Trump administration takes first step in implementing provisional law to control drug prices
As per the law, manufacturers can import the drugs from Canada, which are intended to sale in another country
A notice of proposed rulemaking (NPRM) has been issued today by President Trump along with U.S. Department of Health and Human Services and the U.S. Food and Drug Administration. This allows the importation of the prescription drugs from Canada. Administration announced new draft guidance which describes the procedures for drug manufacturers to follow to import the drugs including biologics approved by the US FDA.
This is the first step in implementing provisional law that allows the importation of the prescriptions drugs without posing any risk to safety and efficacy. The guidance also includes the documentation to be submitted by the manufacturer for importing the drugs that are FDA approved.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex Azar.
The NPRM would allow state entities and non-federal entities to submit proposals to import the drugs to FDA. This can co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity, FDA monitors the importation of the products. This is expected to reduce the cost of prescription drugs in the United States.
The guidance describes the procedures that should be followed by the manufacturers to get the National Drug Code (NDC) for drugs including biologics which were originally manufactured in foreign country and are intended for sale in foreign country.
The comments are accepted for 75 days after publication in the Federal Register.