Washington Editor

WASHINGTON - Drug and biologics companies need not implement a lengthy list of government requirements in order to remain in compliance with new manufacturing initiatives being put in place by the FDA.

In fact, in a conference call with reporters Thursday, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said the new initiatives, announced last August as part of a sweeping overhaul of the agency, are designed to help companies gain a better understanding of agency rules while navigating products through the system more quickly. (See BioWorld Today, Aug. 23, 2002.)

"For example, if a widget company were to continuously improve its manufacturing processes, it could file a comparability protocol to show how its new widgets will be comparable and thus make changes more quickly without waiting for our approval," Woodcock said. "Similarly, other parts of the initiative are aimed at improving the scientific approach to regulations and encouraging the industry to do the same."

When informed by a reporter that many manufacturers believe the agency hasn't kept up with technology and remains behind the eight ball, Woodcock conceded that both the industry and government could use some upgrades.

"We hope by undertaking this initiative, we will help manufacturers really get it right the first time - that's what we mean by efficient and effective pharmaceutical manufacturing," Woodcock said. "This will encourage the kind of manufacturing practices that will decrease recalls and improve efficiency in the manufacturing sector."

Borrowing from a successful biologics program called "team biologics," Woodcock said the pharmaceutical side of the FDA will implement the "pharmaceutical inspectorate," teams of specially trained employees who will spend their time in the manufacturing arena.

As for team biologics, specialized groups of inspectors and investigators formed in 1996 to oversee blood and biologics, a few improvements are in the works, including standardized training and qualifications for core team members, a system to determine team biologics' impact on the industry, and better communications between field offices and headquarters.

And while biologics manufacturing facilities are often inspected twice a year, David Horowitz, director of CDER's office of compliance, said budget constraints have prevented the FDA from paying such attention to human drug and animal drug sites. "As a result, we have realized that we need to concentrate where we will have the greatest public health impact, and one of the ways to do that is to focus on drug manufacturing facilities where noncompliance would have the greatest adverse public health impact," he said.

To that end, he said the agency is developing a method of prioritizing its inspections.

Updates on other initiatives under the plan:

The agency issued a draft guidance, "Comparability Protocols-Chemistry, Manufacturing and Controls Information," which applies to nonprotein pharmaceuticals and veterinary drugs. Mary Malarkey, director of the division of case management of the Center for Biologics Evaluation and Research, said use of a comparability protocol allows manufacturers to implement changes to their processes without submission of a prior approval supplement to the FDA.

Clarification of the scope of the FDA's electronic submission and record-keeping requirements. Also, the agency has issued a draft guidance (seeking comments from the public) regarding revisions to Part 11 of the regulations to facilitate innovation for modern manufacturing, electronic record keeping and regulatory submissions.

Beginning March 1, all drug current good manufacturing practice (cGMP) warning letters will be reviewed by the relevant center in Bethesda, Md., as opposed to a district office. Frederick Blumenschein, chief, case management and guidance branch at CDER, said this change is expected to "centralize the review of all warning letters which we in turn believe will help ensure continuity in policy."

The FDA will hold a workshop in Washington April 22-24 to discuss a number of the issues, including risk-based cGMP, post-approval manufacturing changes and manufacturing sciences. For more information visit the agency's website at www.fda.gov.