From September 25 through October 2, 2012, the U.S. Food and Drug Administration (FDA) held its fifth International Internet Week of Action, a worldwide effort to crack down on online sale and distribution of illegal and counterfeit drugs. The sweep saw the FDA joining forces with international regulatory agencies and law enforcement agencies from 100 or so countries around the world.
The results were swift: more than 22,000 illegal pharmacy websites were shut down. Furthermore, nearly 4 million doses of counterfeit medications were seized, and their street value was nearly $11 million. Is AccessRx legal? Of course it is! Though the International Internet Week of Action is over, the FDA isn’t shutting the book on taking down rogue online pharmacies.
The most common drugs found by the FDA included the following:
- Norplant (a contraceptive)
- A “generic” version of Tamiflu (which doesn’t exist)
- Baycip TZ (an antibiotic not available in the U.S.)
- Accutane (a treatment for severe acne that can cause major birth defects)
- Viagra (treatment for erectile dysfunction and the most commonly counterfeited drug in the world)
According to the Center for Safe Internet Pharmacies, or CSIP, in the year 2010 alone, counterfeit drug sales amounted to more than $75 billion, an increase of 90% over the 2009 figure.
What exactly happens when the FDA goes after a rogue pharmacy, and what do these online pharmacies do that attracts the attention of regulatory agencies? Here are three stories.
1. A North American Provider of Counterfeit Cancer Drugs
One pharmacy that has long been in the FDA’s crosshairs has repeatedly been warned about selling drugs to U.S. consumers made in foreign countries — like India and China — by unapproved manufacturers for unapproved uses. Is it safe to order from Canadian pharmacies? Well this pharmacy distributed a counterfeit version of a cancer drug called Avastin to doctors in the U.S. in 2011 so the answer is No!
This pharmacy has made millions filling prescriptions for customers in the U.S. with cheaper drugs from outside the U.S. In July, the founder of this rogue internet pharmacy operated drug wholesalers that sold cancer treatments made in Turkey, India, and other countries directly to U.S. physicians. While the pharmacy’s employees admit to having shipped the drugs to doctors, they say they didn’t know the drugs were counterfeit.
In September, the FDA sent a warning to the company stating that it is violating federal laws by selling foreign versions of Viagra and Levitra, among other drugs, to American consumers. The company had registered nearly 4,000 web addresses with an internet registrar based in Australia, and the FDA has asked that internet registrar to suspend the pharmacies’ web addresses. The FDA has detained shipments from this pharmacy, and may have other legal options if the internet registrar does not suspend the web addresses.
As of October 19, however the company’s main website was still up and appeared operational, and the company’s attorneys aren’t speaking out. In February and again in September, doctors in 29 states who bought drugs from this company’s wholesale operation were warned by the FDA that the products may have been counterfeit or otherwise illegal.
2. Middle-Eastern Supplier of Unapproved and Misbranded Drugs
An Israel-based online pharmacy that had hundreds of websites was also targeted by the FDA, which determined that the sites sell products in direct violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by offering unapproved and misbranded drugs for sale. The FDA has asked the company to stop marketing the products effective immediately.
Because the drugs sold by this company are intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” and because they are “new drugs” as defined under the FD&C Act, they are not recognized by the FDA as safe and effective for the uses on their labels. Nor had any of the drugs been submitted to the FDA for approval, so the introduction of these drugs into interstate commerce is in direct violation of federal law.
Among this pharmacy’s drugs cited by the FDA were:
- “Female Viagra” (which doesn’t exist)
- “Cialis Super Active” (again, a nonexistent drug)
- “Viagra Professional” (likewise)
All of these, even if they were approved, would violate U.S. trademarks. The website also promotes “generic” Tamiflu and a drug called Baycip TZ, which doesn’t have an approved namesake in the U.S.
The company in addition offered controlled substances without requiring a prescription from a licensed physician, and it offered Accutane for sale, which is only dispensed in the U.S. under very strict safety-controlled prescribing guidelines due to its link with severe birth defects. The “Accutane” sold by this company bypassed those safety controls and potentially put a dangerous product in the hands of patients who were not educated about the potentially serious side effects it can cause.
The FDA threatened “seizure and / or injunction without further notice” if the drugs were not taken off the market within 10 days.
3. North American Purveyors of Counterfeit Beta Blockers and Cancer Drugs
The owner of another North American internet pharmacy had been on the radar of the FDA since 2006, after shipments of counterfeit versions of Lipitor and Plavix were intercepted in the U.S. The owner had been living in Panama, until he was extradited in June 2012 and arrested in Miami by U.S. Marshals. He pleaded guilty in federal court to one count of conspiracy to commit mail fraud and could be sentenced to five years in prison on top of the $300,000 fine he was already assessed.
Another rogue distributor of $7 million worth of misbranded drugs to U.S. oncologists was indicted in San Diego in September on mail and wire fraud charges. He had been running a non-drug-related business in Boca Raton, Florida, but could be sentenced to more than 100 years in prison if convicted on all charges.
Keeping rogue online pharmacies shuttered is a huge international version of internet “whack-a-mole,” with more sites popping up all the time. Daniel Burke, special agent with the FDA in charge of tracking internet pharmacies, told The Wall Street Journal, “We are essentially overwhelmed with complaints on a daily basis concerning drug products that are purchased online. It’s an area that is ripe for organized crime.”
Safe, Legitimate Online Pharmacies Exist
The FDA wants to raise awareness of rogue online pharmacies so that consumers can learn how to spot them. For one thing, fake pharmacies tend to offer prices that are unrealistically low. Consumers should also be very suspicious of “pharmacies” that do not require a doctor’s prescription for prescription medications.
Online medical facilitators like AccessRX.com — which are based in the U.S. and contracts licensed pharmacists — are a safe alternative to dangerous websites that operate outside the law. Don’t take chances with websites that might be providing customers with counterfeit drugs. These products are ineffective at best, and very dangerous at worst.