The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.
Martin Shkreli and the 5,000 percent Daraprim price hike continue to cast a shadow over the pharmaceutical supply chain. Shkreli’s company had a monopoly on the drug and for patients, it was pay the price hike or don’t receive the toxoplasmosis treatment.
Now, with Shkreli in federal prison (on unrelated charges, the massive price hike was totally legal), the U.S. Food and Drug Administration is looking to address such supply chain threats by potentially importing foreign drugs under a narrow scope. On Thursday, FDA Commissioner Scott Gottlieb said there are times when “conditions may develop” that block patient access to drugs. Without mentioning Shkreli by name, Gottlieb pointed to single-source drug providers who can initiate “significant price increases that close off channels of availability.” Those price increases, which can happen on an older drug without generic equivalents, such as Daraprim, can create public health consequences that are similar to the occurrence of a drug shortage, Gottlieb said in a statement. As a result, the FDA is now exploring the idea of importing foreign drugs “help meet near-term patient need in the U.S. until new competition is able to enter the domestic market.” The FDA working group will explore how such importation could work, particularly given questions of safety and efficacy. Those concerns are why any such policy if implemented, would be narrow, Gottlieb said.
“… any resulting policy would also be narrowly tailored in order not to create the same risks of counterfeits or other unsafe drugs getting into the U.S. supply chain as a broader importation policy would present,” Gottlieb said in a statement.
Importing foreign drugs was something that President Donald Trump touted during his campaign as a potential remedy to lowering prescription prices in the United States. While the president, and indeed many consumers who look to foreign drug sources for their treatments, support the idea, the pharmaceutical industry does not. Following the FDA’s announcement, the Pharmaceutical Research and Manufacturers of America (PhRMA) confirmed its opposition to the idea. The industry lobbying group said importing drugs, even under the limited scope that the FDA outlined in its proposal, is not the right answer to a Shkreli-like problem.
“Drug importation schemes circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system,” PhRMA said in a statement, according to The Hill.
The industry organization added that the FDA should focus on efforts to increase patient access to generic drugs, The Hill reported.
Gottlieb stressed that any importation if that is what happens, would be temporary. The hope, Gottlieb said, would be for other drug manufacturers to step up and produce their own version of the medication in question, such as a Daraprim, to ensure adequate supplies, as well as increased competition.
“Our ultimate goal is to seek multiple FDA-approved and marketed versions of each medically important drug for which there are no blocking patents or other exclusivities. The agency has advanced a number of new initiatives, as part of our Drug Competition Action Plan, to pursue this primary and overriding objective of stable, safe and effective competition,” Gottlieb said.
