SOCMA Petitions FDA to Increase Inspections of Offshore Drug Manufacturing Facilities

Washington, DC (Sept. 22)––The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, www.socma.org) submitted a citizen petition to the US Food and Drug Administration (Washington, DC, www.fda.gov) requesting that the agency increase inspections of drug manufacturing facilities located outside of the United States. SOCMA is the US-based trade association representing batch and custom manufacturers.

In filing the citizen's petition, SOCMA asserts that nearly half of all drugs marketed in the United States are produced or manufactured in foreign facilities, but that the vast majority of FDA inspections occur domestically. “And with the FDA facing budget cuts, most foreign facilities are not likely to ever be inspected,” said SOCMA, in a release.

BPTF and SOCMA are requesting that FDA better manage the public health risks associated with the use of active pharmaceutical ingredients (APIs) manufactured or processed in foreign facilities. The petition outlines recommendations for improving FDA’s ability to reduce the risks from drug products imported into the United States. “Currently, the FDA inspects facilities according to a risk-based formula that weighs a variety of factors,” said SOCMA in a release. “Being a foreign facility is not a factor in the formula.” Based on that finding, the BPTF is making three recommendations in the petition:

• Ranking foreign and domestic drug manufacturing firms together to allow for better comparisons of the risks from foreign and domestic manufacturers;

• Listing “foreign facility” as a significant risk factor for determining facility inspections;

• Creating a program to monitor the impurity profiles of imported over-the-counter drugs for patterns creating the appearance of underlying problems in complying with current good manufacturing practices to allow FDA to refuse entry to products appearing adulterated.

The petition may be found at: http://www.socma.org/PDFfiles/NewsReleases/BPTF_Citizens_Petition_Foreign_InspectionFINAL.pdf