Drug Administration

When the federal government approved his home drug-testing kit in January, J. Theodore Brown Jr. thought he had a sure moneymaker.The market for such a kit seemed to be huge: Drug use among teen-agers has risen almost 80 percent since 1992, and school-age youths are using drugs at a younger age than ever.But parents don't seem to be rushing to buy Dr. Brown's Home Drug Testing System, which retails for $42.95 and tests urine for drugs including marijuana, PCP, cocaine, morphine, amphetamines, heroin and codeine.

Four Maryland women filed a class action suit in U.S. District Court in Greenbelt yesterday against the makers and distributors of two controversial weight-loss drugs, alleging the drugs caused health problems that put their lives at risk.Linda S. Higgs of Laurel, Maria Montgomery of Potomac, Judith A. Pino of Bowie and Joann M. Woodward of Annapolis allege that taking fenfluramine and phentermine exposed them to "potentially life-threatening side effects and diseases."Plaintiffs attorney Phillip L. Feliciano said the suit is one of several filed across the country by women who might suffer heart problems from the drugs, often used in a combination known as fen-phen.

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.

FDA letter boosts Univax stockShares of Univax Biologics Inc. rose 24 percent yesterday after the company said it received an encouraging letter from the Food and Drug Administration about its application for a new drug.Shares of the Rockville-based developer of drugs and vaccines closed up $1.375, at $7. Volume was 123,400, almost four times the stock's average daily volume of 32,481.Univax said Thursday that it received a letter from the FDA regarding its application for WinRho SD, a drug used to treat Immune Thrombocytopenic Purpura, or ITP, which causes excessive bleeding, primarily in people with HIV/AIDS and in some children.

Q: Can you explain why it takes so long before a promising new drug is available to patients?A: Perhaps a description of the process for drug approval will explain why it takes so long and costs the pharmaceutical company so much money before a drug is approved by the Food and Drug Administration (FDA). The following steps are involved (all times are approximations).* The pharmaceutical company does laboratory and animal studies to show safety and activity of the drug against a disease. Time: 3 1/2 years.

WASHINGTON -- The French company that makes the abortion pill RU-486 has agreed to license the drug to a U.S. contraceptive research group so it can find a manufacturer in the United States, the commissioner of the Food and Drug Administration said yesterday.The commissioner, Dr. David Kessler, said that after a meeting yesterday in Rockville, Md., Edouard Sakiz, president of the French company, Roussel-Uclaf, agreed to license the drug and the technology to make it to the Population Council, a not-for-profit research organization based in New York City.

WASHINGTON -- The Food and Drug Administration sai yesterday that it would end its ban on women's participation in most drug safety tests and require companies to carry out analysis by sex in virtually all applications for new drugs.The FDA commissioner, Dr. David A. Kessler, said that he would send rules to companies in the next few weeks "saying that women simply must be included and we are lifting the 16-year ban we have had on women in early drug trials."Women have been excluded because it was feared that the fetus would be damaged if they became pregnant during tests.

WASHINGTON -- Inadequate or hard-to-read warning labels on common non-prescription drugs mask potential adverse effects and can endanger consumers, particularly the elderly, members of Congress charge.At a joint hearing yesterday of two congressional subcommittees concerned with health matters, lawmakers said the Food and Drug Administration relied too much on industry to monitor the safety of over-the-counter drugs and charged that the agency had been slow in completing safety and effectiveness studies of many common drugs.

WASHINGTON -- There is still little prospect that Frenc abortion pill RU-486 will be available in the United States soon, despite President-elect Bill Clinton's willingness to encourage the marketing of the drug in the United States.Officials of the Food and Drug Administration and the French company that makes the drug, Roussel Uclaf, agree that whether the abortion pill is sold in the United States depends mostly on top officials of the German company Hoechst AG, which controls Roussel, and how those corporate officials view abortion politics in Germany and the United States.

A Bayshore, N.Y., pharmaceutical firm has been fined $1 million for illegally shipping adulterated drugs and marketing unapproved drugs.Superpharm Corp. pleaded guilty yesterday in U.S. District Court in Baltimore to a four-count criminal information.Evidence presented by U.S. Attorney Raymond A. Bonner showed that the company shipped Diazepam, an anti-anxiety drug, to Maryland and other states after falsifying test data submitted to the U.S. Food and Drug Administration.The company also pleaded guilty to illegally marketing Quinidine Gluconate, which is used to control irregular heartbeats, and Doxycycline Hyclate, an antibiotic, after changing the FDA-approved formula for the drugs.

It's amazing what an hour of aimless channel surfing can turn up these days. After some freewheeling with the remote one night recently, I managed to catch not only half a dozen low-budget makeover shows but also three ads for FDA-approved pharmaceuticals: one for depression, another for premenstrual dysphoric disorder and a third for inadequate eyelash syndrome - sorry, "eyelash hypotrichosis." Prescription treatment for "longer, thicker and darker lashes?" Fellow Americans, have we lost our minds?

Rental property law protects communities Councilman T. Bryan McIntire's opposition to the new Baltimore County rental law is well-intentioned but unfounded ("Most Balto. Co. rental properties conform to new law," Feb. 8). Towson University fails to provide housing for about 30 percent of its students. And the surrounding communities suffer as a result of its campus housing shortage. Don Gerding, the chairman of the Rodgers Forge External Affairs Committee, and I have frequently reported problems with rental housing in the area to housing code enforcement authorities and county police.

OK, so you're hungry and rooting around in the fridge, or maybe the pantry, and find something. You think you've stumbled upon it - What's this? Chocolate? Yes! - when it dawns on you: You can't remember buying the bar. Or when you first opened it. What now? Should you eat it or toss it? What if it's milk? Or medication? How long will that stuff keep, and what's at stake after you pass that point? For many things, your budget and personal preference can dictate how often you replace them, but for others, it's a safety issue.

The Rev. Eddie Martin was willing to take two drugs, a diuretic and a calcium channel blocker, to get his blood pressure down. But when his doctor decided to add a third pill, a cholesterol-lowering medication, to Martin's daily medicine regimen, the reverend balked. "I just hate taking pills," Martin says, "and what's more, with each extra drug, that's another co-pay I've got to shell out." Then the Woodland, Ohio, resident heard a TV ad for Caduet, which combines the blood-pressure-lowering drug Norvasc with the cholesterol-reducing medicine Lipitor.

WASHINGTON -- This year's spending plan for the Food and Drug Administration, National Institutes of Health and Social Security Administration, crafted by the new Democratic majority in Congress and signed into law this week by President Bush, provides a mix of good and bad news for the Maryland-based agencies, according to congressional aides and other government officials. The National Institutes of Health, which funds much of the country's medical research, including hundreds of millions of dollars each year to Johns Hopkins and the University of Maryland, received $28.9 billion, a $620 million increase over last year.

Did you know?--One in 1,000 Americans develops blood clots, or deep vein thrombosis, after traveling on long flights each year. - Food and Drug Administration

The Food and Drug Administration will let researchers test small amounts of experimental drugs on people at a much earlier stage than previously allowed, under guidelines announced yesterday. The new rules are meant to help identify drugs that won't be approved before too much time and money are expended, federal officials said. Health and Human Services Secretary Michael O. Leavitt said, "The recommendations ... will help more researchers conduct earlier, more-informed studies of promising treatments."

WASHINGTON -- President Bush's new Food and Drug Administration chief could face a built-in conflict of interest if he follows through with his plan to keep his present position as head of the National Cancer Institute while also taking over the FDA, some leading physicians and consumer activists caution. Dr. Andrew C. von Eschenbach expressed confidence this week that he can do both jobs well. But because the FDA has an oversight role in the cancer institute's drug development research, some experts foresee problems - especially since von Eschenbach is publicly committed to accelerating approval of some anti-cancer drugs.

ANGLETON, Texas - Jurors held drugmaker Merck & Co. liable yesterday for the heart-related death of a 59-year-old marathon runner who took its prescription painkiller Vioxx, awarding his widow $253.4 million. It was a staggering loss in the first of 4,200 suits that have been filed against Merck, and it could have far-reaching implications for the pharmaceutical industry, which has been under fire in recent months for its aggressive marketing tactics. Merck pulled Vioxx, which was being taken by 20 million people, from the market in September after a study found that its use increased the risk of heart attack and stroke.

WASHINGTON - The government's "fast track" system for making new medications quickly available to treat the deadliest illnesses has become a route for companies to market drugs without fully proving their effectiveness or safety - either before or after they go on the market, says a congressional report to be released today. The report found that pharmaceutical companies receiving accelerated approval from the Food and Drug Administration often fail to follow through on promises to do complete field trials and other studies after their drugs reach the market.