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Angie Drakulich was editorial director of Pharmaceutical Technology.
Senators Byron Dorgan (D-ND), Olympia Snow (R-ME), John McCain (R-AZ), and Debbit Stabenow (D-MI) introduced a bill March 4 that would allow pharmacists and wholesalers to import prescription drugs from Australia, New Zealand, Japan, Switzerland and the European Union.
Senators Byron Dorgan (D-ND), Olympia Snow (R-ME), John McCain (R-AZ), and Debbie Stabenow (D-MI) introduced a bill on Mar. 4, 2009, that would allow pharmacists and wholesalers to import prescription drugs from Australia, New Zealand, Japan, Switzerland, and the European Union. The bill’s cosponsors claim that Americans pay as much as 5 times more to fill their prescriptions than consumers in other countries and that “promoting competitive market pricing would both contribute to healthcare savings and allow greater access to therapy.”
If the bill, S. 525-Pharmaceutical Market Access and Drug Safety Act of 2009, is passed, the Federal Food, Drug, and Cosmetic Act would be amended to waive limitations on registered exporters and importers to allow qualifying drugs into the United States. A qualifying drug is a drug for which there is a corresponding US label drug (i.e., the same active ingredient or ingredients, route of administration, dosage form, and strength, is approved under section 505c and is manufactured by or for the person that manufactures the qualifying drug), according to the proposed legislation.
The bill does not apply to controlled substances, biologics, infused or injected drugs, drugs inhaled during surgery, and sterile ophthlamic drugs intended for topical or eye use. In addition, a drug that is referred to in two or more abbreviated new drug applications cannot be imported under the new proposed legislation.
Although patients may be happy with the proposed legislation, industry has voiced concern over the bill. “It is critical that we maintain our focus on comprehensive health reform to help all Americans access high-quality and affordable healthcare coverage,” said the Pharmaceutical Research and Manufacturers of America in a Mar. 4, 2009, statement. “We should not pursue policies that could expose Americans to substandard drug products and potentially weaken the US Food and Drug Administration by crippling the agency’s ability to fulfill its mission in protecting public health and safety.”