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To bring a pharmaceutical product to the market in the United States, it must undergo a rigorous process involving approval from the Food and Drug Cosmetic (FD&C) Act of 1938, administered by the FDA. Any drug that fails to meet these established standards is deemed “unapproved” and cannot be imported. Currently, the only legally imported drugs are:
- Those manufactured in foreign FDA-inspected facilities, associated with an FDA-approved drug application, intended for use by U.S. consumers, and imported by the drug manufacturer.
- U.S.-approved drugs that were produced in the United States, sent abroad, and subsequently imported back into the U.S. under exceptional circumstances, such as emergency medical needs or product recalls.
It’s important to note that these regulations pertain solely to the drug products themselves and do not impact the pricing of imported items.
In 2000, the Congress enacted the Medicine Equity and Drug Safety (MEDS) Act, which introduced Section 804 into the FD&C Act. This section allowed pharmacists and wholesalers to directly import prescription drugs from specific industrialized countries, including Canada. However, this importation is subject to specific limitations and safety measures. Importation is permitted only if the Secretary of the Department of Health and Human Services (HHS) can demonstrate that the program carries “no additional risk to the public’s health and safety” and “results in a significant reduction in the cost of covered products to the American consumer.”
The Medicare Modernization Act of 2003 (MMA) amended the importation provisions initially outlined in the MEDS Act. The MMA specifies that wholesalers and pharmacists can only import prescription drugs from Canada, excluding other industrialized nations. Additionally, the MMA grants the Secretary authority to terminate such importation programs if they fail to meet safety standards or do not significantly reduce costs for consumers. The MMA also mandates the issuance of regulations by the HHS Secretary to provide waivers for individuals to import drugs for personal use under specific circumstances.
Importing prescription drugs, as established by the MEDS Act and subsequently amended by the MMA, may allow wholesalers and pharmacists to acquire FDA-approved medications at lower prices from foreign suppliers, ultimately passing on these savings to U.S. consumers.
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