FDA

WASHINGTON -- The federal government proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices. The Food and Drug Administration said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.

WASHINGTON -- Federal health officials proposed new label warnings for all antidepressants yesterday, a move aimed at protecting 18- to 24-year-olds who might be at increased risk of suicidal thinking and behavior during early months of treatment. The "black box" update would follow similar changes made to antidepressants' labels in 2005 that added a warning of increased suicide risks among children and adolescents but did not give specific ages. The Food and Drug Administration emphasized that patients who are advised by their doctors to take an antidepressant should not stop using the drug.

WASHINGTON -- President Bush proposed yesterday that the government's powers to prevent the sale of unsafe food, toys and other imports in the United States be vastly expanded, including the stationing of inspectors abroad and the authorization of food recalls. Bush called for tougher inspections of the riskiest imports, companies and countries, as well as steeper fines for violators. Under the president's proposal, the Food and Drug Administration would have the power to recall tainted food, instead of having to persuade companies to act. "The American people expect our system of import safety to be strong and effective, and we will continue working to make sure that it is," Bush said, presenting the 86-page plan.

WASHINGTON -- The federal government has repeatedly reprimanded drug companies in recent months after finding that they had made false or misleading claims in television commercials and magazine advertisements for a wide range of prescription drugs.Such advertising has exploded as drug companies market their products directly to consumers. The government is scrambling to keep up with Madison Avenue.In the past year alone, the Food and Drug Administration has admonished companies about commercials advertising drugs for allergies, asthma, high cholesterol, high blood pressure, hair loss and sexually transmitted diseases.

More than 10 years after a Food and Drug Administration committee introduced the concept of informed consent for approved drugs, the agency's officials still don't know if their strategies for issuing drug warnings are working.And critics say the FDA's uncertainty is just one more symptom of an entire system in shambles."The recommendations are out there, and the FDA can point to them on paper," said Bruce Psaty, an associate professor of medicine at the University of Washington. "But what's the evidence that they work?"

WASHINGTON -- The House voted yesterday to bar the Food and Drug Administration from spending federal money to test, develop or approve any drug -- including the French abortion pill RU-486 -- that would chemically induce abortion.By a vote of 223-202, lawmakers amended the fiscal 1999 agriculture spending bill to include the ban, then overwhelmingly approved the $56 billion agriculture bill. Thirty-five Democrats joined 188 Republicans in voting for the anti-abortion measure.Advocates of abortion rights swiftly attacked the move, although even the sponsor of the amendment, Rep. Tom Coburn, conceded it was unlikely to be approved by the Senate.

Releasing its own survey of doctors who work for the Food and Drug Administration, an advocacy group accused the agency yesterday of lowering its standards for safety and efficacy, working too hastily and approving drugs that should never have been allowed on the market.The report drew a scathing rebuttal from the drug industry, an oblique defense from the agency and criticism from representatives of chronically ill people who advocate swifter drug approval.But some scientists said the report raised significant concerns.

MedImmune Inc. yesterday won government go-ahead to market its new drug for a potentially life-threatening respiratory disease in premature infants and young children.Synagis, which was approved for sale by the U.S. Food and Drug Administration, was developed to prevent serious respiratory syncytial virus, or RSV, a disease that causes pneumonia and bronchitis and is especially serious for premature infants.According to MedImmune, 4,500 children in the United States die of RSV every year and 85,000 are hospitalized for it."

WASHINGTON -- The Food and Drug Administration dismissed explicit warnings of danger as the agency raced to approve a new diabetes drug that has been linked to at least 33 deaths from liver injuries, records and interviews show.Senior FDA officials reviewed the drug on a "fast track" while playing down harmful potential side effects. The drug, a diabetes pill called Rezulin, has become a sales sensation since it was launched in March 1997 by Warner-Lambert Co., a major U.S. pharmaceutical manufacturer and maker of consumer products such as Dentyne chewing gum.The first reported deaths from liver failure prompted the withdrawal of Rezulin one year ago in Britain.

IMAGINE a war on crime in which nobody knew how many murders occurred or a Federal Aviation Administration that was unaware of how many airplanes had crashed. Suppose we were so casual about fatal automobile accidents that it was not even necessary to report one.This is how we monitor the risks of prescription drugs, although they account for more deaths each year than murders, auto accidents and airplane crashes combined.It is estimated that more than 100,000 people die every year from the adverse effects of prescription drugs, and 1 million are injured so severely they require hospitalization.

More than 150 years ago, Baltimore's port inspector saw Europe's poorest-quality drugs being dumped on the United States. He knew substandard medicines hurt soldiers abroad and wanted to defend citizens at home. Port inspectors, doctors and pharmacists demanded higher standards for drug safety. As a result, the United States has the safest drug use system in the world. Sen. Barbara A. Mikulski and her colleagues on the Health, Education, Labor, and Pensions Committee recently defended drug safety and protected patients by demanding that any effort to obtain drugs from abroad have the secretary of health and human services' guarantee that it would protect patients and save money.

Federal regulators won a permanent injunction this week barring a Westminster drug company and its New Jersey parent from selling more than 50 unapproved medications, mostly prescription cough and cold products. The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court on March 25 claiming that Maryland's Neilgen Pharmaceuticals, which does business under the name "Unigen," and its owner, Advent Pharmaceuticals, were selling drugs that were improperly manufactured, carried inadequate directions for use and were not FDA-approved.

Baltimore's health commissioner, Dr. Joshua M. Sharfstein, is headed to Washington to help reform the troubled Food and Drug Administration. That's a major plus for President Barack Obama and a great loss to Mayor Sheila Dixon, who found in Dr. Sharfstein a public health official as attuned to confronting the violence on the city's streets as fighting for the removal of lead-painted jewelry that could potentially sicken its children. Dr. Sharfstein, who led the Obama administration's transition team for the FDA, will serve as chief deputy to Dr. Margaret A. Hamburg, a former New York City health commissioner who would lead the agency.

CORNELIUS, N.C. - In the waning days of the Bush administration, the Food and Drug Administration completed new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients. The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing.

In the waning months of the Bush administration, the Food and Drug Administration is asking the courts to extend the Republican Party's anti-regulatory zealotry well beyond the president's last day in office. This week, the U.S. Supreme Court heard arguments on whether a woman who lost an arm after being improperly injected with a drug could sue the company that manufactured it, and the administration was on exactly the wrong side of the issue. The case involved musician Diana Levine, who was given the anti-nausea drug Phenergan, made by Wyeth Pharmaceuticals, after she visited a Vermont clinic in 2000 seeking relief from a migraine.

Shares of Vanda Pharmaceuticals fell 73 percent yesterday to its lowest level since going public two years ago after the Rockville company said the U.S. Food and Drug Administration rejected its schizophrenia drug, known as iloperidone. In a letter to the company, the FDA said it would require two additional clinical trials for approval, one to test iloperidone's efficacy in conjunction with another drug and one to gather more safety data. During a conference call yesterday, Vanda Chief Executive Officer Mihael H. Polymeropoulos said that would be impossible.

WASHINGTON - Health and Human Services Secretary Michael O. Leavitt, who has been working to open Food and Drug Administration offices in China, said yesterday that he believes a similar office should be opened in Central America. Leavitt, emphasizing that he was not conveying administration policy, said that he believes the FDA should station inspectors in Central America because of the region's leading role in supplying fruits and vegetables to the United States. The secretary plans to discuss the issue, as well as other possible steps to improve the safety of food shipments, with counterparts from El Salvador, Guatemala, Panama and other Central American countries at a conference scheduled for next month.

WASHINGTON - Two government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced yesterday a joint venture that promises to improve prescription drug safety for Americans, while potentially reducing wasteful spending on medications. The Food and Drug Administration and Medicare agreed on rules for using information from Medicare's giant claims databases to create a computerized early-warning network for problems with medications and medical devices that come to light after they go on the market.

WASHINGTON - A Columbia drug company and its top executives have agreed to stop making prescription cough and cold products after repeated failures to pass federal inspections and get government approval of the medicines. Scientific Laboratories Inc. Chief Executive Officer Amit Roy and President Rajeshwari Patel signed a consent decree in U.S. District Court in Baltimore earlier this month. The company had been making various drugs for other pharmaceutical companies, which then sold the products under their own labels.

WASHINGTON -- Citing contamination of drugs, pet food and toothpaste from China, members of Congress have endorsed funding for more federal safety inspectors and to police overseas suppliers. Dr. Andrew C. von Eschenbach, commissioner of the Food and Drug Administration, agreed that the agency needs more resources and for the first time accepted estimates, albeit tentatively, that an additional 500 inspectors and $70 million in funding was required to bolster foreign drug inspections. The emerging consensus, voiced yesterday at a House subcommittee hearing, comes a day after the FDA said as many as 81 Americans died after taking a popular blood-thinning drug tainted somewhere in China with an unapproved chemical.