Researchers Make Case for Some Off-Patent Drug Imports
Researchers from Harvard, Yale, and Johns Hopkins universities say that facilitating patient access to drug manufacturers that had obtained approval from any of seven non-U.S. regulators (the European Union, Canada, Australia, New Zealand, Switzerland, South Africa, and Israel) could help sustain affordable access to essential off-patent drugs. Writing in The BMJ, the researchers say they wanted to determine whether off-patent prescription drugs at risk of sudden price increases or shortages in the U.S. are available from independent manufacturers approved in other well regulated settings around the world.
They looked at off-patent drugs in the U.S. and approved by FDA up to 4/10/17.
“International sources could improve the supply and increase the competition for off-patent drugs in the U.S. with insufficient competition, about two-thirds of which had at least one additional manufacturer with a version approved by a non-U.S. regulator,” the report says. “Including the seven non-U.S. peer regulators, nearly 40% of the drugs in our analysis could be served by four or more manufacturers, helping ensure low prices and avoid unexpected shortages. Most of these drugs treat infectious diseases, neurological and psychiatric diseases, or cardiovascular diseases, diabetes, or hyperlipidemia, some of the most prevalent and preventable medical conditions affecting U.S. patients.”
The authors say that any reciprocal style approval system should include generic drugs already approved and used in the U.S. with well-established safety and efficacy profiles, as opposed to brand name drugs without previous FDA approval. They also say that importations should occur only from manufacturers approved by non-U.S. peer regulators with strong safety records under a baseline set of requirements for approval. And they say that FDA’s role in drug approval should be central, for instance by the agency reserving the right to require different labeling and the right to deny reciprocal approval of qualifying drugs, along with an opinion explaining its rationale.
“Our findings suggest that a formalized system of importation of off-patent prescription drugs with insufficient U.S. generic competition would not on its own fully solve the issue of their rising prices and shortages,” the researchers conclude. “One way in which such a system may increase competition is by providing incentives for international suppliers to enter U.S. drug markets by lowering the cost of FDA approval. Reciprocal approval could also facilitate regulatory responses to mitigate bad public health outcomes when drugs face shortages or dramatic increases. Thus, international sources could lead to increased U.S. competition for a meaningful number of drugs and might be worth pursuing in concert with other strategies.”