Drugs

Don’t Authorize Florida Drug Import Program: Petition

A 1/7 petition submitted on behalf of Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage asks FDA not to authorize the state of Florida’s drug importation program proposal and to disclose the identities of foreign sellers for public comment.

Florida submitted its proposal following a 9/24/20 HHS certification that implementation of the commercial importation provisions of Section 804 of the Federal Food, Drug, and Cosmetic Act will not pose any additional risk to the public health and safety and will result in a significant reduction in the cost of covered drugs to the American consumer. The petition says that also on 9/24/20 HHS and FDA issued a final rule permitting the commercial importation of certain prescription drugs from Canada without the manufacturer’s authorization.

The three organizations that submitted this petition filed suit challenging the certification and final rule on 11/23/20. The same day the suit was filed, Florida submitted its drug importing proposal to FDA for review.

“FDA is not authorized to approve the proposal because the certification is invalid and the final rule is unlawful for the reasons described in the litigation,” the petition says. “As for the petition itself, it does not include the name of the Canadian wholesaler, which the final rule refers to as the ‘foreign seller,’ and FDA cannot approve a Section 804 Importation Program unless and until a foreign seller is identified who meets all the requirements of the statute and the final rule.”

The petition also argues that the agency should not authorize the proposal because it would jeopardize patient safety and lists other reasons why the groups believe the proposal should not be authorized.

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