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Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.
Those circumstances are: If a drug is off patent or no longer marketed in the US by the innovator company that initially developed that drug; if there are “significant and unexplained increases in price”; if no direct competitor drug is currently marketed and the introduction of such a competitor will lower prices for taxpayers and consumers; or if the drug is produced in another country by a brand name manufacturer or by a “well-known generic manufacturer that commonly sells pharmaceutical products in the US.”
The senators call for this action as under the statute Price has the authority to issue the certifications in a targeted way to address the current circumstances and in a way that “does not negatively affect innovator companies that invested in the development of the drug.”
The letter comes as the US Food and Drug Administration (FDA) last week approved a Duchenne Muscular Dystrophy treatment that its sponsor said would cost more than 50 times the price of what patients currently pay for the steroid overseas and in Canada.
Sens. Bernie Sanders (D-VT) and Rep. Elijah Cummings (D-MD) took issue with that price yesterday and Marathon Pharmaceuticals, the company that won approval for Emflaza (deflazacort), said yesterday that it paused its launch of the drug in the US. The company did not respond to a request for comment.
But wider efforts to allow for reciprocal drug approvals from Canada and the EU may not actually lead to increased benefits for US patients, according to a study published last week in the BMJ.
The study found that: “If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms.”
That conclusion was reached after finding that 12 of the 37 drugs with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons—including two drugs that were ultimately withdrawn from the market in Europe due to safety concerns.
Industry trade group PhRMA has also taken issue with the prospect of allowing drug imports to the US in some cases, noting the prevalence of counterfeit drugs elsewhere.
Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices