Now that Tom Price has been confirmed to head the US Department of Health and Human Services, a trio of lawmakers is after him to allow Americans to import medicines from Canada. And their names are familiar to anyone who has tracked this particular notion, which has regularly been proposed — and just as often ignored or swatted down — as a fix for the vexing problem of prescription drug costs.
In a letter sent to Price on Tuesday, the lawmakers — Senator Chuck Grassley (R-Iowa), Senator Amy Klobuchar (D-Mn.) and Senator John McCain (R-Az.) — urged the newly anointed cabinet member to use his statutory authority to fast-track importation from Canada under certain circumstances. And those circumstances include situations in which competition is lacking or there are sudden and huge price hikes.
This is only the latest attempt by these same lawmakers to find a way for Americans to import medicines from Canada. Over the past couple of years, they have each introduced legislation or written letters to HHS urging importation. But given that President Trump has informally voiced support for the idea — and twice attacked drug makers over high prices — they apparently see an opening to renew their call.
Moreover, their letter was sent after yet another controversy over a high-priced medicine erupted. Last week, Marathon Pharmaceuticals won approval to sell a decades-old medicine for a rare form of muscular dystrophy and set an $89,000 annual price tag, before rebates and discounts. But the same drug is available for about $1,000 from online pharmacies supplied by pharmacies in the UK and Canada.
Compounding matters, there is no competition. The drug was awarded an orphan designation, which is granted to medicines for treating a rare disease with a patient population of fewer than 200,000 people. This means that Marathon has seven years of exclusive marketing rights before a rival medicine can be approved for the US. The circumstances prompted outrage from a pair of other lawmakers and parents.
A somewhat similar example involved Daraprim. In 2015, Turing Pharmaceuticals, which was run by Martin Shkreli, bought a decades-old, life-saving anti-infective and raised the price by 5,000 percent, to $750 a pill. And Turing prevented generic competition through a closed distribution system. At the time, a version sold by GlaxoSmithKline was available online from overseas pharmacies for $1.72 a pill.
Under a 2003 law, the US Food and Drug Administration can issue waivers for individuals to import pharmaceuticals for personal use. But importation is not otherwise permitted until the HHS secretary certifies that importation would not pose a health risk and could lower consumer costs. And ensuring safety of imported medicines has been cited by both drug makers and regulators as a concern.
The lawmakers acknowledge it would be difficult for HHS to certify that importation of all drugs from Canada are safe, but as they have argued previously, the senators believe the department could do so in a “targeted manner” and still meet safety standards, according to their letter. And they maintain a policy could be followed that does not dissuade companies from investing in new medicines.
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. These are, by the way, the same criteria that Grassley and McCain mentioned in a letter to HHS in November 2015.
To what extent this effort gains any traction is unclear. As we noted, importation is regularly suggested as one way to mitigate the rising prices many Americans pay for their medicines, but the pharmaceutical industry has successfully persuaded Congress not to embrace the concept. And while Trump may favor methods to lower costs, the Republican-controlled Congress may continue to resist this particular idea.