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No. 1, February 2009
Meeting in Rome in February 2006, WHO launched IMPACT in order “to build coordinated networks across and between countries in order to halt the production, trading and selling of fake medicines around the globe.” The task force marshaled an impressive list of partners, including 193 WHO member countries, as well as organizations with expertise in enforcement, manufacturing, patient advocacy, and aid distribution: Interpol, the Organisation for Economic Co-operation and Development, the World Bank, the International Alliance of Patients’ Organizations, the World Medical Association, Pharmaciens Sans Frontières, and the major branded and generic pharmaceutical trade associations, among others. Each member had a unique interest in the project: national health authorities wanted to limit the amount of substandard drugs entering and being produced in their countries, enforcement agencies were attracted by growing evidence that counterfeit pharmaceutical operations were financing organized criminal and terrorist organizations, aid agencies wanted to ensure that they were purchasing high-quality drugs, and pharmaceutical manufacturers were eager to protect their brands. Each member (theoretically) brought unique perspective and knowledge to debates over difficult tradeoffs: how to improve track-and-trace technology while protecting patient privacy and how to extend customs inspections without stifling trade. It was an encouraging (if rare) example of consensus about an international problem and of a willingness to collaborate among actors that frequently disagree about the best way to get safe medicines to those who need them most.
The task force has made some important progress. It has called international attention not only to the commercial but also to the public health effects of counterfeiting. In its own words, IMPACT is necessary because “counterfeit medicines and other health products can have harmful effects on patients’ health.” It has emphasized that counterfeit drugs can plague developed and developing countries alike. “We knew there was the problem of counterfeits in medicine [prior to joining IMPACT],” says Otmar Kloiber, secretary general of the World Medical Association, an international organization representing physicians and an IMPACT partner. “But we saw it as a problem in the third world. This turned out to be a complete misperception. [Through IMPACT,] we came to see it as a problem not only of one area.”
IMPACT has articulated the need for countries to agree on an international definition of counterfeiting (to combat a problem, one must first identify it) and to impose stricter punitive measures where for decades there were few to none. Whereas punishment in many countries was once contingent on the likelihood that counterfeit medicines had caused death or serious injury (India and Argentina, among others), a discussion document circulated among IMPACT stakeholders catalogs a list of “aggravating circumstances . . . with the understanding that counterfeiting medical products is a serious crime . . . regardless of evidence of harm actually caused.” These aggravating circumstances, including the number of people affected, the opportunity for pecuniary gain, and the type of perpetrator (authorized operator, health professional, or repeat offender) would equip countries with a range of punitive options.
IMPACT has championed greater responsibility at all levels of the supply and distribution chains and has called on governments to adopt risk-based assessment protocols and invest more resources in enforcement. It has successfully practiced the international collaboration called for by its charter. In November 2008, the task force joined Interpol in directing a successful crackdown on Internet pharmacies peddling counterfeit pharmaceuticals in nine countries. According to a senior and well-placed U.S. government official, IMPACT and its leader, Valerio Reggi, have done an “excellent job” developing political awareness of the problem of counterfeit medicines. IMPACT has provided a global forum for dialogue and has offered “very useful model legislation” for countries. Although René Kappers, senior adviser for the European Generic Medicines Association, says the initiative is driven by companies and NGOs, it still “has been able to put the counterfeit issue on all national agendas.”
Indeed, the task force has won support among countries with significant drug-quality problems. At an IMPACT meeting in October 2008, Nigerian president Umaru Yar’Adua acknowledged that “no one country has all it takes to combat drug counterfeiting” and pledged to “woo” other African countries to play active roles in IMPACT.
Yet, the task force has also suffered from allegations of conflicts of interest from some other member states. Like most intergovernmental associations, it remains reliant on its member states to implement its recommendations. Its public health impact is limited by an exclusive focus on counterfeit drugs to the exclusion of substandard drugs more generally.
A Drug by Any Other Name . . .
Without question, drugs that have been “deliberately and fraudulently mislabeled with respect to identity and/or source”–as IMPACT defines a counterfeit–threaten brand integrity, cut into pharmaceutical company profits, and, over the long run, undermine incentives for investment in new and better drugs. They also threaten patient health if they contain too little or no active ingredient (as many counterfeit drugs do), have unlisted excipients (nonactive ingredients) that cause allergic reactions in unwitting patients, or have been produced under unhygienic conditions.
But from a short-term public health perspective, the fundamental issue is not willful misrepresentation but whether such misrepresentation jeopardizes patients’ health. Most of the world’s poor-quality drugs are not classified as “counterfeit” because “deliberate” and “fraudulent” misrepresentation can be prohibitively difficult to prove and because many poor-quality drugs are byproducts of ignorance or carelessness in manufacturing or distribution. In India, for example–rocked in recent months by allegations of poor manufacturing practice–official government data reveal that nearly 10 percent of drugs are substandard (other figures put the number as high as 30 percent), while less than 0.5 percent are considered “counterfeit.” Consider the implications: If 10 percent of diabetes drugs were of poor quality, approximately 3 million Indians would be treated with poor-quality medicines. If 10 percent of children with access to vaccines were given poor-quality ones, 8 percent of India’s children would go unprotected. When one considers only “counterfeit” drugs, these numbers drop to fifteen thousand Indians and less than 0.5 percent of India’s children, respectively. The devil is in the definition. Neglecting to address substandard drugs may significantly misrepresent the problem of poor-quality medicines.
In December 2008, IMPACT proposed altering how it defines a counterfeit, partly to address the thorny issue of intent. But the new definition may have little real effect–even if it passes amidst opposition from several powerful WHO countries, including India and Brazil–given its ambiguity and apparent contradictions. Presented to IMPACT’s executive board in late January 2008, the new definition labels a product as counterfeit if “there is a false representation in relation to its identity and/or source,” rather than if it has been “deliberately and fraudulently mislabeled with respect to its identity and/or source.” Although IMPACT says (in a footnote) that false representation is counterfeiting done “fraudulently and deliberately,” it also notes that “careless” behavior–not exclusively criminal intent–should be considered when determining penalties for counterfeiting. This seemingly expands the definition to include drugs that are rendered substandard because of lacking “good manufacturing practices” (GMP) or otherwise “careless” practice. Yet, in the same document, IMPACT cautions that “substandard batches or quality defects or noncompliance with GMP” should not be “confused with counterfeiting.”
There is a legal distinction to be made between a substandard drug that is the product of poor GMP and a counterfeit drug. One is the consequence of carelessness, the other of outright fraud. The punishment or prescriptive action demanded for each should be different, although in many cases the line between the two circumstances will be blurred. Criminal negligence, for example, would render substandard production “counterfeiting,” whereas mere carelessness would not. Monitoring and maintaining drug quality remains the responsibility of the inspectorates and enforcement agencies of individual member states, Kappers says. But while IMPACT recommends that member states pursue aggressive campaigns against counterfeits, it is notably silent about what, if anything, should be done to combat substandard medicines.
WHO did not always define the problem of poor-quality drugs so narrowly. In 1988, the World Health Assembly adopted resolution 41/16, which called on the director general of WHO “to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations.” In 1994, the World Health Assembly adopted resolution 47/13, which requested that the director general of WHO assist member states in their efforts “to ensure that available drugs are good quality, and in combating the use of counterfeit drugs.” Both resolutions were used as rationale for WHO’s Division of Drug Management and Policies and Action Programme Joint Project on Counterfeit Drugs (a predecessor to IMPACT), but the language changed: the project was designed to help countries assess their counterfeit drug problem and develop measures to combat it.
The 2006 Declaration of Rome clearly articulates IMPACT’s mission: to quash the criminal problem of counterfeit drugs. “Counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vile and serious criminal offence,” it states. Substandard production arising from GMP shortcomings is not included.
This lack of distinction between counterfeit and explicitly poor-quality drugs has led to some allegations of conflicts of interest. At the May 2008 World Health Assembly, “some delegates as well as several independent experts” called on member states to “critically analyze IMPACT and its activities, including conflicts of interests” among the pharmaceutical trade associations involved. At one point, a proposed IMPACT definition had included the word “history” (a drug for which there is “false representation in relation to its identity, history, and/or source”), prompting strident criticism that Western pharmaceutical firms might leverage this ambiguity to oppose the distribution of generic drugs. “The developed countries will succeed in creating new barriers to access by clubbing legitimate generics with counterfeits,” India’s drugs controller general, Surinder Singh, argued. The opposition Communist Party even demanded that India’s prime minister prevent Indian officials from attending the November 2008 IMPACT meeting in Bonn, Germany, in protest. At the meeting in Germany, IMPACT dropped the word “history” from the definition after only brief debate.
This critique is misguided. IMPACT’s definition would not limit access to legally produced generic drugs, only those claiming to be brand-name pharmaceuticals. In late 2008, IMPACT fell under heavy criticism that confusion over its definition was prompting European Union (EU) customs officials to seize consignments of Indian drugs en route to Latin America. Many of these drugs were under patent protection in the EU but not in the countries for which they were destined. In response, Hans V. Hogerzeil, director of essential medicines and pharmaceutical policies at WHO, reiterated that IMPACT “specifically excludes the misuse of the definition to exclude or hamper the trade in genuine approved generic products.” In its report on counterfeit medical products to the executive board, the WHO secretariat explicitly acknowledges that “counterfeiting of medical products does not always entail the violation of intellectual property rights” and that an “approach much wider” is needed. It urges member states to avoid resorting to trademark legislation when litigating counterfeit drug cases. The exhortation does not name any specific country but could well apply to Kenya, which in 2008 began considering legislation that would label generic versions of drugs “counterfeit” if they were under patent protection in Kenya–or anywhere else in the world. But IMPACT still pays scant attention to poorly manufactured, low-quality ones.
A Cause without a Constituency?
Since any substandard drug is a risk to health, why has IMPACT focused on overtly counterfeit medicines and excluded substandard ones? WHO and IMPACT correctly identify all substandard drugs as being worrisome, and in early discussions, the language reflected this. As rhetoric evolved and political realities became more obvious, however, the politically sensitive issues of substandard drug production and poor GMP were dropped. IMPACT’s stakeholders lacked the incentives to focus on substandard production, at least within an international WHO-led task force.
Innovator drug manufacturers have three reasons for combating counterfeits: First, they lose market share when counterfeit drugs (of whatever quality) replace their own. Second, confidence in their brands is undermined and sales revenue diminished if poor-quality knock-offs reach patients. Finally, counterfeits with too little active ingredient threaten the long-term viability of authentic drugs because they encourage the development and spread of resistance. Still, the companies’ focus is, with the exception of corporate social responsibility programs, primarily on their own high-value products–as any good, shareholder-accountable company’s would be. They have less incentive to combat poorly produced drugs aimed at other ailments or geographically insignificant markets. Some companies prefer to direct their efforts through partnerships with specific countries or through regional efforts, which are more closely tied to local country enforcement, rather than through a global task force.
Aid agencies, meanwhile, find themselves in a difficult situation: they want to distribute high-quality drugs but are also determined to treat as many people as possible. This may drive some agencies to buy the lowest-cost drugs available–in some cases without sufficient regard for whether the producers have passed all the regulatory hurdles demanded if the drugs were prescribed to Western patients. The Kenyan Ministry of Health awarded a multi-million dollar contract to Ajanta, an Indian drug company, to supply the antimalarial artemether lumefantrine drug Artefan in Kenya, even though this drug had not been approved by a stringent agency. The otherwise admirable Global Fund to Fight AIDS, Tuberculosis and Malaria encouraged this purchase, driven by the desire of a majority of its board members to procure drugs from developing countries at low cost. The company ultimately proved unable to supply sufficient quantities.
Developing-country politicians, too, want to ensure the high quality of drugs in their markets. But some may also have incentives to encourage and support the development of domestic drug manufacturing capacity. Local manufacturing can generate increased employment opportunities and more tax revenue–but also opportunities for lucrative bribes. Compromised politicians may be reluctant to introduce legislation–or support a task force–that targets producers operating with quality defects or noncompliance with GMP or good distribution practices, since this might undermine both legitimate revenue and illegal kickbacks. In January 2009, an article in Kenya’s Daily Nation reported than an unpublished Ministry of Health report “confirms what has always been known to be the biggest obstacle to a successful anti-malaria campaign–well-entrenched cartels of drug manufacturers and distributors working in cahoots with corrupt Health ministry officials to supply their own drugs.” According to the article, more than half of all malaria drugs in the country are not registered, a similar number are of poor quality, and most are “not recommended.”
Law enforcement agencies like Interpol are most concerned with halting trafficking in controlled substances and cracking down on counterfeit operations that finance terrorist networks. In both cases, they are especially interested in cases in which they will be able to make a strong legal case against the business or operation. While they might be interested in prosecuting criminally negligent firms, such cases are notoriously hard to make, especially if such companies are supported by local politicians.
In short, many of IMPACT’s primary stakeholders (pharmaceutical companies, aid agencies, governments, and enforcement agencies) have far more incentive to target the most obvious culprits (purveyors of good packaging but useless or worse products) than those that may be legal, tax-paying producers of substandard drugs. Many, if not all, of IMPACT’s stakeholders acknowledge the dangers of substandard drugs but say they represent “a different problem that requires a different name”–and, by extension, different enforcement.
What Can Be Done
Substandard drugs are difficult to combat. Identifying poor-quality batches requires widespread testing, which poor governments may be reluctant or unable to finance. Demanding manufacturer compliance requires both strict legal codes, which countries may lack, and rigorous enforcement, which many governments are unable or unwilling to perform. Ultimately, sustainable quality control requires each company to inculcate good techniques and production ethics, which can take decades. As a voluntary entity, IMPACT relies on member states to implement its recommendations. According to Dora Akunyili, vice chair of IMPACT, the initiative’s influence is limited because “we are not backed by international law. Right now, we do not have the teeth to bite.”
International consensus on what constitutes counterfeit and substandard drugs and on the appropriate legal and punitive redress could help encourage action in countries that have been slower to implement IMPACT recommendations. WHO should carefully consider its mandate–“the attainment by all peoples of the highest possible level of health”–and what that means for IMPACT.
IMPACT focuses mainly on legal breaches of intellectual property rights for medicines. It seems strange that it did not grow out of the World Intellectual Property Organization, the World Trade Organization, or some other trade-related body. One would expect that a WHO initiative would be most concerned with public health, which, in this case, means fighting poor-quality drugs of whatever stripe, “counterfeit” or just merely “substandard.” Instead, its admirable desire to combat poor-quality and dangerous medicines was tempered by its inability to criticize member nations (especially powerful nations with pervasive substandard production), and IMPACT turned its gaze to counterfeits alone. Although IMPACT should be commended for targeting counterfeit drugs, its narrow focus has neglected a large part of the problem.
Still, when considering legal and punitive redress, the task force should be careful to recognize the fine distinctions among patent infringement, mislabeling, and poor-quality drugs (although there can be overlap among these categories) and support evidence-based regulation. A discussion document outlining draft principles for IMPACT members demands an unprecedented level of government regulation of exporters–without demonstrating that this regulation will efficiently limit the production and distribution of poor-quality drugs. According to the draft principles, governments should have responsibility for ensuring that regulations on exported medicines meet the same standards as those for domestic products, except when the importing countries have less stringent requirements.
Such responsibility is without precedent. The United States, for example, does not appear to have a problem with exporting substandard drugs, even though most pharmaceutical drugs are categorized as EAR99, which means that no license is required for export (except in some cases in which the importing country is under sanctions for political reasons or for certain categories of controlled substances and pharmaceutical drugs). Demanding that governments monitor exports, while not without benefits a priori, shifts responsibility away from drug regulatory agencies in importing countries, as well as producers of drugs themselves. It also imposes higher costs on countries that already control quality in the absence of export restrictions. These countries will be required to conduct more testing and jump over more regulatory hurdles, even while countries with less-developed policing systems will likely be given time–up to a decade or more–to reform.
The discussion document also proposes unprecedented regulatory responsibility for actors at all levels of the pharmaceutical supply and distribution chain. It is prohibited to “own, possess or control counterfeit medical products in transit, trans-shipment, free-trade zones, bonded-warehouses and other situations of international commerce.” Under this standard, for example, Illinois-based Baxter International would have been held responsible for distributing tainted heparin in the spring of 2008, even though the U.S. Food and Drug Administration (FDA) concluded it had practiced reasonable vigilance.
A Call to Action
IMPACT would do well to articulate and agree upon a clear definition of the problem it seeks to combat, as well as sensible regulatory steps for member states. Punishment should be commensurate with the crime; sentencing should be more lenient for mistakes than for outright fraud. There are good reasons to combat the intellectual property infringements and criminality associated with counterfeit drugs. But one would hope that IMPACT, as a WHO-led partnership, would focus first and foremost on drug quality, regardless of the manufacturer’s intent. If it will not, it should acknowledge this and suggest that another entity do so.
Efforts to crack down on substandard production by improving GMP are already being made at the bilateral and nongovernmental levels. In October 2008, the U.S. Department of Health and Human Services announced that it planned to open FDA offices in China, India, Europe, Latin America, and the Middle East, pending the final approval of host countries. In November 2008, Shao Mingli, commissioner of China’s State Food and Drug Administration; Michael Leavitt, then-secretary of health and human services; then-FDA commissioner Andrew C. von Eschenbach; and then-U.S. ambassador to China Clark T. Randt Jr. officially opened the FDA’s office in Beijing. In October 2007, the nongovernmental organization U.S. Pharmacopeia (USP) opened a joint USP-China facility in Shanghai. Staff at the facility, conversant in Mandarin, Cantonese, and English, provide assistance to companies looking for technical, product, and service information. Between 2005 and 2006, the FDA, Peking University, and the International Society for Pharmaceutical Engineering cosponsored a training program on U.S. pharmaceutical regulation; guidelines for finished product; and active pharmaceutical ingredient manufacturing and quality control, including GMP, inspection regimens, and testing methods.
If it shifts its focus to substandard drugs, IMPACT can be a powerful advocate and convener for these activities. It can encourage other regional political and health groupings–such as the Pan American Health Organization, the Asia-Pacific Economic Cooperation, and the Association of Southeast Asian Nations–to build on its example with region-specific initiatives. Pragmatism in the face of WHO’s unfortunate political realities may have driven IMPACT’s decision to target only counterfeit drugs. But public health points to a new and broader role: to coordinate activities against all substandard drugs, which sicken or kill hundreds of thousands of people every year.
Roger Bate is a resident fellow at AEI. Karen Porter is a research assistant at AEI. Mr. Bate is the author of Making a Killing: The Deadly Implications of the Counterfeit Drug Trade (AEI Press, 2008).
1. International Medical Products Anti-Counterfeiting Taskforce (IMPACT), “Frequently Asked Questions,” available at www.who.int/impact/impact_q-a/en/index.html (accessed January 7, 2009).
2. IMPACT, “Counterfeit Drugs Kill!” May 2008, available at www.who.int/impact/FinalBrochureWHA2008a.pdf (accessed January 7, 2009).
3. IMPACT, “Frequently Asked Questions”; and World Health Organization (WHO), Executive Board, Secretariat, “Counterfeit Medical Products,” EB124/14, provisional agenda item 4.11 (December 18, 2008), available at www.who.int/gb/ebwha/pdf_files/EB124/B124_14-en.pdf (accessed January 23, 2009).
4. Otmar Kloiber, personal communication with the authors, January 12, 2009.
5. The Drugs and Cosmetics Act and Rules, as amended June 30, 2005, Parliament of the Republic of India, available at http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf (accessed January 23, 2009); and Matias Loewy, “Deadly Imitations,” Perspectives in Health 11, no. 1 (2007), available at www.paho.org/English/DD/PIN/Number23_article3.htm (accessed January 23, 2009).
6. IMPACT, “Draft Principles and Elements for National Legislation against Counterfeit Medical Products” (interregional meeting, ad hoc working group on medical devices, Bonn, Germany, November 25-26, 2008).
7. Medicines and Healthcare Products Regulatory Agency, “UK Medicines Investigators Take Part in International Operation to Tackle Illegal Internet Medicines,” news release, November 13, 2008, available at www.mhra.gov.uk/NewsCentre/Pressreleases/CON030988 (accessed January 23, 2009).
8. Anonymous senior U.S. official, personal communication with the authors, January 13, 2009.
9. René Kappers, personal communication with the authors, January 22, 2009.
10. “Yar’Adua Calls for International Coalition Against Drug Counterfeiting,” Africa News, October 31, 2008.
11. Many counterfeit drugs are also substandard.
12. See IMPACT, “Frequently Asked Questions.” IMPACT’s proposed revision of this definition, considered at WHO’s executive board meeting in late January 2009, would alter this syntax slightly–but with potentially powerful semantic effect, as discussed in this Outlook.
13. Suresh Sati (intellectual property investigator), Uday Shankar (Indian government hospital pharmacist), and Vijay Karan (former Delhi police commissioner), personal communication with the authors, January 16-17, 2009.
14. Government of India, Ministry of Health and Family Welfare, A Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs (November 2003), available at http://cdsco.nic.in/html/Final%20Report%20mashelkar.pdf (accessed January 23, 2009).
15. There are an estimated 60 million diabetics in India, but only 30 million are diagnosed. (“Novartis’s Ranjit Shahani: Patenting Innovation ‘Is Best Protection for Patients,'” India Knowledge@Wharton, May 15, 2008, available at http://knowledge.wharton.upenn.edu/india/article.cfm?articleid=4286 [accessed January 23, 2009].)
16. According to WHO, 80 percent of Indian children received the childhood measles vaccine in 2006. (WHO Statistical Information System, available at www.who.int/whosis/en/ [accessed December 8, 2008].)
17. WHO, “Counterfeit Medical Products,” emphasis added; and IMPACT, “Frequently Asked Questions.”
18. WHO, “Counterfeit Medical Products.”
19. René Kappers, personal communication with the authors.
20. WHO, Forty-First World Health Assembly, “Rational Use of Drugs,” WHA 41/16, committee A, second report, May 13, 1988.
21. Ibid.; and WHO, Forty-Seventh World Health Assembly, “The WHO Action Programme on Essential Drugs,” WHA 47/13, committee A, second report, May 10, 1994.
22. WHO, “Declaration of Rome” (International Conference on Combating Counterfeit Medicines, Rome, February 18, 2006), available at www.who.int/medicines/services/counterfeit/RomeDeclaration.pdf (accessed January 23, 2009).
23. “IP: Counterfeit Issue Stirs Debate among WHO Member States,” Third World Network (August 12, 2008), www.twnside.org.sg/title2/health.info/2008/twnhealthinfo20080802.htm (accessed January 7, 2009).
24. “Fake Drug Definition Change Urged by India,” Pharma Marketletter, October 21, 2008.
25. “New Call for India to Oppose IMPACT Move,” Pharma Marketletter, November 27, 2008.
26. Quoted in Lison Joseph, “Shipments Seizure: India’s Drug Makers May Avoid EU Route,” Mint (India), December 12, 2008.
27. WHO, “Counterfeit Medical Products.”
28. Joe C. Mathew, “Kenyan Cloud over India’s Pharma Exports to Africa,” Business Standard (India), January 11, 2009.
29. IMPACT, “Principles and Elements for National Legislation against Counterfeit Medical Products” (IMPACT General Meeting, Lisbon, December 12, 2007), available at www.who.int/impact/events/FinalPrinciplesforLegislation.pdf (accessed January 23, 2009); and WHO, “Counterfeit Medical Products.”
30. “The type of partnership that we find most effective is one with the enforcement authorities,” says a senior security officer at one major pharmaceutical company. “These partnerships can actually have an impact.” (Personal communication with the authors, January 21, 2009.)
31. Roger Bate and Karen Porter, “Quantity and Quality: An Rx for Efficient Drug Purchasing,” Health Policy Outlook, no. 8 (September 2008), available at www.aei.org/publication28642.
32. Gatonye Gathura, “Alert Over Low Grade Malaria Drugs,” Daily Nation (Kenya), January 4, 2009.
33. Otmar Kloiber, personal communication with the authors.
34. Dora Akunyili, “Cracking Down on Killer Drugs” (presentation, American Enterprise Institute, Washington, DC, April 14, 2008), available at www.aei.org/event1700.
35. U.S. Department of Commerce, Bureau of Industry and Security, “Introduction to the Commerce Department Export Controls,” available at www.bis.doc.gov/licensing/exportingbasics.htm (accessed January 9, 2009); and U.S. Department of Commerce, Bureau of Industry and Security, Export Administration Regulations part 732, “Steps for Using the EAR,” October 3, 2008, available at www.access.gpo.gov/bis/ear/pdf/732.pdf (accessed January 9, 2009).
36. IMPACT, “Draft Principles and Elements for National Legislation against Counterfeit Medical Products.”
37. When asked whether the contaminant could have been introduced at Baxter’s New Jersey plant, Janet Woodcock, director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, noted that “even in their own laboratories, with all their analytical equipment it took them a while to find out there was anything different or wrong with these heparin samples. So there are limitations to what inspections can tell you.” (Janet Woodcock [media briefing on heparin, FDA, Silver Spring, MD, April 28, 2008], available at www.fda.gov/bbs/transcripts/2008/heparin_transcript_042108.pdf [accessed January 23, 2009].)
38. State Food and Drug Administration, “SFDA Commissioner Shao Mingli Attends the Unveiling Ceremony of US FDA’s China Office,” news release, November 24, 2008, available at http://eng.sfda.gov.cn/cmsweb/webportal/W43879541/A64029155.html (accessed January 23, 2009).
39. USP-China, Quarterly Update (October 2007), available at www.usp.org/pdf/EN/aboutUSP/uspChinaQuarterlyOctober2007.pdf (accessed January 23, 2009).
40. Murray M. Lumpkin (deputy commissioner, International and Special Program, FDA), “Safety of Chinese Imports” (testimony, Committee on Commerce, Science, and Transportation, U.S. Senate, July 18, 2007).
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