It's back, old reimportion bill gets new life!posted Wed, 9 Mar 2011
Like a spring perennial, the “Pharmaceutical Market Access and Drug Safety Act” has been reintroduced in Congress. You might recall this legislation from the 2005, 2007 and 2009 sessions. It was formerly known as the Dorgan/Snowe bill, but now it’s the Stabenow/Snowe bill (S.319).
This iteration has been mercifully reduced from 35 plus pages to 11 pages, and it has shed some of its more restrictive sections.
From a consumer’s perspective, it specifically allows personal importation. It tends to focus on importation by U.S. licensed pharmacies and drug wholesalers. It establishes new layers of oversight, inspections, reporting and bonding requirements—upon both exporters and commercial importers. Consumers have to wonder how much these changes will drive up costs.
Specifically, the Act:
“Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States.
Prohibits the importation of a qualifying drug unless such drug is imported by a registered importer or an individual for personal use.
Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions.
Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.
Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug.
States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.
Requires the Secretary to educate consumers regarding prescription drug importation.
Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA.
Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.”
Sen Snowe, Olympia J. [ME] (introduced 2/10/2011)
Sen Stabenow, Debbie [MI]
Sen Begich, Mark [AK]
Sen Bingaman, Jeff [NM]
Sen Brown, Sherrod [OH]
Sen Collins, Susan M. [ME]
Sen Grassley, Chuck [IA]
Sen Johnson, Tim [SD] Sen Kerry, John F. [MA]
Sen Klobuchar, Amy [MN]
Sen Kohl, Herb [WI]
Sen Leahy, Patrick J. [VT]
Sen Levin, Carl [MI]
Sen McCain, John [AZ]
Sen McCaskill, Claire [MO]
Sen Nelson, Bill [FL]
Sen Sanders, Bernard [VT]
Sen Shaheen, Jeanne [NH]
Sen Vitter, David [LA]
Retrieve the full text of the Stabenow/Snowe bill
Retrieve the full text of the 2009 Dorgan/Snowe bill