Congress urged to curb rogue online pharmacies

August 14, 2011

Advocates are hoping for a new push in Congress to control rogue online pharmacies, according to Bryan A. Liang, professor at the University of California, San Diego, School of Medicine and vice president of the Partnership for Safe Medicine.

Advocates are hoping for a new push in Congress to control rogue online pharmacies, according to Bryan A. Liang, professor at the University of California, San Diego, School of Medicine and vice president of the Partnership for Safe Medicine.

New legislation needed

At a June Capitol Hill briefing, Liang said that the time is ripe to pass legislation mandating that pharmacies be certified to sell on the internet and suggested that the “VIPPS” certification program of the National Association of Boards of Pharmacy would be appropriate for that purpose.

He also called for new legislation mandating that with each internet search for online mediations, a banner should appear stating that selling drugs over the internet by noncertified outlets is illegal. The banner should then point consumers to information on certified sites.

Although legislation has not yet been introduced, he said it’s possible that it could move in Congress before next year’s elections. “This is the first administration that has taken this issue beyond just simply identifying it,” Liang said. “It is trying right now to enter into a world where we are going to cooperate globally.”

Manufacturing concerns

Also at the session, Ilisa Bernstein, PharmD, JD, FDA director of pharmacy affairs, said, “What we see is a lot of counterfeit, diverted, stolen, and otherwise unapproved products that have harmful ingredients - too much, too little, the wrong ingredient, maybe expired.” There are also many products made under filthy conditions, she said.

According to Bernstein, FDA looked into 72 criminal counterfeit drugs last year - the most in a year - and most of the sellers in those cases had an internet link.

“The number of drugs that are coming into the United States is astounding,” Bernstein said. “There are so many, they can’t be counted, and they certainly can’t all be examined.”

In a study of more than 2,000 packages of drugs ordered over the internet, the agency found that more than half had a generic form available in the United States. Studies show that generics in the United States are less expensive than elsewhere, Bernstein said.

“So why is this happening? One of the theories, we think, is because people are using the internet to get drugs without a prescription … they are self-medicating.” That’s a frightening prospect, she noted, in light of the fact that the packages FDA searched included drugs such as warfarin, with its requirement for blood tests; amoxicillin, with its risk of causing drug resistance; and dipyrone, an analgesic removed from the U.S. market in 1977 because of its serious adverse effects.

Education campaign

Because of the difficulty in targeting the many websites, said Bernstein, a key element of FDA’s strategy will involve educating consumers and health professionals about the dangers of buying online.

The agency is undertaking an effort to look at why people are buying online and to decide what messages will most effectively change that behavior. It hopes to work with other entities to develop communication materials, although, she said, that initiative will depend on funding.

Although FDA posts information at its website, Bernstein said, “People aren’t going to come looking for us. We need to actually push this information out to the right people at the right time.”

A global problem

Liang pointed out that websites can go up anonymously and come down within hours. Law enforcement is based on nations’ sovereignty, making it difficult for authorities to do anything about the issue.

The problem is global; online pharmacies exist everywhere, but nations don’t have a global solution, Liang said. There are no global government treaties or top-level U.N. efforts seeking to understand what is happening and develop a standardized way of approaching it.

While there is an international treaty for postal regulations in effect that actually impedes enforcement, Liang said, no treaty addresses online drugs ordered through the mail.

The postal angle

Less than 1% of packages coming into the United States are inspected by Customs and Border Protection, Liang said. If a package isn’t inspected within roughly 24 hours of being pulled aside, according to U.S. Postal regulations it must be sent on.

If FDA does inspect the package, international postal regulations require it to give recipients a chance to say that the package is legitimately theirs, said Liang. Often no one does that, and often FDA has to send the package back to the sender, which allows illegitimate sellers to sell it again.