National, International Stakeholders Develop New Strategies for Fighting Counterfeit Drugs

Topics: Counterfeit drugs

Originally published in the May 2011 NABP Newsletter

“It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit,” said Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, in remarks at the Partnership for Safe Medicines’ Interchange 2010 conference held last October. Hamburg noted that “Estimates . . . vary a lot and we do need better surveillance and data to truly define the magnitude and scope of the problem. But what we do know is that it is growing every day.”

The scope and danger of the counterfeit drug problem gained additional attention from federal legislators and other stakeholders following a CBS 60 Minutes investigative report that aired March 13, 2011. In addition to presenting remarks from Hamburg and other government officials, the program gave an inside look at the bust of a counterfeit drug operation in Peru, stressing the deceptive appearance of the products, which closely mimicked authentic, brand-name drugs, and the unsanitary conditions of the location.

Many actions have been taken to address the counterfeit drug problem over the past two decades, initiated by both private organizations and United States government agencies, as well as international organizations and regulators. Yet, as Hamburg’s words suggest, the problem of counterfeit medications remains a serious threat to public health, and developed countries are not exempt. In the US and Europe, patients directly receiving counterfeit medications – which may include products with wrong ingredients, without active ingredients, or with insufficient active ingredients – via unscrupulous Internet sites operating illegally remains common. And the increasingly complex and international supply chain that includes global manufacturing raises concerns about adulterated ingredients infiltrating even well-controlled pharmaceutical markets.

The World Health Organization (WHO) notes that “the true extent of the [counterfeit drug] problem is not really known since no global study has been carried out.” Still, in the past, WHO has estimated that up to 1% of drug sales in developed countries may be composed of counterfeits. The figure remains much higher in the developing world.

In the US, rogue Internet drug outlets continue to be the most common avenue for counterfeits to find their way to patients. In NABP’s January 2011 Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators, the Association reported that about 96% of Internet drug outlets reviewed were not operating in compliance with state and federal laws or patient safety and pharmacy practice standards, a percentage that has remained fairly consistent over the past four years.

At the same time, the security of the legitimate supply chain has been strengthened as states have continued to improve regulation of drug wholesalers. Most states have increased regulation of wholesalers, and 22 states now recognize wholesaler accreditation by NABP’s VAWD® (Verified-Accredited Wholesale Distributors®) program; three of those states (Indiana, North Dakota, and Wyoming) require VAWD accreditation as part of licensure. While the drug supply chain is not impregnable – in a well-publicized case in 2009, for example, stolen insulin found its way back into the system and into patients’ hands – such breaches are comparatively rare.
But US regulators are not complacent about the security of the US supply chain. In her Interchange 2010 address, FDA’s Hamburg laid out a large part of the problem:

Today, nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients in the drugs on the American market come from overseas sources. . . the supply chain – from raw material to finished product – has become more complex and mysterious involving a web of repackagers and distributors in a variety of locations. Like any chain, the drug supply chain is only as strong as its weakest link, and the proliferation of additional handlers, suppliers and middlemen creates new entry points through which contaminated, adulterated and counterfeit products can infiltrate the drug supply.

Results include incidents like the deaths caused in 2008 by heparin that contained an adulterated ingredient, oversulfated chondroitin sulfate. At the Pew Health Group Conference, March 14-15, 2011, John Taylor III, Esq, acting principal deputy commissioner, FDA, stated that “another public health crisis like Heparin seems inevitable.” In combating such a global and complex problem, Hamburg noted, “[O]ur success or failure in this effort will depend on the relationships we establish and maintain with our foreign partners.”

International Stumbling Blocks

A number of stumbling blocks of varying magnitude make international cooperation on counterfeits easier said than done. Lack of legal and regulatory infrastructure in many developing countries form perhaps the largest blocks. WHO notes that only about 20% of its 191 member states have well-developed drug regulation, and 30% “either have no drug regulation in place or a very limited capacity that hardly functions.” According to WHO, few of its member states have enacted national legislation addressing counterfeit drugs, and weak sanctions against counterfeiters prevail, serving as little or no deterrent.

Disagreement between countries on the definition of “counterfeit drug” further muddies the waters, and makes it difficult to gather definitive global statistics on the problem. In short, do counterfeits include products that mimic brand-name products as closely as approved generics – even if they violate a patent? Or do they only include sub-standard or entirely fake medicines intended to defraud? Developed and developing countries are split on the answer. In developed countries, notably the US, counterfeits are intrinsically linked with intellectual property (IP) rights. (Indeed, much inter-agency coordination of the US government’s fight against counterfeit drugs is happening under the auspices of the Office of the Intellectual Property Enforcement Coordinator (IPEC).) Developing countries wish to separate the concepts. For example, WHO came under fire at the 2010 World Health Assembly from countries including Brazil, India, and Thailand, which disagreed with WHO’s working definition of the term “counterfeit” and urged WHO to step down from its role as secretariat of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which helps lead international efforts against counterfeiting. According to news reports, the dissidents felt that IMPACT had a hidden agenda to protect intellectual property rights of brand-name drug manufacturers even in countries with no effective IP rights, and was therefore going to endanger patients’ access to necessary drugs in the developing world. Although a preliminary report from WHO’s Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products was released in March 2011, containing recommendations intended to clarify WHO’s role to “ensure the availability of quality, safe, efficacious and affordable medical products” and “the prevention and control of medical products of compromised quality, safety and efficacy,” the issue remained unresolved heading into the 2011 World Health Assembly’s May meeting.

Progress

Among these difficulties lies consensus: All parties do agree that counterfeit medications are a major public health hazard throughout the world. And many countries demonstrate a growing will to tackle problems within their borders and to collaborate internationally. For example, the European Union is seeking to attack the sale of counterfeit drugs and to alert the public as to the dangers of purchasing unauthorized drugs over the Internet; the European parliament’s environment and public health committee voted to take measures to address criminal networks that exploit loopholes in existing controls. In late 2010, China announced a plan to increase its monitoring of Internet sites appearing in search results for counterfeit and illegal drugs, as part of a campaign to crack down on the trafficking and promotion of those products. The World Customs Organization, which represents customs administrations from 176 countries, last year signed the Chirac Foundation’s Cotonou Declaration, which calls for taking cooperative action against falsified or counterfeit medications.

Significant efforts to collaborate internationally and domestically have also continued within the US. Just in the last couple of years, FDA, the US Immigration and Customs Enforcement, and US Customs and Border Protection, among other federal agencies, have participated in a number of law enforcement actions in cooperation with other countries’ governments. These have included such actions as:

  • Operations Mercury (2009) and Mercury II (2010), which targeted the importation and distribution of substandard and counterfeit medications;
  • Operation Apothecary, frequent enforcement surges (12 in fiscal year 2010) at international mail and express carrier facilities, designed to address, measure, and attack potential vulnerabilities in the entry process that could allow smuggling of counterfeits; and
  • Operation Pangea III, a worldwide “week of action” targeting online sales of counterfeit and illegal medications and resulting in arrests around the world and the seizure of thousands of medications.

As noted by Victoria Espinel, the US intellectual property enforcement coordinator, in a White House blog post, Progress on the Intellectual Property Enforcement Strategy, one of these law enforcement sweeps also resulted in nearly 300 Web sites used to sell counterfeit drugs being taken down.

In yet another victory in the fight against rogue Internet pharmacies, Federal Bureau of Investigation agents arrested a Russian man who allegedly masterminded a botnet that sent billions of spam e-mails per day for counterfeit prescription medications and non-FDA-approved herbal remedies, among other products.

For the last year, coordination of federal efforts to combat counterfeit drugs in the US has fallen to IPEC. IPEC’s Counterfeit Pharmaceutical Inter-Agency Working Group released a report in March 2011 detailing strategic plans going forward and highlighting recent enforcement actions. (The report is available for downloading at www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf.)

One of IPEC’s emphases has been on encouraging increased private sector support for anti-counterfeiting measures, particularly in addressing rogue Internet drug outlets. Last December, IPEC announced significant private-sector cooperation in the form of 11 major Internet commerce companies planning to establish a nonprofit organization “dedicated to promoting information sharing, education and more efficient law enforcement of rogue Internet pharmacies,” now referred to as the Center for Safe Internet Pharmacies (CSIP). Information sharing would focus on spreading the word about rogue Internet sites selling pharmaceuticals in violation of federal law; as part of this effort, the organization would support an expansion or “White List” of NABP’s VIPPS® (Verified Internet Pharmacy Practice SitesCM)-accredited pharmacies. The IPEC educational piece would fund campaigns underscoring the dangers of purchasing drugs on the Internet from unauthorized pharmacies. To assist with enforcement, CSIP members would share information with law enforcement where appropriate, and also take such enforcement actions (when appropriate) as stopping payment or shutting down a site.

Prior to the IPEC meeting that initiated the formation of CSIP, NABP was able to announce progress in efforts to fight rogue Internet drug outlets. In the first half of 2010, three major Internet search engines limited their advertising to Internet pharmacies in the US that are accredited through NABP’s VIPPS program. Google subsequently filed a lawsuit against individuals who allegedly violated their new AdWords policy.

In her remarks at Interchange 2010, FDA Commissioner Hamburg discussed current and planned FDA activities to secure the US drug supply. The agency is developing risk models, she said, in order to target its enforcement efforts. FDA had already systematically ranked more than 1,000 active drug ingredients, she said, “in order of their respective risk of economically-motivated adulteration, based on a multi-factorial risk-based model.” A subset of high-risk ingredients would be subject to additional sampling and testing at the border. Hamburg also announced a new Drug Integrity and Security Program that would focus on threats to the supply chain. The program is intended to “take a life-cycle approach by identifying vulnerabilities for products and the supply chain starting with the raw ingredients, continuing through when the finished drug reaches the patient and, working with stakeholders, to put measures in place to mitigate these threats,” she said.

On a national and state level, law enforcement, regulatory bodies, nonprofits, and the media play an ongoing role in numerous anti-counterfeiting activities, from cooperating in investigations shutting down illegal Internet drug outlets, to helping stop licensees from participating in Internet drug outlet scams, to alerting the public as to safe Internet pharmacy usage.

Indeed, while the fight against counterfeit drugs may seem Sisyphean, momentum on both national and international fronts has been building. With hard work, cooperation, and ingenuity, public and private stakeholders can continue to make progress as they combat those who would jeopardize the public health with falsified, substandard medications.
 

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