May 12, 2017
While voting to advance a bill on the FDA’s funding, the Senate Health, Education, Labor and Pensions (HELP) Committee voted down a measure within the legislation that would have allowed the importation of cheaper generic drugs from Canada.
The majority Republican committee voted down the measure after citing safety concerns associated with the sale of foreign drugs in the United States. They also argued that the measure would not provide significant reductions in overall drug spending.
“While I understand the intent is to lower the cost of prescription drugs, we would be subjecting Americans that benefit from the safest drug supply distribution chains in the world to a severe public health risk for what the Congressional Budget Office has told us will not lower the cost of prescription drugs” Senator Orrin Hatch (R-Utah) said during debate on the amendment.
The Amendment’s sponsor, Senator Bernie Sanders (I-Vermont) countered that the safety concerns cited by Republicans are adequately addressed within the amendment. Senator Sanders and other Democratic members on the panel pointed to the safety concerns as a strategy to uphold the status quo of protecting pharmaceutical companies from legislation that could hurt their business.
“This legislation includes very clear language that any product coming into this country has to come from an FDA-approved facility,” Sen Sanders said during the committee hearing. “Bottom line here is… we’ve gone on year after year and neither a Republican administration or a Democratic administration had the guts to stand up for lower drug prices in this country.”
According to the amendment foreign sellers must register with the FDA, must meet specific safety criteria, and must be FDA inspected. Furthermore, the amendment requires patients to provide a valid prescription before importing drugs from Canada and gives the FDA authority to shut down sites that aren’t compliant with safety protocol.
However Sen Hatch pointed out that a significant amount of drugs supplied to Canada are imported from foreign facilities, and that Canada does not rigorously inspect the majority of these facilities. He argued that this would leave Americans open to safety issues from drugs manufactured outside of Canada, but imported through this measure.
Senator Tim Kaine (D-Virginia) argued that while the safety concerns are legitimate, denying Americans access to drug importation is out of touch with reality.
“I think the safety issues are not made up—I think they are serious,” Senator Kaine said. “But I’m supporting [the measure] because so many Americans are doing this. Members of my family—and they’ve done it for years. And the notion that we can’t do this is just completely contradicted by the actual reality that people are living right now.”
The Senate HELP Committee ultimately passed the FDA Reauthorization Act after voting 13-10 to reject the Canada drug importation amendment.
“Today our committee took an important step in the timely reauthorization of the user fee agreements that fund the FDA, the agency that is responsible for making sure the promising research supported by the 21st Century Cures Act actually reaches patients,” Committee Chairman Senator Lamar Alexander (R-Tennessee). “I am encouraged by today’s progress and look forward to renewing these agreements on time to bring certainty to the agency, and most importantly, to the patients and families that rely on medical innovation.”
The final bill did include amendments to give the FDA authorization to speed up the approval process for generic drugs in order to cut down on price gouging practices and to allow the sale of hearing aids over the counter. Senator Alexander also confirmed that the committee will soon hold a hearing to address the current drug pricing situation in the United States.