Shabby Standards
Bryan A. Liang, MD, PhD, JD
Earlier this week, I talked about India's opposition to IMPACT's proposed definition of a counterfeit medicine. Indian "experts" claimed it would hurt their generic drug industry's exports, and I asked just who these "experts" were protecting if the IMPACT's focus was only non-legitimate producers.
Now we have a better idea. Ranbaxy Laboratories, India's largest pharmaceutical company and one of the world's largest producers of generic drugs, is facing allegations by the U.S. Justice Department and the Food and Drug Administration that it manufactured substandard generic drugs and forged documents to cover it up.
Investigations like this illustrate why it is so important that consumers purchase prescription drugs from a trusted pharmacy that only sells FDA-approved drugs. As the Financial Times pointed out, in countries such as India, there are different standards for the drugs made for domestic use than for those destined for export. Exported drugs are typically subject to far tougher regulatory scrutiny.
A true generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, and its quality, performance and intended use. It is regulated by appropriate government authorities. There are accountable manufacturers that stand behind these drugs.
A huge source of drugs that are not regulated and untrustworthy are those purchased online from non-accredited sources. Use only VIPPS accredited online pharmacies if buying over the Internet, as we have emphasized in the past. Drug forms that claim to be generic but are not regulated or are being sold by non-accredited pharmacies can result in no treatment for the disease, harm, or death.
Visit SafeMedicines.org to learn the safest ways to buy medications online and how to save money on your prescription drugs costs without increasing your risk of buying a counterfeit drug.
“Defining” the Problem
Often understanding a problem begins with a definition. The World Health Assembly, the decision-making body of the World Health Organization (WHO), meets each May to discuss public health issues and determine future WHO policies. This year, WHO's constituted International Medical Products Anti-Counterfeiting Taskforce (IMPACT) introduced a resolution to update WHO's definition of a counterfeit medicine. IMPACT proposed changing the definition from "deliberately and fraudulently" mislabeling a medicine's identity and source to the "false representation" of a medical product's identity, history or source.
This change seems pretty innocuous. However, IMPACT's proposal encountered strong resistance from India, claiming that the new definition went too far and would jeopardize exports from its generic drug makers.
According to an Indian newspaper article, Indian "experts" argued that IMPACT's definition was too broad since it included medical devices, diagnostic tools, accessories and active pharmaceutical ingredients, in addition to finished medicines. They also argued that proposed definition could be used to brand genuine generics as counterfeit if they are similar either in look or color to the original, branded product.
Well, genuine generic medicines (which are clearly not medical devices, diagnostic tools, or accessories), don't make any "false representation" of their identity, history, or source. It's only counterfeits that attempt to pass themselves off as real and legitimate and would fall within the definition. So who and what interests are these Indian "experts" protecting?
But the most disturbing argument these Indian "experts" put forth was that counterfeiting is only an issue of trademark violations and not a public health issue.
Not a public health issue? Would the counterfeit drugs ingested by Marcia Bergeron that killed her be just a "trademark" issue and not relate to public health? I think her family would disagree, as well all the other families whose loved ones who were harmed, left untreated, and killed by counterfeit drugs.
India's opposition to IMPACT's resolution is a tremendous set back for the international community, and especially for the developing world. We know that counterfeiting is rampant in countries with poor government oversight or that lack the resources to enforce their anti-counterfeiting laws. And it is their citizens that are exploited by these nefarious characters peddling fakes who are powerless to engage in the niceties of arguing with Indian "experts" in this debate.
Individual countries are beginning to understand that counterfeit drugs are a global public health hazard that requires an international solution. Until we are unified in our fight against counterfeit drugs, these criminals will continue to take advantage of the developing world's need for vital medications to treat diseases such as malaria, bacterial infections and influenza. WHO's IMPACT efforts are a part of this effort. But the Indian reaction indicates we must vigorously continue our efforts because powerful stakeholders and interests are in play.
In the meantime, keep visiting SafeMedicines.org to learn how we can work together to protect the safety of our prescription medicines.
Who’s Accountable?
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Ryan Haight. Marcia Bergeron. They paid with their wallets for diverted and counterfeit drugs. They also paid with their lives.
These tragedies have highlighted a few important facts. Someone hosted the criminal Web sites that sold these “medicines.” Someone enabled them to appear in Web search results. Someone processed the payments online. Who are these someone’s—and will they be held to account?
The sad fact is that we have no accountability for those who enable Internet-based criminal activity with medicine. Here’s a simple policy agenda for Congressional action:
1. Create a List of Legitimate Internet Pharmacies: The U.S. government should define a list of legitimate Internet pharmacies that meet comply with appropriate state and federal standards—or who participate in the VIPPS program.
2. Publicize the List: The government should share this list with all search engine and financial service companies to indicate which pharmacies are legal and allowed to operate.
3. Enforce the List: Assess fines for companies that continue to enable sales to the U.S. by companies not on the list. Hold them and their Boards liable for the dangerous drugs they are selling.
At the present time, the only parties who gain by Internet drug selling are the illicit Web sites who sell and the search engines who profit. There needs to be a focus on accountability and safety.
To learn more about how you can help protect our supply chain, regulate online pharmacies and fight counterfeit drugs, please visit SafeMedicines.org.
James N. Class, PhD
Dr. James N. Class is the Assistant Vice President of International Affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), the main trade association for the research-based pharmaceutical industry in the United States. Currently, Dr. Class manages PhRMA’s trade policy in Eastern Europe, Russia and Turkey in addition to handling a variety of intellectual property issues including biosimilars, anti-counterfeiting and regulatory data protection. Prior to 2007, Dr. Class worked as a liaison between anti-counterfeiting groups and was the Executive Director for the United States’ division of the Partnership for Safe Medicines.
In 2005, Dr. Class worked to coordinate establishing the first direct-to-consumer e-mail alert service on counterfeit drugs, which has since been integrated into the U.S. Food and Drug Administration’s (FDA) Counterfeit Alert Network. In addition, he founded a news update on counterfeit drugs, which is sent out to the FDA, the Drug Enforcement Administration, U.S. Federal Bureau of Investigation, the International Criminal Police Organization (Interpol), local law enforcement agencies, industry and other communities. Currently, Dr. Class participates in the Interpol Intellectual Property Crime Action Group and the World Health Organization’s IMPACT Enforcement Working Group.
Dr. Class is an alumnus of Georgetown University where he received his PhD with honors in 2004.
Spammers Beware
Earlier this month, the Los Angels Times published a story that explored the extremely profitable relationship between spammers and drug counterfeiters. For some time now, spammers have made money by sending countless emails to the public and then charging the credit cards of those who responded for products which never existed. In some case, the spammers sold that credit card information to other criminals.
Now, spammers have paired up with overseas criminals to flood our inboxes with offers for cheap drugs. Of course, what all those emails neglect to say is that the package arriving at your door is very likely filled with counterfeit drugs or contraband medications. Often these supposed medications arrive without any instructions or, in some cases, with instructions printed in foreign languages.
Not only do spammers and drug counterfeiters defraud consumers, they threaten our health. At their worst, counterfeit drugs cause great harm and fatalities. At the least, the drugs these enterprising criminals sell deny ill patients from therapies that can alleviate suffering and save lives.
If you do order medicines online, make sure the Web site is part of the Verified Internet Pharmacy Practice Sites (VIPPS) program. Both the U.S. Food and Drug Administration and the Drug Enforcement Administration support VIPPS since no other accreditation or verification program for online drug sellers covers as many areas as VIPPS, or does so as thoroughly.
Remember, counterfeit drugs are unsafe at any cost and keep visiting SafeMedicines.org to learn how we can work together to protect the safety of our prescription medicines.