New Law Relaxes Drug Importation
November 8, 2000
While prescription drug policy was featured prominently in the presidential race, the only action this year will be a bill from Congress that lifts restrictions on the importation of drugs approved by the Food and Drug Administration (FDA). The move represents a change in congressional policy.
- The bill permits not only reimportation of American-made drugs, but also the importation of FDA-sanctioned drugs manufactured elsewhere.
- Congress restricted the importation of prescription drugs in the late 1980s in response to safety and quality concerns.
- The 1987 Prescription Drug Marketing Act made it illegal for anyone other than the manufacturer to import a drug into the United States.
- The bill, now awaiting President Clinton's signature, will add pharmacists and wholesalers to the list of those who can import drugs.
The FDA would develop specific rules to oversee drug importation. The legislation would allow imports only from Australia, Canada, Israel, Japan, New Zealand, South Africa, Switzerland and countries in the European Union and European economic area. Other restrictions also would apply, for example:
- Importers would have to use FDA-approved labels, and if manufacturers refuse to provide the labels the imported drugs can't be sold.
- The regulation governing the importation of drugs couldn't take effect until the Dept. of Health and Human Services demonstrated the imports would result in significant cost reduction and wouldn't pose additional safety risks.
Critics complain the bill doesn't get to the real issue, lack of insurance coverage.
Source: Jane Cys, "Price Relief Coming? Congress Passes Drug Importation Bill," American Medical News, November 6, 2000.
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