Study: 44%-90% Of Medications Sold Over The Internet Are Counterfeit

According to a study by The International Journal Of Clinical Practice, between 44% and 90% of drugs sold over the the Internet are counterfeit.  The study focused on ED drugs and reviewed some fifty studies published in the past fifteen years.

[The Internet has] played a key role in driving the growth of counterfeit drugs, with studies suggesting that as many as 2.3 million ED drugs are sold a month, mostly without prescription, and that 44 per cent of the Viagra offered on the internet is counterfeit.

Affpower Sentencing

In what is the end of a long, long process, Michael Bezonsky formerly of RX Medical Networks and then of Affpower was sentenced last week in San Diego, California.  He received 70 months in prison for his activities in the Affpower matter.

I know Mike and like him.  I represented him in certain other matters so won’t discuss his guilt or innocence.  But he has many redeeming qualities and I wish him well.

Carrying Drugs Into The Country – II

In my last post on the subject, I discussed the FDA’s position that one cannot bring any drugs into the country.  In fact, as a matter of law, the FDA is absolutely correct.  There is no doubt that 21 U.S.C. 331 prohibits the importation of all drugs that are not labeled for U.S. distribution and prohibits all drugs that have not been approved for distribution in the U.S.  (The latter includes even drugs that are “equivalent” to already approved U.S. drugs if that specific manufacturer and plant haven’t been approved.)

Despite this, we know that travelers bring medicine over the border all the time.  This is because the FDA has established an official policy of non-enforcement for these entries.  Making matters murkier is the fact that the FDA has explicitly refused to define the edges of the permitted entries.

Extortion of online pharmacy buyers

The FDA reports that extortionists have taken over $30,000 from people who were first  induced to buy medicines online and then were contacted by fake federal agents demanding money.  The L.A. Times reports:

The Food and Drug Administration has received 75 to 100 reports nationwide recently of people receiving calls from individuals claiming to be FDA special agents or law enforcement officials, the agency said this week. The targets were told that buying drugs online or over the phone was illegal and that if they did not immediately pay their “fine,” they would be arrested, jailed or deported, the FDA said.

Several dozen people sent the money, usually through a wire service, to an address in the Dominican Republic, FDA spokesman Tom Gasparoli said. Most paid about $1,000 to $5,000, although some sent much more.

The number of reported victims is probably just the tip of the iceberg.

Two quick lessons:

1) When something is illegal, it’s always going to present creative opportunities for those who want to take advantage of the system.  Legalization and regulation help dry up those opportunities.  Overall, we may decide we still want it to be illegal.  But there’s always a cost involved.

2) If you believed the “federal agent” when he told you to pay a fine to the U.S. government but to mail it to the Dominican Republic, you probably should let someone else hold your wallet from now on.

Business as usual – No new drug importation under healthcare reform

Per the LA Times:

In a victory for President Obama and his allies in the pharmaceutical industry, the Senate today turned aside a bid by a bipartisan group of lawmakers to make it easier to import cheaper prescription drugs from Canada and Western Europe — a proposal that threatened to derail the Democrats’ landmark healthcare bill.

Like I said business as usual.

Carrying Drugs Into the Country – I

I recently finished a case involving a doctor who purchased drugs overseas and used them in his practice.  Over the course of dealing with internet pharmacy operators, I’ve learned about the laws regarding carrying drugs into the U.S.  But it wasn’t until this trial that I really experienced exactly how ridiculous this statutory scheme is.  I figured it would make a couple of interesting posts.

First off, the general rule is that a traveler can’t bring any drugs into the country at all.  It makes no difference if they’re prescription or not and it makes no difference if they’re subject to abuse or not.  You can’t bring aspirin from Vancouver.  As explained in the FDA’s “policy” (though it probably shouldn’t be flattered with that name):

The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not been manufactured in accordance with and pursuant to an FDA approval. Under the Act, FDA may refuse admission to any drug that “appears” to be unapproved, placing the burden on the importer to prove that the drug sought to be imported is in fact approved by FDA. Absent evidence that the specific drugs sought to be imported from a foreign country have been manufactured pursuant to an approved new drug application, in the manufacturing facility permitted under the application, such drugs would appear to be unapproved new drugs subject to FDA enforcement action.

One in Seven in UK has bought prescription drugs via the Internet

This according to The Sun:

A recent report revealed one in seven UK adults admits to buying prescription-only medication via the internet.

Operation Pangea – Global Crackdown on Counterfeit Drugs

According to the Washington Post:

NEW YORK — In highly orchestrated raids around the world this week, Interpol officers in Europe, drug agents in the United States and task forces from Sweden to Singapore hunted down counterfeit prescription drugs in an effort to stem a rapidly growing criminal business preying on financially pressed consumers looking for bargains.

FDA Warns Pharmacies

According to the San Francisco Chronicle:

The FDA sent 22 warning letters this week to ISPs, Web site operators and domain-name registrars seeking the shut down of 136 sites that sell drugs in violation of U.S. law.

Many of the sites would sell medication without requiring a prescription, said Karen Riley, FDA spokeswoman. Other violations included advertising drugs that were stated as FDA approved but have not been, Riley said.

No doubt about it, there are some bad actors out there

A (fairly) recent article from the Times in the UK focuses on the involvement of Russian criminal gangs in online pharmacies.

Sophos’s research discovered that in one of the most well-established affiliate networks operating out of Russia, called Glavmed, affiliate members can make $16,000 a day promoting pharmaceutical websites giving them potential annual earnings of £5.8 million. The criminals can be members of more than one affiliate network and some have boasted of earning more than $100,000 a day. Glavmed is associated with more than 120,000 fake drug websites, the majority branded “Canadian Pharmacy”, taking advantage of Canada’s reputation in the US, the biggest market for online medications, for cheap prescription drugs.