As part of a plan to lower the cost of prescription drugs, President Donald Trump, along with the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA), have issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance that describes procedures that drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are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.

The NPRM is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to public health and safety while achieving a reduction in the cost of covered products. The draft guidance describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in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.

The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Referred to as Section 804 Importation Programs, these programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required US labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards as well as represent a cost reduction.

Of note, the draft guidance describes procedures drug manufacturers could follow to obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products, that were originally manufactured, and intended to be marketed, in a foreign country. The HHS says that the use of an additional NDC would allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require.

The draft guidance also recommends that the drug manufacturer include a statement on the product’s label and in the prescribing information to assist pharmacists to accurately identify, dispense and bill for these products. Prescription drugs, including biological products, imported under the pathway described in the draft guidance could be available to patients in a variety of settings, including hospitals, healthcare providers’ offices, or licensed US pharmacies, and would include the FDA-approved labeling (including prescribing information).

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

Industry groups oppose the proposal

The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued a statement opposing the drug-importation plan.  

“At a time when there are pragmatic policy solutions being considered to lower costs for seniors at the pharmacy counter and increase competition in the market, it is disappointing the Administration once again put politics over patients,” he said in a December 18, 2019 statement. “The Administration chose to proceed with an importation scheme that could endanger American lives, could worsen the opioid crisis and has been called unworkable by Canadian officials. Instead, they could have worked with stakeholders to develop and advance meaningful solutions that would directly benefit patients. We are reviewing the details of the proposed rule and draft guidance and will be providing the Administration with our comments and concerns with the hope that no patients are endangered by this political maneuver.”

Source: US Department of Health and Human Services