FDA should educate consumers about safe online pharmacies

posted Mon, 23 Apr 2012

For some time now, the Food and Drug Administration (FDA) has tried to dissuade consumers from buying prescription drugs from international online pharmacies. That’s why we were gratified to see the findings of a recent National Bureau of Economic Research paper. The study confirms RxRights’ longstanding position that drug importation through verified online pharmacies is safe and affordable.

Roger Bate, lead author on the paper, is an economist and fellow at the American Enterprise Institute, a conservative think tank. Bate is an expert in prescription drug safety and has advocated for drug importation from verified international pharmacies. His recent study found that, not only are prescription drugs from verified international pharmacies safe, they cost 52 percent less than drugs from U.S.-based online pharmacies. This isn’t the first time research has shown that international online pharmacies can be safe. And yet the FDA continues its nonsensical stance on importation.

“It is simplest for the FDA to make a blanket announcement,” explains Bate. It is technically illegal to import drugs, so it’s easy for the FDA to hide behind that. And I don’t think they are getting much pressure from anyone to change. The drug industry and the U.S. pharmacy associations are fully in favor of the law as it currently stands.”

Bate’s paper concludes that the FDA is doing Americans a disservice by generalizing that all online pharmacies are unsafe. Yes, there are rogue entities out there that pose as pharmacies and sell counterfeit products, but Bate shares our contention that consumers can be educated about how to choose a safe online pharmacy. “American consumers are more sophisticated than the FDA gives them credit for,” he says.

Bate has conducted extensive research and his forthcoming book, PHAKE: The Deadly World of Falsified and Substandard Medicines, is an exposé of substandard and counterfeit drugs in the developing world. He tested thousands of medicines from 17 different countries for the book. One of his shocking conclusions, “one out of every ten medications in emerging markets will not work as it should.” He found that it’s not uncommon for prescription drugs in places like India, China and Nigeria to be degraded, past their expiration date or outright tampered with to include a smaller amount of the active ingredient—and in many cases, no active ingredient at all.

Since many of these drugs are necessary for fighting life-threatening diseases like tuberculosis, AIDS and malaria, this is a grave problem. Bate estimates that 100,000 people die each year from counterfeit drugs. Though the book points out that Nigeria has made a great deal of progress on this issue in the last decade, at one point it was estimated that between 50-80 percent of the drugs available in Nigerian pharmacies were fake.

“We are lucky in the U.S. and Canada and Britain and the rest of the rich world,” says Bate. “We can generally be sure that 99 percent of our drugs are safe. In other parts of the world it’s a very dangerous thing to go to a pharmacy,” he says.

PHAKE includes a chapter focused on Internet pharmacies. Before conducting his research, and after all of the FDA and industry questioning of the safety of drugs bought over the Internet, Bate expected to find loads of dangerous drugs. But he didn’t. In fact, all of the drugs he tested from verified international pharmacies were authentic.

“Generally, the drug industry does a really good job in terms of combating counterfeiting,” Bate says. “It needs to be praised for that.” But Bate thinks that the industry is making a mistake when it comes to blacklisting all international pharmacies when so many people in the U.S. can’t afford their needed medicines. “Our prime consideration has to be with the patients first,” he says.

More worrisome than Internet pharmacies, is the fact that ingredients sourced from countries such as China and India aren’t strictly monitored, says Bates. In fact, 80 percent of the active ingredients in U.S. medications are imported from abroad. He makes an argument that stronger international policies are needed to protect against counterfeit prescription drugs. “Those are the kind of proactive things we need to be worrying about, not the credentialed Internet pharmacies that are selling the same Pfizer, AstraZeneca, Merck and other company products in Italy and Britain as well as in the United States and Canada,” he says.

Read a related New York Times opinion piece by Roger Bate.