FDA Guidance Aims at Lowering Drug Costs


The new rule outlines procedures for the importation of drugs that were manufactured outside of the United States.

The US Department of Health and Human Services and the FDA are continuing their quest to bring safe, effective, and affordable drugs to the American public through the Safe Importation Action Plan. This week, they issued a final rule of the July Executive order regarding importing certain prescriptions from Canada.

The rule implements a provision of federal law, allowing certain programs that are authorized by the FDA to import certain drugs from Canada. The goal is to have the prescriptions available at a lower price, while ensuring that they do not pose any additional risk to health and safety.

“Today’s action is an important part of FDA’s priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” said FDA commissioner Stephen M. Hahn, MD, in a statement on Thursday.

The final guidance outlines procedures that drug manufacturers need to follow that will lead to the allowance of importing FDA-approved prescription drugs and biological products that were manufactured abroad. Now, states (including Washington, DC, territories, and Indian tribes) can submit importation program proposals for the FDA to review and authorize. In the future, pharmacists and wholesalers will be able to submit proposals as well.

Once a drug is deemed eligible, it will be relabeled with US labeling and will be tested for authenticity or degradation and standards.

Now that drugs manufactured abroad can obtain a National Drug Code (NDC), companies can offer them at a lower price than they would be able to otherwise, as current distribution contracts require.

“The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines,” Hahn said.

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