The Food and Drug Administration (FDA) has implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States.
The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety.
In order to qualify to be in the program, pharmaceutical companies must be the sponsor of a New Drug Application or an Abbreviated New Drug Application, or be a foreign drug maker that has imported a completed drug product. Initially, drug companies can pick up to five drugs to be included in the program.
Drugs that qualify will still undergo random examination of shipments and reviews of records. If a participating drug receives a warning letter about violating the Federal Food, Drug and Cosmetic Act, or if a drug company does not follow the program’s requirements, it will be removed from the program and will have to undergo the time-consuming routine manual drug entry review process.
The Secure Supply Chain Pilot Program is part of a larger program launched by the FDA in 2009 after concerns that many drug manufacturing companies in developing countries are not inspected, which increases the risk that dangerous or ineffective drugs may be imported into the United States.
These concerns first came to light in 2008, when the FDA received reports of serious reactions, including deaths, in patients who were undergoing dialysis. An FDA investigation revealed that that batches of heparin used during the dialysis process manufactured in China were contaminated with oversulfated chondroitin sulfate (OSCS). Since then, the FDA has taken measures to keep dangerous versions of heparin out of the United States, including banning some Chinese manufacturers and asking all FDA-approved makers of heparin to test for OSCS. The agency also opened satellite offices in other countries so that regular inspections of these plants could be conducted.
Source: Law 360