to protect Americans from counterfeit drugs. To respond to the increased sophistication and increased opportunities of drug counterfeiting before it becomes a widespread problem, FDA’s new Counterfeit Drug Initiative is designed to better identify the risks and threats from counterfeit drugs, to coordinate public and private efforts to fight counterfeiters, and to identify technologies and tools to aid in identifying, deterring, and combating counterfeiting. In about two months, the FDA task force will issue an interim report with recommendations for public comment. I am very pleased to have this opportunity to speak at the first, and hopefully not the last NACDS and HDMA Summit on the adoption of Radio Frequency Identification technology in health care. I am here to tell you that FDA shares your hopes about the promise that RFID brings for the distribution and delivery of health care products into the 21st Century. Successful adoption of electronic track and trace technologies like RFID will require unusually high levels of cooperation among all stakeholders in the manufacture and distribution of medical products. Today I would like first to discuss the policy problem that electronic track and trace technologies such as RFID can help solve, at least from the perspective of FDA.
Second, I would like to summarize for you the steps that FDA has taken recently to remedy this problem.
And finally, I will tell you what our plans are for helping drive adoption of an electronic pedigree and RFID and ensuring that Americans have the greatest possible assurance that their medications are safe and effective. We at FDA envision a world where devious would-be peddlers of diverted or fake medicines are thwarted and unable to sell to unsuspecting U.S.
We envision pharmacists at drug stores and hospitals being certain of the safety and efficacy of drugs they are dispensing, including their appropriateness for particular patients. This certainty comes not merely because the label conveys FDA approval but because an up-to-date electronic database confirms that the particular package contains the genuine authentic product--it was tracked at each stage of the distribution chain, from the FDA-approved manufacturing facility, to the dispensing pharmacist.
Further, the electronic track and trace system that will provide this certainty, offers such savings to private firms that the benefits of greater certainty about safety and efficacy are realized without any untoward increase in the costs of medications at a retail level. Let me elaborate why implementing this vision is important to combating the problem of counterfeit drugs.
While we have no direct quantitative evidence about the prevalence of counterfeit drugs, because they so successfully mimic genuine products and by all accounts are rare, we are confident that the overwhelming majority of prescription drugs sold in the U.S. We believe counterfeit drugs represent significantly less than one percent of the total U.S. Despite this high confidence, FDA has been concerned that the drug supply is under increasing threat of attack from ever more sophisticated counterfeiters. The Agency has witnessed an increase in counterfeiting activities and a greater capacity to introduce finished dosage form counterfeits into legitimate drug distribution channels.
As you can see from Slide 1, the number of newly initiated counterfeit drug cases has risen sharply from just a few years ago, although preliminary data from fiscal year 2005 suggest a decline relative to the peak reported for fiscal year 2004. Let me stress that these are estimates of the number of newly initiated counterfeit drug cases being investigated. We believe that the unusually high number of cases in FY2003 is in part due to an increased awareness and vigilance at all levels of the drug distribution chain.
The decline from 58 cases in 2004 to 32 new cases in 2005 may be due partly to a positive deterrent effect of the new 2004 cases on the level of counterfeiting in 2005. Fortunately, most of the counterfeit drugs at issue did not reach consumers because we focused our resources and developed proactive investigations.
It is important to note that the number of cases that OCI has opened is NOT an indication of the prevalence of drug counterfeiting in the U.S. FDA has tried to implement the Prescription Drug Marketing Act while encouraging the voluntary adoption of anti-counterfeiting technologies and practices. For those of you who are not familiar with PDMA, the Prescription Drug Marketing Act is a law passed in 1987 in response to a number of counterfeit drug incidents in the U.S. PDMA requires State licensing of wholesale distributors of prescription drugs and requires unauthorized wholesale distributors to provide purchasers a statement (also called a pedigree) identifying each prior sale of the drug.
Adoption and common use of reliable track and trace technology would be feasible in 2007, and would help secure the integrity of the drug supply chain by providing an accurate drug “pedigree”. RFID is the most promising approach to provide reliable and timely track and trace information. Adoption of electronic track and trace technology would help stakeholders meet and surpass the goals of PDMA. We are working closely with individual companies and supply chain partnerships who are implementing or piloting RFID, including several companies that are here today. EPCglobal has kindly welcomed FDA to meetings of its Health and Life Sciences Business Action Group, where much of the standard setting work is being done.
We have led an FDA RFID working group, in which all FDA centers are represented, information is shared within the agency, and consistent approaches are identified and pursued. In our February 2004 report, we took an essentially voluntary approach toward widespread adoption of electronic track and trace.

We also said that “we are pleased with the progress stakeholders, standard setting bodies, and software and hardware companies have made thus far toward implementing an electronic pedigree for drug products.
Let me turn now to our plans to renew and reinvigorate our support for RFID so as to accelerate its adoption. First, FDA, given its responsibilities for drug safety, must ensure that radio-frequency exposure does not impact the quality, safety, or efficacy of drug and biologic products.
We asked stakeholders to share data and information regarding the effects of RF on drug and biologic products. We believe, based on preliminary information and hypothesis, that RF does not have a significant thermal effect on solid dosage forms. An FDA CDRH lab has done some preliminary research looking at the heating effect of 915 MHz RFID fields on a placebo, simulating a pharmaceutical. We are developing protocols for further research, but we intend to look at RF effects on various types of drug, biologics, and various types of packaging materials under a variety of conditions. Second, I am pleased to announce here that the FDA Counterfeit Drug Task Force is going to hold a Public Workshop in January or February 2006. The new chairpersons of the Task Force are Maggie Glavin, Associate Commissioner for Regulatory Affairs and me. Our general interest is in identifying the current barriers to adoption and finding ways these barriers can be overcome. Should all of the transaction information be stored and accessible at a single central database or a distributed network of information. In the coming weeks, we will put out an invitation for people to testify on these and other issues and we expect to publish more information about this meeting in the near future both in the Federal Register and posted on FDA’s website.
We have been advocating the adoption and widespread use of electronic track and trace technologies for almost 2 years now. I believe that the steps that I have shared with you today—the public workshop and any follow up from that and the RFID research that we will be conducting, as well as our continued interactions and discussions with you and your companies, demonstrate our commitment to push this forward.
Avoiding the addition of unnecessary costs to the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.
FDA believes that counterfeiting is not widespread within the system of manufacturing and distributing pharmaceuticals legally in the United States, as a result of an extensive system of federal and state regulatory oversight and steps to prevent counterfeiting undertaken by drug manufacturers, distributors, and pharmacies. The body of this report contains a range of findings that have broad support from industry stakeholders and the public to identify and address the vulnerabilities in the U. The FDA is grateful for the input and universal support, not only with regard to the creation of the task force, but also with regard to the need for securing the nation's drug supply. We believe that this is in part due to an increased awareness and vigilance at all levels of the drug distribution chain as a result of the Combating Counterfeit Drugs Report released last year. 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. As part of this effort, FDA has created a new internal task force that will develop recommendations for steps FDA, other government agencies, and the private sector can take to minimize the risks to the public from counterfeit drugs getting into the supply chain. For example, the recently counterfeited Procrit, an important drug for cancer and AIDS patients, contained nonsterile tap water, which can cause an infection in the bloodstream. Others attempt to accurately copy the real drug, but still pose safety risks because they are not formulated in a way that achieves the right therapeutic levels in the patient’s blood. For example, a counterfeit version of Serostim, a growth hormone used in AIDS patients, was found to have no active ingredient.
Primary wholesalers purchase drugs directly from manufacturers and then sell the products directly to a pharmacy, hospital, institution, other dispenser, or secondary wholesaler. Outside the United States, drug counterfeiting is known to be widespread and affect both developing and developed countries.
The program extends to counterfeits discovered in foreign countries if there is clear evidence to believe that they are intended for distribution in the U.S.
Many of these counterfeit enforcement activities are the work of the FDA’s law enforcement arm, the Office of Criminal Investigations (OCI) in conjunction with other state and federal enforcement officers. A new internal FDA Counterfeit Drug Task Force will be charged with exploring measures to be taken to prevent patients being exposed to counterfeit drugs. The task force will examine currently available and potential, future, low-cost technologies that can be used to assure product and package integrity and track legitimate products through the distribution chain. The task force will seek to improve upon the current counterfeit alert system to enhance communication about known or suspected counterfeit products to all parties in the distribution supply chain. The group will identify mechanisms to strengthen the wholesale distribution system, such as helping create a model code of conduct for wholesalers and strengthen the model practice act for wholesale distributors for States to adopt. The task force will gather private sector information and collaborate with pharmacy and health professionals, drugs manufacturers and distributors, consumer organizations, and other stakeholders on how to best counter these criminal practices.
The group will recommend ways to educate consumers about steps they can take to minimize risks associated with counterfeit drugs. The task force will explore the potential deterrence and other effects of stiffer penalties on those found guilty of counterfeiting prescription drugs in the U.S. Following input from interested parties on the report and recommendations, FDA intends to finalize the report within six months and to issue a strategic action plan outlining pubic and private sector actions needed to address the growing concern about counterfeit drugs.
We at FDA congratulate HDMA and NACDS for organizing this meeting and greatly appreciate your ongoing commitment and work to advance current and emerging technology and business solutions--such as RFID--to combat counterfeit drugs and thereby improve the integrity and safety of the U.S.
Andy von Eschenbach, our Acting Commissioner is engaged, knowledgeable, interested, and supportive of RFID.
Increasingly sophisticated counterfeit drug organizations have posed an increasing threat to the integrity of the drug supply in the U.S. These include the February 2004 Report on Combating Counterfeit Drugs, and our efforts to encourage the voluntary adoption of RFID during the stay until December 2006, of the pedigree regulations issued under the Prescription Drug Marketing Act. While fighting counterfeit drugs is a key part of FDA’s mission to ensure drug safety, we acknowledge important public concerns about the cost of medications and the implications of high costs for access to drugs.
This disturbing trend is evident in the increased efforts to introduce counterfeit drugs into the U.S. Illicit wholesale drug diverters and others in the supply chain provide the window through which most counterfeit drugs have historically entered legitimate distribution channels. In fiscal year 2004, FDA's Office of Criminal Investigations (OCI) initiated 58 counterfeit drug cases, a significant increase from the 30 cases initiated in FY 2003.
Since these are ongoing cases, we have no estimate of the volume of counterfeit drugs involved in each case--it could vary from dozens to thousands. One factor contributing to this increased awareness and vigilance is the Counterfeit Drug Report that FDA issued in February 2004.
We believe that this strategy enabled us to identify components of counterfeit products and interdict finished counterfeit drug products before they entered retail distribution.
Counterfeit, stolen, and otherwise fraudulently obtained pharmaceutical drugs can enter legitimate channels through pre-existing illicit diversion networks. We participate in 4 sub-working groups on this panel, including privacy, standards, technology and policy.
Supply chain stakeholders assured us that there would be considerable movement toward implementation of RFID and that widespread adoption could be done in 2007. This has given us the impetus to develop and conduct our own studies to determine the impact of RF on a range of products. However, the agency has recently seen an increase in counterfeiting activities as well as increased sophistication in the methods used to introduce finished dosage form counterfeits into the otherwise legitimate U.S. In addition, this increase in investigations is due to increased referrals from and coordination with other state and federal law-enforcement agencies and communication with drug manufacturers.

Drug counterfeiting is a relatively rare event in this country; however, FDA has seen its counterfeit drug investigations increase to over 20 per year since 2000, after averaging only about 5 per year through the late 1990s.
While no fatalities have been causally linked to specific counterfeit drugs in the last decade, criminals who engage in such counterfeiting practices clearly have disregard for the well-being of ill patients and the safe practices of legitimate companies and individuals involved in the distribution of prescription drugs. For example, in South-East Asian countries approximately 10% of drugs on the market are believed to be counterfeit.
The PDMA sought to introduce safeguards into the drug distribution system to provide assurances through paper records of the true source and distribution history (“pedigree”) of a prescription drug.
These investigations have so far netted 44 arrests and 27 convictions, with a number of criminal investigations ongoing.
Bureau of Customs and Border Patrol to identify suspect packages that may contain counterfeit drugs that cross into the U.S. The program went into effect in May, and it has already been used to provide several reports of counterfeit drugs to FDA, including those involving Procrit, and Lipitor, a widely prescribed cholesterol-lowering drug.
For example, for the Procrit counterfeiting case, FDA’s OCI worked closely with Florida law enforcement officials in the investigation, arrest, and conviction of the counterfeiters. Customs and Border Protection, the task force will initiate a study of pharmaceuticals entering the United States at several major ports of entry, to better determine the type and extent of drugs arriving from overseas and the degree to which counterfeit drugs are among such imports.
Customs and Border Protection Service, the Treasury Department, the Department of Justice, and States, who have experience with counterfeiting. It will also educate consumers about what to look for, and what to do, if they suspect they have received a counterfeit drug. As makers, distributors, and dispensers of drug products, you have an obligation to maintain and guarantee the integrity of the drug products that you sell.
Lack of information in the drug distribution system is hindering efforts to ensure that each patient gets the right drug in the right amount at the right time.
Based on discussions with some drug companies and retailers, we believe that RFID can offer significant savings in the form of better inventory management to manufacturers, wholesalers and retailers alike. These laws require drugs to be treated as potentially dangerous consumer goods that require regulations and oversight by health professionals in order to protect the public health. A second is increased referrals from, and coordination with other state and federal law-enforcement agencies, and communications with drug manufacturers.
In reality we can not identify the exact causes of changes in the number of new counterfeit drug cases opened each year. OCI’s enforcement efforts targeting these diverters also have resulted in detection and dismantling of counterfeit schemes. We believed at that time regulatory intervention might stifle innovation and progress in adopting this emerging technology. Appendix B contains a more detailed discussion of the comments FDA received and considered in developing the final report.
In China, authorities believe that for some drugs, the estimated average counterfeit copies can be as high as 50%. These features could be used with existing packaging and the existence of such a mark would help consumers and pharmacists identify counterfeit drugs. RFID can both help you to meet this obligation and help us ensure that all drugs are safe and effective. While investments in some RFID technology may well make sense for some individual companies, the net benefits that all stakeholders will enjoy from RFID will be maximized only if independent organizations adopt common standards and compatible approaches. Other savings would stem from reduction in theft and product loss, improved recalls, and reduction in paperwork burdens.
The sophistication and precision of counterfeit copies make a reliable estimate of the number impossible.
Without the intimate knowledge of diversion borne of extensive investigative experience it would be difficult, if not impossible, to effectively combat pharmaceutical counterfeiting. As a result, FDA stayed certain provisions of the final rule, and has continued to stay these provisions. Let me be clear that this continues to be an Agency priority and we are prepared to give this another big push to keep the momentum moving quickly. FDA counterfeit drug investigations have increased to over 20 per year since 2000, after averaging only 5 per year through the late 1990's. Secondary wholesalers usually deal in smaller quantities and have higher turnover of stock. It is reported that in underdeveloped countries such as Argentina, Colombia, and Mexico, up to 40% of manufactured pharmaceuticals are believed to be counterfeit. FDA works closely with federal, state, and local agencies, as well as the private sector, to identify and track down drug counterfeiters. However, we believe that existing regulations and the commitments by most supply chain stakeholders to comply with these rules, keep very low the prevalence of drug counterfeiting in the U.S. The current stay, which expires in December 2006, was issued in part to give stakeholders time to implement an electronic track and trace technology solution. For example, recent reports have detailed that more than 50% of anti-malarials in Africa are believed to be counterfeit. But in some instances, some smaller wholesalers also knowingly or unknowingly take higher risks by obtaining drugs that may not have a clear “pedigree” traceable back to a legitimate manufacturer.
Much of the activity has targeted high volume, high cost drugs where counterfeiters attempt to make the most money possible in a short time period.
Thoughtful adoption of RFID, while helping you financially, will also offer a lower cost way of ensuring authenticity of drugs thereby providing key support for our fight against diversion and counterfeiting.
Thus, drug counterfeiting poses real public health and safety concerns today, and may pose an even greater threat in the future if we fail to take preventative measures now. In virtually all countries, counterfeit drug operations have been uncovered in recent years. Unlicensed or unregulated pharmacies may also knowingly or unknowingly distribute unapproved drugs. Drugs at risk for counterfeiting are often those found in the top 20 best selling prescription medications, including widely used cholesterol-lowering drugs, high blood pressure drugs, AIDS drugs, drugs used to raise red blood counts, and drugs used to fight depression. Moreover, it may be costly and time-intensive to use the tools required to authenticate such printed package labels.
As counterfeiters continue to seek out new technologies to make deceptive products and introduce them into legitimate commerce, our systems for protecting patients must respond effectively.
Also, these small drug shipments, when consolidated by the addressee, can find their way into the secondary wholesale market. FDA has alerted consumers in the past of the significant risks associated with drugs purchased over the internet from unknown sources. These technologies are able to transmit a great deal of very specific information about the product and can enable distributors and retailers to track products through the entire distribution network. Although many of these technologies are not now mature and have limitations, and further cost-benefit analysis is needed, they offer great promise as counter-measures to make legitimate prescription drugs more secure from counterfeiters.

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