FDA warns of fraudulent online pharmacies selling stolen, counterfeit drugs

Posted: January 19, 2014 Author: Jennifer Walker-Journey


Websites that illegally sell prescription drugs may not only be selling counterfeit medications and drugs with undisclosed ingredients, they could also put consumers at risk for non-health related issues such as identity theft, computer viruses, and credit card fraud, the Food and Drug Administration (FDA) warned.
The FDA is working with national and international regulatory and law enforcement agencies to crack down on illegal pharmacy websites, and wants consumers to be aware of these fraudulent companies when ordering medications online, particularly websites that claim to be Canadian pharmacies. In June, the agency announced that 1,677 illegal pharmacy websites had been seized and shut down. Many of the websites appeared to be operated by a criminal network that represented itself as various Canadian pharmacies.
The FDA warns that many of the medications sold by these illegal sites are often stolen or counterfeit. An unsuspecting consumer may be buying a medication that does not have the active ingredient that will make it effective, or it may have undisclosed ingredients that could endanger health or be life threatening to those taking the drug.
Consumers should be leery of pharmacies that allow them to buy drugs without a prescription from their doctor, offer deep discounts or cheap prices that seem too good to be true, send spam or unsolicited email offering cheap drugs, are located outside of the United States, or are not licensed in the United States.
Legitimate pharmacies typically always require a doctor’s prescription, provide a physical address and telephone number in the United States, offer a pharmacist to answer your questions, and have a license with a state board of pharmacy, the FDA said.

quoted from here 

Legislation to Allow Foreign Mail-Order Pharmacies to Dispense to Patients in Maine Poses Danger to Public Health, Warns NABP

March 20, 2013

Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world. Maine Legislative Document 449 proposes to amend the definition of the “practice of pharmacy” to allow mail-order pharmacies located in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and the European Union to dispense drugs to patients in Maine. In a letter (PDF) to Maine Senators John L. Patrick and Douglas Thomas, and Maine Representative Erin D. Herbig, NABP notes the concern that this action, by effectively circumventing the federally regulated United States medication supply chain, would open the door to unapproved, substandard, and counterfeit drugs and pose a significant risk to patient safety. The letter highlights the fact that medications dispensed by foreign mail-order pharmacies are not approved by the US FDA, or, in many cases, by any public health authority. Since such drugs are dispensed outside the tightly regulated US drug supply chain, there is no way of knowing whether the products are substandard, adulterated, contaminated, or even toxic. As indicated in the letter, the distribution of fake cancer medication purchased from foreign sources in February 2012 serves as a prime example. The Association also expressed its concern that the proposed legislation would condone and foster violation of federal law, placing residents of Maine who might use such mail-order pharmacies in jeopardy, both legally and from a public health standpoint. Organizations providing testimony in opposition to the proposed legislation included the Partnership for Safe Medicines and Rite Aid Corporation, and both entities presented NABP’s letter to Maine legislators.

Quoted from NABP located here

Large Shipments of Fake Drugs Seized by Federal Authorities From South Carolina Warehouse

March 20, 2013

Federal authorities seized $3.6 million-worth of counterfeit drug products from a warehouse in Columbia, SC. Fakes of medications such as Viagra^® and Cialis^® were shipped from India and stored in the warehouse for re-shipping, indicates the US Department of Homeland Security, Immigration and Customs Enforcement. South Carolina’s Secretary of State, whose office worked with federal agents during the investigation, told The State that he is happy the products are off the streets, and he stressed the health risks of using counterfeit medications.

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs By Jessica A. Ritsick -

To read this blog post, click here

Report: Common Action Needed Against Fake, Substandard Drugs

By Alan, on February 14th, 2013

(USA.gov)

A report from the Institute of Medicine, part of the National Academies in the U.S., calls for a new agreement on an international code of practice on drug quality to counter the growing health risks from illegimiate medicines. Among the recommendations in the report are a mandatory drug tracking system and tightening the licensing requirements on U.S. drug wholesalers.
Fake and substandard medicines not only fail to provide the protection or relief promised on the drug labels, says the report, they also can expose patients to dangerous medical conditions. An example is the recent case in the U.S. of a compounding pharmacy in Massachusetts that produced a medication that sickened more than 600 people and killing 44. In addition, fake versions of the cancer drug Avastin appeared in the United States in 2011 and 2012

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Kaiser Report: IOM Proposes State, FDA Actions To Stop Growth Of Counterfeit Drugs

Feb 14, 2013

The Institute of Medicine Wednesday urged a series regulatory changes to help protect the public against buying fake or poorly made drugs. Medpage Today: IOM: Work Needed On Counterfeit Drug Problem
State licensing boards should restrict their licensing activities to drug wholesalers who have been vetted by the National Association of Boards of Pharmacy (NABP) as a way of strengthening the nation's drug distribution system, the Institute of Medicine (IOM) said Wednesday. Also, FDA should establish a public database to share information on suspended or revoked wholesale licenses, the body suggested as part of its long list of recommendations. "Some states require NABP accreditation of wholesalers, but unscrupulous businesses can seek out states with lower standards for their headquarters," the IOM's "Countering the Problem of Falsified and Substandard Drugs" report stated. "And, because the wholesale trade is national, weaknesses in one state's system can become vulnerabilities in another” (Pittman, 2/13).

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NABP: Another Counterfeit Cancer Medication Distributed in US, FDA Warns

To read article dated 2/13/2013, click here

Despite new law, counterfeit medicines continue to penetrate the U.S. market

Edward C. Lawrence
While some progress has been made in addressing the inflow of counterfeit drugs into the U.S. with the FDA Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, there is still much more to be done. The recent news of fake anti-cancer drug Avastin has again put the issue of drug safety under the media spotlight. The latest estimates of counterfeit pharmaceuticals in the global market place the value between $75 billion and $200 billion a year. To put this issue in perspective, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs, which make up an estimated 15 to 30% of the market. Furthermore, this black market reduces government revenues by 2.5 to 5%. Even though high safety and regulatory standards in the U.S. have traditionally kept fake drugs below 1% of the total national pharmaceutical market, the percentage is expected to rise as improving technological sophistication allows counterfeiters to exploit potential shortcomings in the supply chain.

The recent Avastin case is not the first time a complex medication has been counterfeited. In 2008, Chinese subcontractors for Baxter International’s injectable blood-thinner heparin substituted the active ingredient with a cheaper, toxic substance. 

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Counterfeit Prescription Drugs: How to Protect Yourself

by Rhona Finkel on December 5, 2012

The World Health Organization defines a counterfeit medicine as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."
Counterfeit medicines are defined broadly throughout the world by the World Health Organization. On April 1-3, 1992, experts from the world over met in Geneva for the first international meeting which gathered together member states and other organizations, such as INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16)."
The number of counterfeit drugs continues to grow. According to SafeMedicines.org, counterfeit drugs have killed an estimated 700,000 people from malaria and tuberculosis alone.
Up to a third of all anti-malarials are suspect, and around 10% of all essential drugs in emerging markets fail basic quality tests.
No country is safe. India is the world’s largest manufacturer of generic drugs, but it’s estimated that from 12-25% of their supply might be contaminated with substandard or counterfeit medicines. The WHO reports that many of those medicines find their way to Africa, where some nations may have up to 40% of their drug supply contaminated.

Which drugs are most commonly counterfeited?

Here in the U.S., certain drugs are more likely to be counterfeit.
Cardiovascular Medications
Cardiovascular drugs are for a serious need, one which many Americans turn to foreign drug-makers for. But, points out Haiken, the danger isn't that the Americans won't get the medications--rather it's that they will get a dangerous counterfeit instead.
Antibiotics
Of course a counterfeit version might very well not heal you--but it could also make you sicker, as fake meds can be tainted with heavy metals or some other dangerous ingredients.
Cancer Drugs
Fake cancer drugs have been found in both Israel and China--and just February of this year in the U.S. In fact it's possible that doctors' offices and clinics might have bought counterfeit Avastin, containing no real drug, but rather acetone and water.
ED Medications
The Pharmaceutical Security Institute reports that 37% of all fake medicines seized are ED drugs. ED drugs are offered for sale via thousands of fake online pharmacies without prescription requirements. Writes Ms. Haiken, "The real danger of buying these drugs from a non-VIPPS approved pharmacy is that there is a very good chance they will not just be counterfeit, but poison."
Treatments for Chronic Ailments Like HIV, Diabetes & Alzheimer’s
Because chronic ailments respond slowly to treatment. it's hard to know if the drugs are really fake.
Psychiatric Medications
A Google search for Xanax, Ativan, Adderrall, or Ambien reveals hundreds of websites offering these powerful drugs without a prescription.
It is a dangerous world out there, and one where you have to keep your senses about you, since the matter can very easily be the difference between life and death.

Common Sources of Counterfeit Drugs

India and China are most commonly the source of counterfeit drugs. Havocscope, which keeps track of counterfeit medicines worldwide, found that genitourinary medicines, anti-infective drugs, and central nervous system drugs are the most frequently counterfeited kinds of medications. Just this August, according to Scientific American, "$182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China."
Dr Sneh Khemka, Bupa International's medical director, notes that so many of the world's counterfeit medicines come from Asia, particularly China, that it is a dangerous area when you're searching for medical purity. Khemka writes that across the country between 50-85% of some drugs are fake and kill up to 300,000 people per year, which is the equivalent of wiping out the entire population of Iceland every year.
Don't think you're safe if you buy your drugs in any other country, however.
According to the CBS news, the FDA found in April 2012 that a counterfeit version of Roche’s Altuzan (bevacizumab), an injectable cancer medication, contained no active ingredient.
In an article entitled “Fake pharmaceuticals: Bad medicine,” in October 13, 2012's, issue of Economist, the authors determined that Pfizer found 20 counterfeit versions of their drugs in 81 countries in January 2009, and by July 2012, Pfizer reported finding 60 of their counterfeit drugs in 106 countries.
Create.org in a whitepaper on health and safety risks of counterfeits asserts that up to 40 million U.S. prescriptions are filled each year with counterfeits.
"Pharmaceutical counterfeiting is a low-risk, high-profit criminal enterprise that attracts entrepreneurs and organized criminals," says John P. Clark, vice president and chief security officer for the drug company Pfizer. "What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune."
In September/October, Computer World reported, an Interpol operation involving 100 countries seized $10.5 million worth of counterfeit drugs. Nearly 18,000 websites selling fake drugs were shut down during the operation, and 3.7 million doses of counterfeit drugs were seized.
Despite the way counterfeit drugs have encroached upon the U.S., CBS news points out that most of the ingredients in fake American medicines still come from other countries, including China and India, which are known to have weak regulatory systems. The FDA only inspects about 12% of overseas facilities a year.

How to know Whether Your Prescription Drugs are Counterfeit

The World Health Organization estimates that over half the drugs sold online via websites that hide their physical address are counterfeit. Writes the WHO:
"Criminal organizations manufacture these counterfeits, not in quality-controlled laboratories, but in hidden rooms with unsanitary conditions. And instead of patented ingredients, these meds can contain a haphazard mix of chemicals and fillers like highway paint, floor wax and boric acid — ingredients and doses that can actually harm you and your family."
It is a serious problem, one which the Department of Justice recognizes poses great danger, and the government recognizes that they need help--our help.
Attorney General Eric Holder launched a massive public education campaign, calling for help from all corners, from the TV, the radio, the newspapers, and blogs."
Because the government can't stop the onslaught alone, in his public campaign, Holder has asked that all Americans be proactive when buying their medications.
He strongly encouraged online-prescription-buyers to follow these tips to avoid counterfeit and possibly harmful products, and these are his warnings verbatim:

1. Don’t buy drugs from sites that sell prescription drugs without a prescription from your own physician.
2. Consult the National Association of Boards of Pharmacy, which maintains a list of accredited online pharmacies" [to be sure that the pharmacy from which you're buying the medication is valid].
3. If using an online pharmacy, make sure it has a legitimate brick-and-mortar street address, as well as a pharmacist on duty and available.
4. Discard the medication if it is of a different size or color, or if it has a different or odd-looking brand insignia from the medication you are used to taking.
5. Discard the medication if it dissolves differently or badly or has a strange or bitter taste that you are not accustomed to.
6. If you suspect a website is selling counterfeit meds, report it here.
7. And for more info on buying medicine on the Internet, go to fda.gov/ForConsumers/ConsumerUpdates or nabp.net/programs/consumer-protection/buying-medicine-online/counterfeit-drugs/.

By following these simple tips suggested by the FDA, you can help ensure that the medication your family buys online is what it claims to be."
A new technology may aid in tracking down counterfeit medications. This September, the Food and and Drug Administration unveiled the Counterfeit Detection Device #3 or CD3.
Battery-operated, the machine can emit up to 10 different wavelengths of ultraviolet and infrared light and can be used on capsules, tablets, powders, and packaging like inks, papers and covert markings. It's also capable of detecting products that have been tampered with, re-labeled, or re-glued. It has already analyzed nearly 100 counterfeit products, finding counterfeits masquerading as Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singular, Plavix, and Wellbutrin.

Protecting Yourself

Huffington Post has a few ideas. Know that Pfizer has partnered with the National Association of Boards of Pharmacy® (NABP) and several other organizations on a YouTube channel, SpotFakeMeds, that allows consumers to hear firsthand from anti-counterfeiting experts about what to look out for and how to buy online safely.
Despite the threats posed by counterfeit medicines, it is possible to safely purchase legitimate, FDA-approved prescription medicines online if you keep your eyes open. For example, one way to purchase your meds if you have a valid prescription is to ensure that you are buying from a legitimate site. All legitimate sites receive VIPPS® (Verified Internet Pharmacy Practice Sites) accreditation from NABP, which indicates one can find there FDA-approved medications for purchase. A list of VIPPS-accredited pharmacies can be found on the NABP website, www.AWARERx.org.
Dr. Sneh Khemka, publishing on Bupa International, runs through some clues to a counterfeit pill:

• Spot the difference. Is the lettering on the packaging hazy and printed flat (rather than raised), or is the expiry date missing?
• Read carefully. Are the labeling and patient information in a language you understand? If there are misspelled words, contact the manufacturers – it can be a telltale sign.
• Use your senses. Is the medicine the same size, shape, texture, colour and taste as your previous prescription?
• Feel for consistency. When you handle the drug does it fall apart easily? If so, it could signal a fake.
• Do a price check. Does the cost of the drug seem very cheap in comparison with your official provider? If it’s much lower, it could be a scam.

Now, let's say you're buying the medicine online--what should you keep a close eye out for?

• Prescriptions. Make sure the website you buy from requires a prescription and has a pharmacist you can contact for questions.
• Licensing. Only buy from certified online pharmacies. Search the website for a declaration of authenticity or certification and double- check this with your country’s official drug regulatory agency. For example, pharmacies in the UK that are registered with the Royal Pharmaceutical Society of Great Britain can display a logo on their website.
• Security. Don’t supply any credit card numbers unless you are sure the website has policies in place to protect your information and has a secure online payment system.
• Promises. Statements such as ‘no risk’ and ‘money-back guarantees’ can be key giveaways of a counterfeit website.

In short, if the way you're getting your medicine seems just too good to be true--then it very likely is, and the dangers of buying your medicine that way are manifold. It is in your own greatest interest to make sure that the drugs you are buying are indeed what they advertise themselves to be--and are not chemicals that create even more problems than they claim to address


Source: Counterfeit Prescription Drugs: How to Protect Yourself - Drugsdb.com http://www.drugsdb.com/blog/counterfeit-prescription-drugs.html#ixzz2GXn3Z6VG

FDA Warns Against Unapproved Drugs From Foreign Suppliers

Dec 21, 2012

More than 350 medical practices in the United States may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier, the US Food and Drug Administration (FDA) warned on its Web site this week.
"These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the agency said.
The FDA has sent a letter to the physicians or medical practices involved informing them of the situation.
A list of the doctors and clinics that received the letter is available here.
Products Not FDA Approved
To reduce the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, the FDA is asking that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.
"Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses," the FDA said. Medications not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use, the agency reminds clinicians.
So far in 2012, the FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers 5 times: on February 10, April 5, April 23, June 28, and September 10.
The FDA is asking healthcare providers to examine their purchasing practices to ensure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States.
"Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them," the FDA said.
Healthcare providers are asked to report suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web site.
The FDA has provided information on its Web site on how to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business.
Adverse events related to the use of suspect medications may be reported to MedWatch, the FDA's safety information and adverse event reporting program, either online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Source found here

FDA Fights Web Pharmacies Selling Unapproved Drugs

posted: Oct 05, 2012 3:55 PM CDTUpdated: Oct 05, 2012 3:55 PM CDT

WASHINGTON (AP) -- The Food and Drug Administration is stepping up its fight against counterfeit and other potentially harmful medicine sold over the Internet.

The agency is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.

The FDA has sent warning letters to three companies behind most of the websites. It's also seized some illegal medicines, filed civil and criminal charges against companies and people, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.

Those efforts are part of a global crackdown on online sellers of counterfeit and illegal medical products. Interpol, the international police agency, says about $10.5 million worth of medicines were seized worldwide last week and more than 18,000 illegal pharmacy websites were shuttered.

Source found here

 

Call for counterfeit drug treaty gets group banned from WHO event Read more: Call for counterfeit drug treaty gets group banned from WHO event - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/call-counterfeit-drug-treaty-gets-group-banned-who-event/2012-11-15#ixzz2CSBi3jgw Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

November 15, 2012 | By Eric Palmer

The World Health Organization (WHO) is banning a group of doctors and academics who are calling for a global treaty on counterfeit drugs from attending an international meeting on the problem, and India may have been the country that nixed them from speaking at the meeting in Argentina.

According to Reuters, the group published a paper Wednesday in the British Medical Journal calling for a treaty like those used for money laundering and human trafficking that they say can slow the appearance of counterfeit drugs and save lives. They contend that without a treaty there is no official means for regulators and law enforcement to work across borders, providing havens in which counterfeiters can operate.

Amir Attaran of the University of Ottawa in Canada, the lead author of the article, told Reuters that the WHO notified him Monday that he and his colleagues were not welcome after India objected. He called it a "scandal." WHO wouldn't tell Reuters who was behind the objection and the service couldn't reach officials in India.


Read more: Call for counterfeit drug treaty gets group banned from WHO event - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/call-counterfeit-drug-treaty-gets-group-banned-who-event/2012-11-15#ixzz2CSBqTPpY
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FDA shoots warning across bow of CanadaDrugs.com Reports tie Internet drug company to FDA's probe of counterfeit Avastin Read more: FDA shoots warning across bow of CanadaDrugs.com - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-shoots-warning-across-bow-canadadrugscom/2012-10-02#ixzz28CzxTTp8 Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

October 2, 2012 | By Eric Palmer

The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.

The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women.

A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.

An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.

The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.

Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions

Dr. Margaret Hamburg, FDA Commissioner, delivering the keynote address at the 2012 Interchange. Image courtesy of C-SPAN. Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines

.S. FDA Commissioner Hamburg Urges Physicians, Patients to Only Purchase Medicines from Reliable Sources to Better Protect Against Fake Drugs
Washington, D.C. (September 28, 2012) – The Partnership for Safe Medicines (PSM) today convened leading domestic and international stakeholders in the fight against counterfeit and substandard medicines, making a renewed commitment to work together and implement new solutions to protect patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg, in a keynote to the conference, highlighted new efforts her agency is undertaking to reduce the threat and pledged the FDA’s ongoing support to ensure a safe U.S. drug supply.
"The American people have every right to expect that the medicines they rely on are exactly what the package and label say they are – and that the medicines have been carefully evaluated by FDA for safety, efficacy, and quality," said FDA Commissioner Margaret A. Hamburg, M.D. "Our success in addressing this global challenge will depend on collaborating with public health and regulatory partners here in the United States and around the world."

PSM Executive Director Scott LaGanga.
Image courtesy of C-SPAN.

The event brought together more than 140 participants, representing government, health care, law enforcement and patient advocacy. This is the third year that PSM has hosted a global Interchange event in Washington, D.C.
“This year’s Interchange was our boldest, most ambitious effort to date,” said PSM President Dr. Marvin D. Shepherd. “By bringing together stakeholders from as far away as India and Great Britain to share information and ideas on how to win the war on counterfeit medicines, we are sending a message to counterfeiters worldwide: the noose is tightening, and you can’t hide forever. As regulators and law enforcement agencies in the U.S. and abroad come to grips with the great public health risk of fake drugs, our efforts and successes will only intensify in the future.”  To read more click here

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

In this Forbes opinion piece, John Lechleiter, president and chief executive officer of Eli Lilly and Company, examines the business of counterfeit medicines, writing, "With global sales last year estimated as high as $200 billion, counterfeit medicine is big business, and it's growing." "In a recent Forbes column, Henry I. Miller cited an estimate by Roger Bate of the American Enterprise Institute that more than 100,000 people die every year from counterfeit drugs," he continues, adding, "That's why fighting counterfeits is essential to safeguarding health. We need action -- national and international -- to better secure the pharmaceutical supply chain." To read remainder of article click here.

Role of the pharmacist in preventing distribution of counterfeit meds - American Pharmacists Association

American Pharmacists Association - Article March 24, 2012: - Role of the pharmacist in preventing distribution of counterfeit meds

"Summary: The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer.

Conclusion: The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring."

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Canadian Operator of Internet Drug Outlet Indicted for Distribution of Fake Drugs to US Consumers

From the National Association of Boards of Pharmacy website:
June 27, 2012 01:15 PM

Andrew J. Strempler, a Canadian citizen, was arrested by United States officials in Florida and faces charges relating to his operation of a Web site selling drug products to US residents including distribution of counterfeit and non-Food and Drug Administration (FDA)-approved drugs. “According to the indictment, from around January 2005 through June 9, 2006, Strempler and his co-conspirators unlawfully enriched themselves by selling prescription drugs to individuals in the United States, falsely representing that RxNorth was selling safe prescription drugs in compliance with regulations in Canada, the United Kingdom and/or the United States. The indictment further alleges that Strempler obtained the prescription drugs from various other source countries without properly ensuring the safety or authenticity of the drugs. In fact, the indictment alleges that some of the drugs sold by Strempler included counterfeit drugs,” indicates a press release from the US Attorney’s Office, Southern District of Florida. Strempler faces one count of conspiracy to commit mail fraud and wire fraud, in violation of Title 18, US Code, Section 1349, and two counts of mail fraud, in violation of Title 18, US Code, Section 1341. The government is also seeking forfeiture of $95 million.

Wifredo A. Ferrer, US attorney for the Southern District of Florida stated, “FDA regulations are designed to promote and ensure the safety and integrity of prescription drugs sold and used in the United States. The US Attorney’s Office is committed to assisting the FDA enforce these regulations to protect American consumers from unsafe, adulterated and counterfeit drugs.” David W. Bourne, special agent in charge, FDA, Office of Criminal Investigation (OCI), Miami Field Office, stressed that the FDA OCI is committed to “aggressively pursuing individuals” who seek to sell counterfeit, adulterated, and misbranded drug products to US consumers via the Internet. Strempler appeared in federal court on June 14, 2012, before US Magistrate Judge John O’Sullivan. If convicted, Strempler faces a possible maximum statutory sentence of up to 20 years in prison on each count.

Additional details about the charges against Strempler are available in the US Attorney’s Office press release. The indictment (PDF) is available for download from the Department of Justice Web site. The press release notes that an indictment is only an accusation and a defendant is presumed innocent until proven guilty.