FDA Announces Plans To Revise Rules for Inspections of Drug Manufacturing Plants

In response to several recent manufacturing problems that have prompted drug recalls, the FDA yesterday said that it plans to "revise the way ... inspectors monitor the so-called good manufacturing practices" used in pharmaceutical factories, the Wall Street Journal reports. Although the announcement was "short on specifics," the FDA said it will hold meetings with drug industry groups to review its current guidelines and to ensure that "standards are applied consistently" and resources are "used most effectively and efficiently" to address the most significant health risks (Adams, Wall Street Journal, 8/22). The number of drug manufacturing plants inspected annually by the FDA has decreased in recent years, from 4,300 in 1980, to 1,600 in 2001, largely because Congress has not increased the agency's budget for inspections despite a rise in the number of drugs needing regulation. As a result of the less-frequent inspections, the FDA has increasingly discovered manufacturing violations at drug makers' facilities, including those of Schering-Plough Corp., Eli Lilly & Co. and Abbott Laboratories (Neergaard, AP/Chicago Tribune, 8/22). Kenneth Shelin, a former FDA official who helped craft the current guidelines, said that the agency's "intense focus" on drug company mergers and acquisitions in recent years has resulted in less attention on manufacturing concerns, the Journal reports (Wall Street Journal, 8/22).

According to Janet Woodcock, director of the FDA's drug division, the "first step" in the agency's revision of regulations will be to streamline the process drug makers use to adopt new quality-control technology, such as fully automated manufacturing systems that include sensors to detect production problems (AP/Chicago Tribune, 8/22). Another outcome of the review might be greater agency focus on "risk-based" inspections, under which the FDA would have more flexibility to inspect factories that manufacture products that carry greater health risks, like prescription drugs, more often than factories that produce common goods such as toothpaste (Wall Street Journal, 8/22).

The review, which is the first "major" analysis of the FDA's manufacturing rules in 25 years, is not expected to be completed for at least two years. The agency will continue to enforce current manufacturing standards and review procedures during that time, FDA Deputy Commissioner Lester Crawford said (Dooley, Bloomberg/Boston Globe, 8/22). However, Woodcock said that in an effort to increase the consistency of manufacturing standards, FDA officials will immediately begin reviewing all warning letters that district officers send to drug companies. Officials at the Pharmaceutical Research and Manufacturers of America reacted favorably to yesterday's announcement and said they would work with the FDA to help revise regulations. "At times, the regulations have been difficult for the industry to fully understand," John Kelly, PhRMA's senior vice president for scientific and regulatory affairs, said (Wall Street Journal, 8/22). But Larry Sasich of Public Citizen said the FDA's initial plans to change manufacturing guidelines are "very, very troubling." He said the agency wants to revise its standards because it has run out of money and cannot meet current regulations (AP/Chicago Tribune, 8/22).