As readers of this blog know, we have been following the proposed Pharmaceutical Market Access and Drug Safety Act carefully as it wends its way through Congress. So far, neither the House nor Senate versions of the bill have gotten very far since their introduction in early March, although there has been some talk that the Senate bill may be put to a vote within a matter of weeks.
For those of you who would like to learn more about this proposed legislation, which would allow American consumers to legally purchase prescription drugs from Canada and other Tier One countries, you can read the full text of the House bill here, and a summary here.
Why do we need this legislation passed? The bill makes the case in seven points:
And what would passage of the bill achieve? Here’s a summary:
Pharmaceutical Market Access and Drug Safety Act of 2009 – 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: (1) a registered importer; or (2) an individual for personal use.
Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services 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.
We wholeheartedly support the Pharmaceutical Market Access and Drug Safety Act, and we encourage you to contact your Congressman and Senator to show your support as well.98