“The U.S. House of Representatives has taken a crucial step to make our nation’s drug safety system — which already is the best in the world — even better,” said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America.  The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers.  “It is the mother of all F.D.A. reauthorization bills,” said Dan Troy, a former general counsel for the drug agency who represents drug makers.  Even with all of these provisions, however, the bill does not address every controversial issue involving the agency.  Just Tuesday, cancer patients marched outside F.D.A. offices to protest the agency’s decision not to approve Provenge, a drug for prostate cancer. The legislation passed Wednesday does nothing to address calls by some patient advocacy groups for the agency to allow the sale of some drugs while they are still being researched.  Nor does the bill do much about concern over the safety of imported foods beyond creating a registry of adulterated foods and a statement that Congress “should work to develop a comprehensive response to the issue of food safety.”  Followers of the drug agency’s activities said the bill was so complicated that it would take time to sort through it.  “It’s a Christmas tree with more moving parts than you can imagine,” said Peter Barton Hutt, a former F.D.A. general counsel.  The House vote, 405 to 7 for approval, came after an all-night negotiating session over a few sticking points, and it came almost exactly three years after the withdrawal from the market of Vioxx, a pain pill that was found to increase the risk of heart attacks and strokes.  The Vioxx withdrawal kicked off an intense period of scrutiny for the drug agency that resulted in development of many of the bill’s most important provisions. One of those is a projected increase to $400 million — up about 25 percent — that drug makers must pay to finance agency operations. Fees for makers of medical devices will also increase. The bill would expand the scope of what the agency can do with that money.  Drug makers would be required to post publicly the results of all clinical trials involving approved medicines. This provision is in response to controversy about a set of clinical trials kept secret by the industry that revealed that antidepressants increased the risks of suicide in teenagers while doing little to treat their depression.  The bill would also grant the agency the power to require drug makers to undertake clinical trials of medicines that the agency has already approved and to fine those who fail to do so. Few drug makers have followed through on past promises to undertake such trials, and the drug agency has done almost nothing about these failures.  The legislation would also grant the agency the authority to force drug makers to change the labels on their products, and it would give the agency the power to limit the distribution of certain drugs.  It would require the agency to reduce the number of conflict-of-interest waivers it grants to experts who serve on its advisory boards.  A version of this article appears in print on , on Page A18 of the New York edition with the headline: House Passes Bill Giving More Power To the F.D.A. Order Reprints| Today's Paper|Subscribe
The bill is expected to give federal drug regulators significantly more money and power to ensure the safety of the nation’s drug supply.