COMPARING THE BILLS
Two U.S. Senate bills would allow drug importation into the United States from Canada and other countries. How they compare: Pharmaceutical Market Access and Drug Safety Act (Democrat-sponsored) [S.2328] 1. The FDA has 90 days to create rules permitting drug importation. U.S. pharmacies and drug wholesalers can import medicines from Canada in the first year and 19 other countries thereafter. Individuals could be shipped prescriptions from mail order or Web sites from FDA-approved Canadian pharmacies. 2. It's unlawful for drugmakers to limit supply or alter drugs to fail FDA standards. 3. A 1 percent user fee is imposed to fund FDA inspections. 4. Exporters to individuals must post a bond that they forfeit if they send unsafe drugs.
Safe Importing of Medical Products and RX Therapies Act (GOP-sponsored) [S.2493] 1. The FDA has one year to make safety recommendations before permitting imports from Canada and up to three years for 15 European Union countries. The FDA could ban drugs from some nations. 2. There is no provision making it unlawful to reduce supply or alter drugs to fail FDA standards. 3. A new, uncapped user fee program is established, paid for by all foreign and domestic businesses engaged in importation to pay for FDA inspections. 4. Licensing requirements and penalties are established for all online pharmacies that illegally conduct or solicit U.S. business.
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Saturday, July 17, 2004
Reimportation bill stalls in Senate.
Ruby L. Bailey wrote a good piece on reimportation in yesterday's Detroit Free Press (provided here courtest of the San Jose Mercury News). In particular, she provided a concise comparison of the competing Senate bills:
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