The Drug Re-Importation Re-Run: Not Worth Viewing

Here we go again. Although efforts to legalize prescription drug importation have consistently failed in the past, supporters are at it again. Now, a small group of federal senators is trying to attach importation to the Prescription Drug User Fee Act (PDUFA), which could amount to a poison pill that would kill an essential piece of bipartisan healthcare legislation. It is both bad policy and bad politics.

PDUFA was first enacted in 1992 in order to speed up the Food and Drug Administration's (FDA) review and approval process for new drugs, and it has been a success. Before PDUFA, the average time for approval was 27 months. Since then, that time has been cut by half, resulting in patients gaining access to life-saving drugs much more quickly. The legislation stipulates that pharmaceutical companies pay user fees to the FDA so the agency can afford the manpower needed for an expedited review process.

The process is not perfect, and the FDA must become more responsive and efficient to ensure new drugs in the pipeline get to market in a timely manner without sacrificing patient safety. However, there has been much good-faith negotiating over the past year by the FDA, industry, and other stakeholders, resulting in a bill that everyone can find acceptable. Drug companies get a commitment from the FDA to meet higher performance standards, FDA gets the funds needed to do its job,and, most important, patients waiting for new drugs to be approved won't have to wait as long. While not perfect, PDUFA is a win-win for all concerned.

Importation proponents argue that purchasing prescription drugs from countries like Canada is just as safe as purchasing them from U.S. pharmacies. Unfortunately, both the facts and recent history are not on their side. Drugs are cheaper in Canada because of government-imposed price controls, giving Canadians a free ride on American innovation. Conversely, drugs are more expensive in the U.S. because most of the R&D is done here, with nearly $50 billion spent by the industry last year alone. Given that it costs up to $1.4 billion to bring a drug to market and most drugs entering development never win approval (only 36 new drugs approved in 2011), it becomes clear that importing price controls would lead to a severe downturn in new drug development. And that's assuming that the mathematics of importation add up, which they don't: You don't need a Ph.D in economics to realize that Canada's pharmacies, serving 34 million people, could never supply a U.S. market ten times that size.

The safety argument falls just as flat: When you go to your local pharmacy or a VIPPS-registered U.S. online pharmacy to purchase your prescription drugs, you can rest easy knowing the FDA maintains the world's most stringent safeguards to protect the U.S. drug supply chain. Importation breaks a critical link in that chain, putting the safety of our patients in the hands of foreign governments. That's not only irresponsible, it's downright dangerous.

The simple truth is this: by allowing American citizens to import prescription drugs from other countries, the FDA has no way to guarantee their safety or authenticity.

There's a reason that criminals operating bogus online pharmacies overseas are clogging America's spam email folders with promises of cheap prescription medications: it's a profitable enterprise, especially because they tend to prey upon the elderly and the poor. The FDA and U.S. law enforcement agencies already have their hands full trying to shut down these websites. Legalizing importation would open the floodgates for even more dubious "pharmacies" looking to make a quick buck on an uninformed population.

And it's not just the pharmaceutical industry that has sounded the alarm on the dangers of drug importation. FDA Commissioners have cited safety concerns on multiple occasions, and current Commissioner Margaret Hamburg has said the FDA lacks jurisdiction over foreign supply chains. Case in point: many packages containing prescription drugs intercepted by federal inspectors found they were not manufactured in Canada, but in China and India. Such counterfeit drugs can be very harmful and even life-threatening to a patient.

There is just no way to guarantee that purchasing drugs from a foreign pharmacy, Canadian or otherwise, can be done without putting Americans at risk. The Senate must do the right thing, put our citizens' safety above flawed policy, and reject any importation amendments to PDUFA. The FDA already has a difficult job. Let's not make it harder by forcing the agency to regulate foreign governments that are beyond its control.