By Jacquie Lee
The FDA is considering importing drugs from Europe if prices on medicines made by a single U.S. manufacturer spike, the head of the agency said.
“These disruptions can create public health consequences that are similar to the occurrence of a drug shortage,” Scott Gottlieb, commissioner of the Food and Drug Administration, said in a July 19 statement.
The move would be a major shift in American drug policy. It’s generally illegal for private citizens to import foreign drugs if a similar product is already available in the U.S., even if they can’t afford the domestic version. Cost has become one of the biggest obstacles for patients to access medicine and has sparked a national conversation on drug prices.
Gottlieb’s comments come two days after he announced the FDA’s plan to allow drug companies creating cheaper versions of biologic drugs to use European drugs as a reference. Those cheaper biologics, called biosimilars, must use samples of an already existing biologic to prove their copy’s effectiveness. Biologic drugs are expensive to make because they are complex and made from living cells.
The types of drugs the FDA would consider importing fall under a narrow definition. The agency is only considering importing single-sourced drugs with “no blocking patents or exclusivities associated” with them, which could include both branded or generic drugs. Roughly 90 percent of prescriptions filed in the U.S. are for generic drugs, but brand drugs are primarily driving drug costs, according to the FDA. They cost up to roughly 85 percent more than their generic counterparts.
“We want to examine whether—under these narrow conditions—the additional market 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 U.S. until new competition is able to enter the domestic market,” Gottlieb said.
The agency still needs to consider what regulatory pathways it should follow in order to import drugs while ensuring they’re safe. It also must decide the price ceiling a single-source drug can hit before it’s considered a barrier for patient access.
Rough Road Ahead
The agency has authority to address drug shortages, including importing drugs, David Horowitz, a partner at Hogan Lovells US LLP based in Washington, told Bloomberg Law. Horowitz specializes in FDA and HHS regulatory law. He suspects the agency will have a rough road ahead when Gottlieb tries to follow through on his plan.
The agency is constrained by a 2013 court case that “limits FDA’s ability to allow importation of unapproved versions of approved drugs, without regard to the degree of competition that exists for the FDA-approved product,” Horowitz said.
The head of the Department of Health and Human Services must also ensure that importing drugs poses no additional risk to public health and safety and that the new drugs would “result in a significant reduction in the cost of covered products to the American consumer,” Horowitz said. No HHS secretary has been able to certify that standard, Horowitz said. That means the FDA’s work group for this issue “will have a very challenging task unless FDA receives new legislative authority,” he said.
Plan Gets Mixed Reviews
Some are skeptical of importation in general being treated as a cure-all for high prices in the U.S. Len Nichols, an economist and director of the center for health policy research and ethics for George Mason University, is one of the skeptics.
“It sounds great,” he said, but it would give drug companies an incentive to stop selling drugs to the countries from which the U.S. is importing them.
“If that became a serious avenue from which drugs were acquired it would take about an hour before they stop selling in France and just sell here,” Nichols told Bloomberg Law July 19.
Reactions from a variety of health-care related groups have been mixed. The Association for Accessible Medicines, a group that represents generic drugmakers, is grateful the agency is taking drug pricing seriously, but said importation doesn’t solve the problems with the U.S. drug price system.
Sen. Lamar Alexander (R-Tenn.) said in a statement he supports the plan “so long as the Food and Drug Administration approves the safety and effectiveness of those drugs and of the supply chains that carry them to American consumers.”
The leading industry group for branded pharmaceutical companies said importation “is not the solution.” Importation plans “circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system,” the Pharmaceutical Research and Manufacturers of America said.