FDA Considers Revamp of Drug Rules

WASHINGTON – The Food and Drug Administration is poised to revamp rules for safe drug manufacturing for the first time in 25 years, reacting in part to companies' desire to automate pill production and the government's own inability to inspect factories as rigorously as it once did.

The FDA's planned update comes even as numerous major medical factories have repeatedly failed to meet current standards of quality manufacturing.

Just last week, the FDA ordered a Georgia tissue bank to recall soft tissue grafts because it couldn't guarantee they were free of bacterial contamination. Drug maker Schering Plough recently agreed to a $500 million FDA fine for quality-control violations; Eli Lilly & Co. last month said factory problems could delay as many as five drugs under FDA review; and Abbott Laboratories in 1999 paid a $100 million fine in agreeing to clean up its plants.

The FDA said its changes will modernize the way it inspects medical factories -- ultimately focusing most on those that make the riskiest products -- and allow pharmaceutical companies to make better use of new technology that could improve quality.

"There's a tremendous scientific and technological opportunity here, and we need to embrace that and help the industry embrace it," FDA drug chief Dr. Janet Woodcock said Wednesday.

For example, she cited fully automated manufacturing systems that some U.S. drug makers use in factories in Europe and other countries -- but not here -- that contain sensors embedded in different steps. Those sensors could tell if a batch of pills or powders has an ingredient wrong, for example. So can FDA-required laboratory testing of a few pills here and a few pills there, but a sensor may provide continuous, immediate quality control, Woodcock said.

The FDA likes the promise of that technology, but drug makers recently told agency officials that they believed the government's 25-year-old manufacturing rules made it too hard for them to adopt it in their U.S. factories. As a first step in its planned update of "good manufacturing practices," the FDA already has begun streamlining how companies can adopt such technology, Woodcock said.

The Pharmaceutical Research and Manufacturers of America, the industry's trade group, welcomed Wednesday's announcement, saying FDA's development of new manufacturing standards "will help ensure that patients continue to benefit from timely access to high-quality" drugs.

But Larry Sasich of the consumer advocacy group Public Citizen called the plans "very, very troubling."

He questioned whether FDA was loosening some standards simply because it has run out of money to inspect medical factories frequently, and asked how technology could really be transforming the industry when so many factories have recently run into trouble. "It just doesn't add up."

Last year the FDA inspected 1,600 factories for compliance with good manufacturing practices, down from 4,300 in 1980, Woodcock said. The reason: Even as the number of drugs FDA oversees has increased, Congress has not increased funding for regular inspections to ensure those medications aren't contaminated and contain the proper, safe level of ingredients in each batch.

The FDA's update won't loosen standards but strengthen them so "we'll be able to allocate inspections better based on risk," said enforcement chief John Taylor.

The update is expected to take several years to complete; companies must follow the old rules until then.