US Health and Human Services Secretary Alex Azar on Thursday directed the FDA to explore how to safely import prescription drug products from other countries “in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.” Such imports “could help address price hikes and supply disruptions that are harming American patients,” Azar stated.
Citing the highly publicized case of Turing Pharmaceuticals’ toxoplasmosis drug Daraprim (pyrimethamine), whose list price was increased by more than 5000 percent in 2015, Azar noted that there have been “a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities,” and that “safe, select avenues for importation could be one of the answers to these challenges.” He added that when US President Donald Trump recently released a blueprint aimed at cutting US drug costs, “I said we are open to all potential solutions, assuming they are effective, safe for patients, and respect choice, innovation and access.”
FDA Commissioner Scott Gottlieb said the agency will be forming a work group to develop drug importation policy options to address the issue. He emphasized that the group will focus on certain critical medicines where there is only a single manufacturer, but no blocking patents or exclusivities. “Under these narrow conditions,” Gottlieb said the work group will examine whether the added competition “from the short-term importation of foreign versions of the drug may complement the FDA’s current efforts, and help meet near-term patient need in the US.”
Gottlieb noted that any importation of foreign-approved drugs would be a temporary measure “until adequate competition enters these categories” in the domestic market. Further, he added that any policy would also be tailored to avoid the risk of counterfeits or other unsafe products entering the US supply chain.
The importation move is the latest in a series of initiatives unveiled by the US administration in a bid to curb drug costs in the country. In January, Gottlieb announced steps to further encourage competition in the generic drug sector as part of the FDA’s continued implementation of the Drug Competition Action Plan, while earlier this week the agency released another plan designed to facilitate the development, approval and market entry of biosimilars.
Meanwhile, Trump has also taken to Twitter to criticize pharmaceutical companies for raising drug prices, which resulted in Pfizer recently backpedaling on price increases for certain drugs that came into effect on July 1. Earlier this week, Novartis also decided against raising prices on its prescription products in the US for the rest of the year.