Re “Prescription for trouble,” editorial, March 25
It is misguided to compare importation legislation -- which would allow foreign drugs that are not subject to review by the Food and Drug Administration to enter the U.S. -- with active pharmaceutical ingredients (APIs) from foreign sources that are under the jurisdiction of the FDA and subject to intensive scrutiny. Brand-name pharmaceutical companies are required to take many steps to ensure the quality of APIs -- such as conducting their own inspections of API suppliers and testing samples of incoming ingredients -- to comply with the FDA’s strict regulatory standards, protect patient safety and help prevent adulterated APIs from entering our drug supply.
Under pending proposals, however, products that are not FDA approved, not bioequivalent to U.S.-approved products, and potentially substandard and counterfeit products that have circulated in foreign retail distribution streams outside the FDA’s jurisdiction, would be allowed into our country.
Although such incidents are rare, one can only imagine the counterfeit problem America would face if we opened up our closed distribution system as proposed in importation schemes.
The writer is senior vice president of the Pharmaceutical Research and Manufacturers of America.