The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.
HHS announced today the publication of its Safe Importation Action Plan, a document outlining 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.
HHS Secretary Alex Azar said in a statement that the plan is intended to address the problem of American patients “paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices.” According to Azar, the plan “is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”
The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking (NPRM) to authorize importation of drugs from Canada. States, wholesalers, and pharmacists would be allowed to submit plans outlining how they would import approved Canadian drugs for demonstration projects for HHS to review.
“The importation would occur in a manner that adequately assures the drug is what it purports to be and that meets the cost requirements of the rulemaking,” the plan states, and the demonstrations would be time-limited.
Certain conditions—regarding drug quality, record keeping, testing, and protections against counterfeiting—would have to be met, and the NPRM would list requirements and invite proposals on how those conditions would be met.
Eligible drugs would include those that are Canadian-authorized versions of FDA-approved drugs. These drugs would have to contain active pharmaceutical ingredients manufactured at facilities that also manufacture API for the FDA-approved version, and biologics (including insulins), infused drugs, and certain other drugs would be excluded from importation under this pathway.
The second pathway would allow manufacturers to import versions of FDA-approved drugs—potentially including insulins and drugs that treat rheumatoid arthritis and cancer, though HHS did not specify which products these potential inclusions might encompass—that are sold in other countries. The manufacturer would need to establish that these drugs are the same as those sold in the US by providing manufacturing records.
“The Administration has reason to believe that manufacturers might use this pathway as an opportunity to offer Americans lower cost versions of their own drugs,” the plan indicates. HHS says that it may see comments on whether manufacturers would seek to lower costs to patients under this second pathway. If costs can indeed be lowered through this approach, there may be a reduced need for the demonstration projects described in the first approach, the plan indicates.
Acting FDA Commissioner Ned Sharpless, MD, said in a statement, “We support the President and Secretary’s efforts to bring down drug prices for Americans. The FDA has a unique role to play in promoting competition that in turn can help reduce drug prices and improve access to medicine for Americans.” Sharpless added that “We’ve been keenly focused on ensuring the importation approaches we’ve outlined pose no additional risk to the public’s health and safety. We know there are many operational challenges to address through each of these pathways, and are actively working through them as we look to formally announce these policies, with opportunity for public comment, in the coming months.”