As rising prescription drug prices continue to cause controversy, a pair of lawmakers is asking the Obama administration to expand the legitimate importation of medicines from Canada.
Under a 2003 law, the Food and Drug Administration is allowed to issue waivers for individuals to import pharmaceuticals for personal use. But importation is not otherwise permitted until the US Health and Human Services certifies the importation would not pose a health risk and could lower consumer costs.
So Chuck Grassley, a Republican senator from Iowa, and John McCain, a Republican senator from Arizona, have written HHS Secretary Sylvia Burwell to certify that importation is viable, at least when prices are rising and there is a lack of competition. They note that many drugs that have been “subject to drastic prices increases” are available outside the United States at a lower cost, according to their letter.
They don’t offer examples, but one medicine that comes to mind is Daraprim. Martin Shkreli’s Turing Pharmaceuticals last summer bought the 63-year-old, life-saving, anti-infective and quickly raised the price from $13.55 a pill to $750, a 5,000 percent increase. And Turing prevents generic competition through a closed distribution system, which has prompted antitrust probes.
However, GlaxoSmithKline sells a version of the drug in other countries. The drug changed hands a couple of times before Turing purchased it. But as the senators note, there have been several instances in which the original manufacturer of a drug will sell the rights to make or market a drug in the US, and then continue to sell the drug abroad. The “pattern is true of many drugs” for which prices jumped, they wrote.
The Glaxo drug, by the way, sells online for as little as $1.72 a pill, according to PharmacyChecker.com, which evaluates and verifies online pharmacies.
Although they acknowledge it would be difficult for HHS to certify that importation of all drugs from Canada are safe, the senators believe the department could do so in a “targeted manner” and still meet safety standards, according to their letter.
So they want HHS to permit importation when a drug meets each of four criteria: It has lost patent protection; there are “significant, unexplained” price increases; there is no direct competition; and the drug is no longer made or sold in the US by the original manufacturer.
“If you were to take this action, several drugs cited in the media for rapid price increases could be addressed immediately,” the senators wrote to Burwell. Since the drugs are still sold by a generic company or made by the original manufacturer, which had received FDA approval to sell its drug in the US in the past, “there is no reason not to grant expedited approval.”
We asked HHS for comment and will update you accordingly. [UPDATE: An HHS spokesman writes us that the agency will respond directly to the senators, but otherwise did not comment.]
Importation, of course, has been kicked around for years. And various lawmakers regularly introduce legislation to allow the practice. Meanwhile, over the last few years, the FDA and law enforcement authorities have taken various actions against many Internet pharmacies, including filing civil and criminal charges, seizing products and closing down websites.
Earlier this year, a federal judge invalidated a Maine law that allowed residents to buy prescription drugs through a broker from pharmacies that were licensed in Canada, the UK, New Zealand, and Australia. The judge ruled that federal law trumped state law, which was another way of saying that the FDA had jurisdiction over importation.