On July 31st, the Trump Administration formally announced a preliminary proposal to allow the importation of prescription drugs in an effort to bring down rising prices. However, it appears that one of the proposal’s provisions may exclude insulin from the list of drugs that would be considered for importation.
In a press release, the Department of Health and Human Services (HHS) outlined the two proposed pathways for importation.
-With the first pathway to drug importation, the federal government could greenlight pilot projects proposed by states, wholesalers, and pharmacies for importing versions of FDA-approved drugs from Canada. Currently, Florida, Vermont, and Colorado have approved measures to import less expensive drugs from outside the United States.
However, this pathway, if implemented, may exclude insulin from the list of drugs allowed to be imported. The proposal released today contains an exclusion list that bars certain types for drugs – such as biologics – from importation. Earlier this year the FDA unveiled a rule change to reclassify insulin as a biologic by March 2020.
There is a second pathway, however, in today’s proposal that may provide an option for the importation of less expensive insulin from abroad. Under this pathway, the FDA would create a new drug code that would allow drug manufacturers to import versions of FDA-approved drugs that they currently are selling in foreign markets at a lower price.
HHS Secretary Alex Azar said the proposed rule was designed to allow American consumers a better opportunity to buy drugs at a price similar to what consumers pay in other countries.
“Today’s announcement outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the Administration’s work to end foreign freeloading and put American patients first,” he said.
A reversal of policy by the federal government
This represents a reversal by Secretary Azar, who stated in 2018 that drug importation is “a gimmick”, one that the Congressional Budget Office found would have “no meaningful effect” on the prices U.S. consumers pay for drugs.
The high price of prescription drugs has become a hot-button issue leading up to the 2020 elections. In the July 30th debate between half the candidates seeking the Democratic nomination for president, two candidates, Senators Amy Klobuchar (D-MN) and Bernie Sanders (D-VT), decried the high prices un- and under-insured people with diabetes pay for insulin, for example.
While President Trump has spoken often about the need to lower the price of prescription drugs, the cost of these drugs has continued to rise during his term in office. This month, an analysis by Rx Savings Solutions, a company which works with consumers to save on prescription drugs, found that the cost of prescription drugs rose at five times the rate of inflation in the first half of 2019. The president has proposed a number of ambitious measures to combat rising drug costs, but has yet to successfully implement the measures.
On July 21st, we asked T1D Exchange Glu members where relief might come from the high price of insulin. You can see the results from that poll below:
Photo credit: Official White House Photo by Joyce N. Boghosian – President Trump Signs an EO on Healthcare Transparency on June 24th. HHS Secretary Alex Azar, right foreground.