President Donald Trump, along with the Department of Health and Human Services and Food and Drug Administration, released a notice of proposed rulemaking and draft guidance on Dec. 18 that when finalized would allow the importation of certain drugs to ensure price regulation.
The notice of proposed rulemaking (NPRM) and the draft guidance are now open to public comments after being published on the Federal Register.
“The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application,” said the Department of Health and Human Services (HHS) in a statement.
In a series of steps to make drugs more affordable that the Trump administration called “historic,” the HHS said that the importation will not allow any risk to public health and safety.
“In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country,” said the HHS.
HHS Secretary Alexa Azar praised Trump for the plan, which follows two potential pathways for importation.
The administration had earlier published a Safe Importation Plan (pdf) that describes these two potential pathways.
One would allow drugs to be imported from Canada, and the other would allow drug makers to import their own drugs using “a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.”
Azar had earlier told Trump during a cabinet meeting on Oct. 21 that his department is working on the scheme to import drugs from Canada and is trying to get the “same kind of deals for the American senior that other developed countries are getting.”
Trump remarked last year that he has made reducing prescription drug prices a priority and is making efforts to find solutions.
While Trump administration has come up with its safe importation plans, certain quarters have expressed concerns if it can really solve the problem.
“We hope the Administration will work with Congress to pass a comprehensive drug pricing reform package and finalize its international pricing index model, actions that would begin to address the fact that Americans pay two to three times more than citizens in other nations for the same drugs,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now in a statement in response to the Wednesday’s announcement.
Alan Sager, Director of Health Reform Program at the Boston University School of Public Health, told The Epoch Times that importing drugs from Canada may help to lower prices to some extent.
“That’s partly because only some drugs would apparently be involved. If importing does lower prices, success would rest on Canadian government price regulations.
“In effect, U.S. manufacturers’ brand name drugs are exported to Canada, are then subjected to Canadian price regulation, and finally would be reimported to the U.S. We would wash our drugs in Canadian laundromats to get them clean—to lower their prices,” said Sager.