FDA COMPLETES FIRST STEPS OF ITS BROAD INITIATIVE TO IMPROVE REGULATION OF PHARMACEUTICAL MANUFACTURING

The Food and Drug Administration (FDA) today announced that it has accomplished the initial objectives set in its ongoing initiative to modernize the agency's regulation of pharmaceutical manufacturing and product quality.

This initiative is part of Health and Human Services Secretary Tommy G. Thompson's broader efforts to improve and streamline the regulatory process in order to improve Americans' access to quality health care and services. Two years ago, Secretary Thompson created an HHS-wide initiative on regulatory reform to conduct an ongoing review of HHS regulations and to oversee changes in regulations and appointed an expert advisory panel that made hundreds of specific recommendations. Today's action reflects the Secretary's goal of smart regulation.

"Using state-of-the-art approaches in FDA's many critical review and inspection activities will encourage innovation and continuous improvement in drug manufacturing to minimize production problems, and that will make it easier to get safe, high quality medications to patients who need them," said Mark B. McClellan, M.D., Commissioner of Food and Drugs. "These initiatives are part of the Department of Health and Human Services' overall efforts to improve the quality, safety, and cost of medical products. We will focus our attention and resources on the areas of greatest risk, with the goal of encouraging innovation that maximizes public health protection and promotion."

Today's announcements are a significant interim step in a major agency-wide initiative on "Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach," a two-year program which applies to pharmaceuticals, including biological human drugs and veterinary drugs.

The initiative, announced in August 2002, was designed to evaluate and improve upon the agency's approach to reviews and inspections related to the manufacturing of human and animal drugs and biologics.

Highlights of what's been completed to date include:

• clarifying the scope of FDA's electronic submission and record-keeping requirements and providing for enforcement discretion in certain areas while FDA considers whether to revise the Part 11 regulations to facilitate innovation for modern manufacturing, electronic record keeping, and regulatory submissions;
• facilitating continuous improvement and innovation in manufacturing by allowing manufacturers to make certain types of changes in their processes without prior FDA approval;
• launching a program to identify and address inconsistencies across program areas with respect to all drug cGMP warning letters;
• issuing for public comment a progress report on improving dispute resolution procedures to facilitate early resolution of scientific and technical disputes and allow for greater transparency;
• clarifying the language used to communicate deficiencies observed during cGMP inspections to better describe the purpose and effect of the investigator's observations issued at the conclusion of an FDA inspection;
• planning public workshops on the scientific foundations of the initiative that will help shape the FDA's next steps in its implementation;
• focusing FDA resources on inspections that are likely to achieve the greatest public health impact (e.g., sterile drug manufacturing);
• providing a progress report that considers adding product and technical specialists with relevant expertise to inspection teams that do not yet include such specialists, a promising step for improving the technical quality and consistency of FDA's inspections; and
• enhancing the agency's expertise in pharmaceutical technologies by hiring a number of additional experts and collaborating actively with academic groups and other outside experts.

The "Pharmaceutical cGMPs for the 21st Century" initiative will include additional intermediate and long-term steps. The major goals of the initiative include:

• ensuring that state-of-the-art pharmaceutical science is utilized in the regulatory review and inspection policies;
• encouraging the adoption of new technological advances in high quality and efficient
  manufacturing by the pharmaceutical industry;
• assessing the applicable cGMP requirements relative to the best quality management practices;
• strengthening public health protection by implementing risk-based approaches that focus both industry and FDA attention on critical areas for improving product safety and quality; and
• enhancing the consistency and coordination of FDA's drug quality oversight activities.

The initiative is being overseen by an agency steering committee with representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC). Janet Woodcock, M.D., Director of CDER, is the chairperson of the steering committee.

According to Dr. Woodcock, "FDA expects to complete and publish a comprehensive implementation plan for this cGMP initiative by mid-year. These initial accomplishments are the first steps toward achieving FDA's goals for a 21st-century regulatory system for pharmaceutical manufacturing designed to protect the public health and to ensure that safe and effective drugs are available to the American public."

Additional information on the initiative can be found online at www.fda.gov/cder/gmp/index.htm.

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