Bulk Pharmaceuticals Task Force (BPTF) advocacy reflects an active role in a continuing dialogue with the Food and Drug Administration (FDA) and other regulatory authorities on issues related to drug safety and quality. This advocacy requires engagement with multiple stakeholders and a multi-faceted approach:

  • BPTF  is a key stakeholder in negotiations with FDA to establish and implement a generic drug user fee program (GDUFA);
  • BPTF keeps members aware of current and impending guidances, regulations and legislation related to active pharmaceutical ingredients and excipients;
  • BPTF routinely provides stakeholder input on proposed FDA and EMA regulations and guidances to ensure that member company concerns  are addressed;
  • BPTF provides Congressional testimony when warranted as important stakeholders in the pharmaceutical industry;
  • BPTF provides input to other pharma stakeholders and industry regulatory groups to reinforce the need for drug safety throughout the supply chain;
  • BPTF has become a trusted voice for generic API manufacturers and is routinely sought out by the press for important information on news impacting industry members;
  • BPTF has developed tools for industry and made them available to assist companies wishing to strengthen their adherence to cGMPs;
  • BPTF has established working relationships with organizations such as Rx-360, IPEC, European Fine Chemicals Group and The PEW Charitable Trusts to collaborate on drug safety and quality initiatives; and
  • BPTF is a member of the Coalition for the Rational Implementation of the USP Elemental Impurities Requirements.

Below are examples of BPTF advocacy:

Food and Drug Administration Comments

Following is a listing of recent comments submitted to FDA on behalf of BPTF member companies:

FDA Petition

U.S. Pharmacopeial Convention (USP) Comments

European Medicines Agency (EMA) Comments

European Commission (EC) Comments

Templates Prepared by BPTF for Industry Use

Congressional Testimony

SOCMA-EFCG White Paper

Priorities Moving Forward - What Lies Ahead?

The Bulk Pharmaceuticals Task Force will continue to develop industry positions and interact with governmental agencies on emerging regulations, legislation and guidelines impacting drug safety and to discuss interpretations of regulations that may impact member companies.  BPTF sponsors and conducts programs of interest to the members and provides networking opportunities for mutual assistance and education.

A key area of interest to BPTF members is the implementation of GDUFA.  It will be important to continue to monitor FDA implementation activities to ensure goals established in GDUFA will be met and to provide assistance to member companies in meeting the requirements of the current five-year program. In addition, BPTF intends to make its collective voice heard during the upcoming reauthorization process to identify and champion those aspects of GDUFA that require change and improvement, and ensure that industry obtains appropriate value for its investment in this user fee program.

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Contact Us

John DiLoreto
Executive Director
(301) 987-0924