Washington Editor

WASHINGTON - The FDA intends to catch up with advancing technology and science by implementing a plan to upgrade its system of monitoring the manufacturing facilities that make biologics, drugs and veterinarian products.

This initiative, which includes an element of education for companies, marks the first time in 25 years the agency has looked at an overall modernization of the system that has undergone incremental changes over the years, according to a statement released by the agency.

"I think this has the potential to be a positive change," Wendy Taylor, director of regulatory affairs and bioethics for the Washington-based Biotechnology Industry Organization, told BioWorld Today. "If they can focus on true product quality and safety issues, we see this as a positive step forward and we think it is important to take a risk-based approach to regulating inspections."

Announced by Lester Crawford, the FDA's deputy commissioner, the plan to improve the current good manufacturing practice (cGMP) program calls for the agency to provide additional regulatory attention and resources to areas of manufacturing that pose the most risk. And, it requires the agency to improve the consistency and predictability of its approach to assuring production quality and safety in all facilities.

"The FDA's regulatory and quality control systems for pharmaceutical products have become a gold standard for the world, and we Americans should be proud that the quality of the medicines we have available to us and our animals is second to none," Crawford said in a prepared statement. "Any system can be improved upon, however. With this risk-based, highly integrative cGMP initiative we intend to do just that. We know we can make even a very good system better."

Stumbling blocks within manufacturing facilities are not uncommon. In fact, even larger companies like Eli Lilly and Co., of Indianapolis; Abbott Laboratories, of Abbott Park, Ill.; and Schering-Plough Corp., of Kenilworth, N.J., have had to explain issues at their own facilities.

In the past month, Schering-Plough was fined $500 million for violations at its New Jersey and Puerto Rican plants while Abbott recently reported that one of its plants may not be in conformity with certain FDA standards. And in July, Lilly said it was working with the FDA to resolve manufacturing problems in several of its plants.

The agency, however, has been handicapped over the past two decades due to an increased number of pharmaceutical products and manufacturing facilities, but a decreased frequency in its inspections because of fewer resources.

As part of the modernization plan, the FDA will consider improving its expertise in pharmaceutical technologies by additional training and hiring, as well as including product specialists as part of the inspection teams.

Other plans involve holding workshops and educating the industry on new regulatory approaches.

While the agency hasn't released specific details on how the plan will be designed and implemented, it did say it will solicit comments from industry, academia, government and consumer groups in the decision-making process. Also, the agency will seek consultation from its international counterparts.

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