Foreign Sourced Active Pharmaceutical Ingredients vs. Imported Drugs

PhRMA Staff
PhRMA Staff March 12, 2011
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In a 60 Minutes segment airing tonight, Food and Drug Administration (FDA) Commissioner Margaret Hamburg admits that there are rare instances of counterfeit medicines seeping into the closed U.S drug supply but in other countries around the world, patients aren't as lucky nor are they safe from the global counterfeit drug threat.

The Commissioner also talked about active pharmaceutical ingredients, which are critical components that give a prescription drug its therapeutic effect, and therefore helps to cure, mitigate, treat or prevent disease.

Watch Kendra Martello, Assistant General Counsel, PhRMA, explaining the difference between foreign-sourced active pharmaceutical ingredients in FDA-approved medicines and imported drugs from foreign countries that have not been approved by FDA.

Kendra stressed that while a prescription drug may contain an active pharmaceutical ingredient sourced from other locations in the world, it is important to know that FDA's strict regulations apply to all aspects of the drug's manufacture, including the use of all ingredients, both active and inactive, that make up an FDA-approved medicine sold in the U.S., no matter where the ingredients are derived from.

Prescription drugs sold in other countries, however, are very different because they are not FDA-approved and not necessarily safe for consumption by U.S. patients.

Topics: FDA, Counterfeit Drugs, Importation