Fda

When Dr. David Kessler took over recently as the new head of the federal Food and Drug Administration, he inherited a budget -- $690 million -- that virtually matched that of his previous institution, the Albert Einstein Hospital in New York, where he had been chief of medicine. But there's a big difference in what those budgets must cover. Unlike a hospital, the FDA wields vast power, with its responsibility for the safety and quality of goods that make up one-quarter of the nation's gross national product.

In their zeal to trim the federal bureaucracy and reduce heavy-handed regulation, Republican leaders in Congress need to tread carefully. Just because an agency like the Food and Drug Administration doesn't approve new products as swiftly as corporate marketing departments would like is no reason to cripple an agency that performs a vital function -- often as vital as the difference between life or death.Sun Washington Correspondent Michael A. Fletcher reports that the incoming speaker of the House, Newt Gingrich, thinks the FDA should be "torn down" because it is "the leading job killer in America."

If practice makes perfect, the Food and Drug Administration may finally be on its way to regaining confidence in its ability to protect public safety. The conflict-ridden agency - both shill for the pharmaceutical industry and stooge for White House political shop - can hardly afford any more steps backward. In naming veteran FDA official Kathleen Uhl to head the office of women's health, the Bush administration has at least met what would seem to be the minimum requirements for the post: She is a woman and a physician.

Important questions remain about the Food and Drug Administration, despite the aggressive approach its new commissioner, Dr. David A. Kessler, has taken on truth-in-promotions. The first has to do with efficiency, a buzzword during the Reagan-Bush years.It has been well documented that approval of new pharmaceuticals drags. In the competitive environment in which American manufacturers find themselves, that means new products often get introduced abroad before U.S. approval can be won, even if the drugs were developed by domestic firms.

PharmaKinetics Laboratories Inc., a Baltimore-based generic-drug development company, said yesterday that it has been warned by the Food and Drug Administration that it is in violation of guidelines governing drug testing.The FDA said in a Dec. 28 letter to the company that PharmaKinetics had failed to follow established rules for drug tests involving people. Specifically, the federal agency criticized the company for failing to document the medical reasons for including in tests in 1990 and 1991 people who did not meet the company's own criteria for such volunteers.

PHILADELPHIA -- In a widely expected move, Merck & Co.'s arthritis drug Arcoxia was rejected by U.S. regulators yesterday amid concerns that it could pose some of the same cardiovascular risks as the company's withdrawn pain-reliever Vioxx. The Food and Drug Administration said it wanted more data showing that the benefits outweighed potential risks before approving Merck's successor drug to Vioxx, the company said. Merck said the FDA issued a "non-approvable" letter for Arcoxia stating that "Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval."

BOSTON -- The Food and Drug Administration, which two years ago simplified food labels, is now seeking to do the same for drugs. The agency proposed yesterday that patients get clear and simple information sheets about every drug with every new prescription.For about half of the more than 900 million new prescriptions written in the United States each year, patients get no package information about side effects or the dangers of combining the drugs with others.Yesterday, the secretary of health and human services, Donna E. Shalala, announced the plan, which would require pharmacists to provide written information to 75 percent of patients getting new prescriptions by the year 2000, and to 95 percent by 10 years after such a rule went into effect, most likely next year.

WASHINGTON -- Food and Drug Administration officials defended the agency yesterday against charges that import restrictions on the abortion-inducing drug RU-486 are a response to political pressures by anti-abortion activists, saying the FDA stands ready to approve import of the controversial French drug for legitimate medical research.FDA representatives appearing at a House small business subcommittee hearing denied charges that limits on the import of RU-486 were depriving U.S. medical researchers of access to the drug, which could be useful in fighting breast cancer and other diseases.

WASHINGTON -- A task force set up by the pharmaceutical industry called on the Food and Drug Administration yesterday to revamp the approval process for new generic drugs and beef up enforcement against drug testing fraud to help restore public confidence in the generic drug industry.The private review board, formed in the wake of revelations two years ago that several generic drug firms had bribed FDA officials and had supplied false information to them to win approval for their products, said they wanted the FDA to guarantee the integrity of the testing process.

WASHINGTON -- The Food and Drug Administration is re-examining the rules that govern appointments to its panels of outside experts that recommend whether the agency should approve new drugs for sale, an FDA official said yesterday. Liberal interest groups have attacked the scientific integrity of the FDA's advisory panels, saying the agency has allowed doctors and scientists to serve on them despite their ties to companies with financial stakes in the committees' actions. Dr. Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs, said the agency wants to clarify the reasons for allowing an expert to serve when there are conflicts of interest and the circumstances for publicly disclosing such waivers.