WASHINGTON-When the dust cleared, it was hard to tell whether the first major overhaul of the FDA in 30 years involved construction or demolition. Drug and device makers cheered new streamlined processes, predicting they’d quicken the FDA’s reviews by 10 to 16 months.   Some patient and consumer groups were pleased, but others called it a serious blow to public health, predicting insidious disasters that will make the diet-drug recall look mild.   “The thrust of the law is to weaken the control of the FDA over the marketing of drugs and devices,” says Dr. Arnold Relman, editor-in-chief emeritus of the New England Journal. He condemned provisions that will allow industry to disseminate peer-reviewed articles on off-label uses to doctors and others. “Just because an article is published in the peer-reviewed literature doesn’t mean it’s reliable,” says Dr. Relman.   But Sen. Bill Frist (R-Tenn.), a thoracic surgeon who championed the off-label provision, says the new law includes safeguards that will protect the public from unscrupulous drug and device marketing.   The reform act that the President signed contains more moderate revisions than those previously pushed by the GOP. They would have given the FDA six-month deadlines for reviews, followed by automatic licensure if the products had already been okayed in Europe.   The new law reflects several changes sought by Sen. Edward Kennedy (D-Mass.), who three times threatened to filibuster over provisions he didn’t like. In the end, Ken-nedy called the passage “a victory.”   Dr. Michael Friedman, who heads the FDA on an interim basis while the White House seeks a successor to Dr. David Kessler, says the act “offers several grounds for satisfaction.” For example, it builds on the agency’s recent progress in expediting access to drugs and devices, he says.   About one provision, there was unanimous acclaim. The act reauthorizes user fees for another five years. The fees have enabled the FDA to cut drug-review times roughly in half by hiring additional reviewers. The Pharmaceutical Research and Manufacturers of America said user fees had been its top priority.   PhRMA was also happy that the bill gives the FDA new authority to accept one clinical trial, instead of two, to support evidence of efficacy. But Dr. Relman blasted this on the grounds that one study is “never enough-with extremely rare exceptions, you need at least two.”   The act expands “fast-track” approval, from agents for AIDS or cancer to any serious or life-threatening diseases. It also clarifies FDA rules on investigational therapies and diagnostics outside clinical trials for patients with life-threatening conditions. And it creates an incentive for research among children-an extra six months’ patent exclusivity.   Former Sen. Howard Metzenbaum, now chairman of the Consumer Federation of America, called it “a dark day for the American consumer.”   Charging that the bill was steamrolled through Congress without adequate guidance from consumer and patient groups, CFA praised one “small victory for patients”-the requirement that sole manufacturers of vital drugs give six months’ notice before discontinuing production.   Public Citizen deplored that tracking and postmarket surveillance of high-risk implantable devices became optional. Maura Kealey, a Public Citizen legislative advocate, says the U.S. will have “tougher laws to recall defective car parts than heart valves.”   Some consumer groups also denounced a pilot program that will allow third-party reviewers-FDA-accredited and industry-paid-to review safety and effectiveness studies of devices, except for class III and implantable devices. “I can’t see how people can say with a straight face that there won’t be conflicts of interest,” says Dr. Relman.   But the Health Industry Manufacturers Association says that by loosening the reins on regulation of low-risk devices, the law will enable the FDA to focus its constrained resources on high-risk products.   Dr. Ray Woosley, a Georgetown pharmacologist, says outside reviews are a necessary step, albeit risky, given the pace of technology. He says the FDA always has the last word.   The critics saved their strongest criticism for the off-label provisions. In a letter to President Clinton, Dr. Paul Stolley of the University of Maryland School of Medicine and 73 co-signers noted that it was a peer-reviewed journal article in 1992 that triggered four years of fen-phen enthusiasm among diet doctors.   “Had it been legal for the manufacturer to promote the drugs off-label, the numbers affected would have been much greater,” Dr. Stolley wrote. Instead of allowing off-label promotion, Congress should encourage companies to make wider use of the FDA’s expedited supplemental approval process, the signers said.   The reprints must be from peer-reviewed medical journals or textbooks, and the FDA may add materials for balance. The agency may order a firm to stop dissemination if it fails to comply with the agency’s orders. The companies must also certify to the FDA that within three years they will do the clinical trials needed to get clearance for the indication unless a medical specialty society declares that it is consistent with sound medical practice.   Kealey says that and other exemptions in the law make a mockery of safeguards, calling the exemptions a “virtual roadmap for firms seeking to evade the law.” -Christina Kent