Allowing the importation or reciprocal approvals of generic drugs for those with limited competition in the US could help the country better manage price spikes and shortages, researchers from Johns Hopkins, the Council on Foreign Relations, Yale University and Harvard Medical School, said in a new observational study published in the BMJ
So how would such a variation on reciprocal approvals work? The researchers say the US Food and Drug Administration (FDA) could approve drugs based on evidence from a previous approval by another stringent national regulatory authority.
“FDA could limit the use of this reciprocal drug approval process to countries with stringent national regulatory authorities and strong safety records, and which the FDA has assessed as having equivalent generic drug approval processes,” the study said. “The few areas in which there remain significant differences among comparable regulators, such as approval of generic narrow therapeutic index drugs, could be excluded from the reciprocal process. The reciprocal approval could also be made contingent on the manufacturers starting the process for standard FDA approval.”
Previous plans for such reciprocal approvals, even with the European Medicines Agency or Health Canada, have raised questions about a “race to the bottom” – meaning companies could figure out which regulator is the easiest in terms of approval standards and all generic drug applications would be submitted to that one regulator.
Thomas Bollyky, senior fellow for global health, economics, and development at the Council on Foreign Relations, explained to Focus
: “The risk of a ‘regulatory race to the bottom’ can be managed with several measures. First, reciprocal approvals should be limited to those manufacturers approved by non-US peer regulators with strong safety records, as determined through a prior assessment by FDA of the equivalence of those generic drug approval processes. Second, the reciprocal approval pathway should be designed in a manner that preserves the FDA’s role in generic drug approval.”
The call for such a shift follows the researchers’ finding that importation of such generic drugs would help “slightly less than half reach a threshold number of generic competitors sufficient to address periods of drug shortages and substantial price increases,” and that such reciprocal approvals could help with rising prices and shortages of off-patent drugs. Such a deal would also build on an agreement forged by FDA and their European counterparts
to mutually recognize drug manufacturing inspections.
And there are some within FDA who have previously taken the position that reciprocal approvals would work in some circumstances.
Paul Howard, former director of health policy at the Manhattan Institute, who’s currently a senior adviser to FDA Commissioner Scott Gottlieb, in 2014 wrote an article entitled: “If a Drug is Good Enough for Europeans, It’s Good Enough for Us
Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) have also sought ways to fast-track the importation
of off-patent drugs from Canada, though previous FDA commissioners have pushed back on the safety implications of such a move.
The researchers also point to several specific examples of when a reciprocal approval system would work. For instance, for albendazole, a broad spectrum antiparasitic drug, there are no generic versions approved by FDA, but three generics approved by non-US drug regulators.
They also noted nitisinone, which treats hereditary tyrosinemia type 1, and nabilone, which treats chemotherapy-induced nausea and vomiting, were the only drugs with no generics approved by FDA and four or more generics approved by non-US regulators.
“It is likely to be faster and more efficient for current manufacturers of an already approved drug to expand production to serve the US market than for a manufacturer to newly enter the market by obtaining FDA approval and building new manufacturing capabilities,” they wrote. “Such a system would also allow patients in the USA to access drugs manufactured by previously non-FDA approved companies that may have otherwise been deterred by the cost of an additional approval from the FDA. Thus, the possibility of international competition for US generic drugs would reduce the risk and duration of shortages, and diminish the ability of manufacturers to impose large price increases of generic drugs with limited US competition.”