SOCMA: Society of Chemical Manufacturers and Affiliates

This press kit offers information on SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) and the actions it has taken concerning emerging markets product quality. 

Issue
Many active pharmaceutical ingredients (API’s) made in foreign facilities are rarely inspected by the U.S. Food and Drug Administration, especially in the case of ingredients going into over-the-counter drugs.  Under U.S. law, domestic facilities must be inspected before they begin manufacturing.  The majority of foreign facilities manufacturing API’s used in generic medications rarely see an FDA inspector after an initial inspection.  Most foreign manufacturers of over-the-counter medication ingredients have never seen an FDA inspector. 

BPTF first took action in 2006 by submitting a Citizen’s Petition to the Food and Drug Administration calling for increased inspections of foreign facilities  That action was followed by the publication of a joint white paper by BPTF, SOCMA, EFCG. 

Below, are materials the BPTF have made available to the public.  For questions, please contact SOCMA.

About BPTF
SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.  Created in 2002 as an affiliate organization of SOCMA, its primary objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members.

Congressional Testimony

• SOCMA’s Bulk Pharmaceuticals Task Force Asks Congress to Increase Inspections of Foreign Drug Manufacturing Facilities
• SOCMA’s BPTF Testimony to the House Energy  Commerce Committee on FDA Drug Import Inspections Nov. 1, 2007

Press Releases

• SOCMA's Bulk Pharmaceuticals Task Force Unveils Template for Drug API Quality Agreements
• Congressional Hearing on Drug Import Safety - SOCMA’s Bulk Pharmaceutical Task Force to testify
• SOCMA President Joe Acker Expresses Concern Over Emerging Markets Product Quality
• Bulk Pharmaceuticals Task Force Petitions FDA

Petition

• Petition to Request the Food and Drug Administration to Rank Foreign and Domestic Drug Manufacturing Firms Together

SOCMA-EFCG White Paper
This paper discusses the poor quality of the FDA inspection regime and cites a number of figures to demonstrate the FDA's inabilities.

• Uneven Enforcement Leads to Sub-par Drugs and National Security Risk

Executive Summary

• Executive Summary
• Joint Release – US and EU Trade Groups Join Forces to Urge Regulators to Increase Inspections of Foreign Active Pharmaceutical Ingredients Manufacturing Facilities

Templates

• Drug API Quality Agreement
• API Quality Agreement for Custom Manufacturers

BPTF/SOCMA files comments on FDA Science Committee Report: FDA Science and Mission at Risk
The report is an honest look at the issues facing the FDA.

• BPTF/SOCMA Comments on Science Committee Report
• FDA Science Committee Report: FDA Science and Mission at Risk

BPTF files comments to the FDA on Generic Drug User Fees

• Generic Medicines User Fee Comments

News Coverage:

• The Hill - Safer drug supply requires update to our regulation
  Op-ed article by BPTF Chair Patty Benson and Pew Health Group’s Allan Coukell, calling on Congress to take measures to better protect the U.S. drug supply
• Associated Press - Foreign Drugs Get Little Scrutiny
  This article discusses the differences between the rates of inspection
  for foreign manufacturers versus domestic facilities.
• USA Today Letter to the Editor 10/17/07
  SOCMA President Joe Acker wrote a letter to the editor of USA Today in response to an article covering slow progress in protecting U.S. food supply. 
• Lou Dobbs Tonight 10/10/07
  SOCMA’s Lynne Jones Batshon, Representative of the BPTF, was a guest of Lou Dobb’s during his Congress Warns of Dangerous Food Imports from China segment. 
• Pharmaceutical Technology 9/02/07
  SOCMA President Joe Acker submitted this editorial to Pharmaceutical Technology, calling for more FDA inspections on foreign APIs. 
• Washington Post Article 06/18/07
   BPTF Chairman Brant Zell was quoted in this front-page, Washington Post article examining the reasoning for few FDA inspections on India, China.