Drug Administration

The most popular prescription sleeping pill in the world was banned in Britain yesterday because of safety concerns, but the U.S. Food and Drug Administration said it had no immediate intention to follow suit.Although the drug, Halcion, has been the focus of a growing debate regarding its side effects over the last two years, health officials in this country were surprised by the British prohibition. They said they knew of no new studies that would shed light on the medication, which has been linked at times with memory loss and violent behavior.

William H. Hoffman, a retired U.S. Food and Drug Administration official, died Monday from septic shock after kidney transplant surgery at the University of Maryland Medical Center. The longtime Ellicott City resident was 81. William Harry Hoffman was born in Baltimore and raised on East Lanvale Street and his grandfather's Owings Mills farm. After graduating from Polytechnic Institute in 1950, he worked briefly as a carpenter's assistant and as a draftsman at Bethlehem Steel Corp.'s Sparrows Point plant, while attending the Johns Hopkins University at night.

A Sinai Hospital cardiologist is launching a clinical trial of a type of coronary artery disease drug not yet tested in humans, building on a history at the Baltimore hospital of research to develop more effective treatments to prevent blood clotting. Dr. Paul Gurbel is studying an intravenous drug for patients undergoing cardiac stenting, when mesh tubes are implanted to widen blocked arteries. The drug, known for now as PZ-128, would be given to patients after stent implantation to prevent platelets from sticking together around the device, potentially leading to heart attack.

A Sinai Hospital cardiologist is launching a clinical trial of a type of coronary artery disease drug not yet tested in humans, building on a history at the Baltimore hospital of research to develop more effective treatments to prevent blood clotting. Dr. Paul Gurbel is studying an intravenous drug for patients undergoing cardiac stenting, when mesh tubes are implanted to widen blocked arteries. The drug, known for now as PZ-128, would be given to patients after stent implantation to prevent platelets from sticking together around the device, potentially leading to heart attack.

Last week, a federal district judge in New York ruled that girls younger than 17 should be allowed to purchase the Plan B contraceptive pill over the counter. Unlike the Obama administration, Judge Edward Korman got this one right. The 2011 decision by Health and Human Services Secretary Kathleen Sebelius to restrict access for younger girls not only denied them a safe and legal means to prevent unwanted pregnancy but ignored all scientific evidence that supported its access. Emergency contraceptive pills, commonly known as "Plan B," are drugs that work to prevent pregnancy if taken shortly after sexual intercourse.

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

To make the brine for Patrick O'Connell's Spruced-Up Turkey recipe that ran in Taste last week, only loose sassafras tea should be used. The bark of sassafras root as a food additive is banned by the Food and Drug Administration.

William H. Hoffman, a retired U.S. Food and Drug Administration official, died Monday from septic shock after kidney transplant surgery at the University of Maryland Medical Center. The longtime Ellicott City resident was 81. William Harry Hoffman was born in Baltimore and raised on East Lanvale Street and his grandfather's Owings Mills farm. After graduating from Polytechnic Institute in 1950, he worked briefly as a carpenter's assistant and as a draftsman at Bethlehem Steel Corp.'s Sparrows Point plant, while attending the Johns Hopkins University at night.

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 -- 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.

Last week, a federal district judge in New York ruled that girls younger than 17 should be allowed to purchase the Plan B contraceptive pill over the counter. Unlike the Obama administration, Judge Edward Korman got this one right. The 2011 decision by Health and Human Services Secretary Kathleen Sebelius to restrict access for younger girls not only denied them a safe and legal means to prevent unwanted pregnancy but ignored all scientific evidence that supported its access. Emergency contraceptive pills, commonly known as "Plan B," are drugs that work to prevent pregnancy if taken shortly after sexual intercourse.

In the early 1980s, transit officials in Washington couldn't figure out why traffic on the Beltway would grind to a near halt every day around the exact same time. The usual explanations didn't fit. Then it was discovered that a single driver was to blame. Every day on his drive to work, this commuter would plant himself in the left lane and set his cruise control to 55 mph, the posted speed limit, forcing those behind him to merge right, and you can imagine the effects. To his credit, this driver came forward in a letter to the editor of The Washington Post.

The staff at Anne Arundel Medical Center considered canceling some surgeries on a recent weekend because the hospital was running low on a common drug used to help bring people out from under anesthesia. It is the kind of problem hospitals and doctors around the country continue to face as drug shortages that began a few years ago threaten the way everyday medicine is practiced. The problem has persisted even after calls from Congress and President Barack Obama to find a solution and a federal investigation that found widespread abuses in the drug manufacturing and distribution system.

The federal Food and Drug Administration identified 89 medical facilities in Maryland that bought drugs from the Massachusetts manufacturer being investigated for a national fungal meningitis outbreak. The facilities are among more than 3,000 in numerous states that the FDA said received drugs from the New England Compounding Center as evidence of widespread sanitary issues at the company continues to come to light. The list of facilities in Maryland covers a large swath of the medical community.

Technicians at the Cape Apothecary compounding pharmacy in Annapolis spend their days mixing drugs that are no longer sold commercially or creating specialized batches of medicine for patients such as children who can't handle the normal dose. Federal officials have linked a compounding pharmacy in New England to a multistate outbreak of meningitis that has infected 119 people, including eight in Maryland. The owner of Cape Apothecary said there is a big difference between his storefront drugstore and the New England Compounding Center in Framingham, Mass.: size.

Federal officials are working to place compassion at the center of how our nation aims to treat elderly patients suffering from dementia. The Centers for Medicare and Medicaid Services (CMS) has announced that they'll coordinate an effort to dramatically reduce the use of antipsychotic drugs among dementia patients in nursing homes. The agency's plan acknowledges that these powerful pharmaceuticals are often overused - and represents a valuable first step toward improving the way we treat people with this condition.

In recent years, pharmaceutical progress has been fast outpacing regulators at the Food and Drug Administration. As a result, potentially life-saving drugs are going unused because the FDA doesn't have enough staff to test them quickly.But disease doesn't wait for product testing, and some people who might otherwise benefit from newly developed drugs are dying. The human cost can't be tallied in dollars and cents, but pharmaceutical companies do put a dollar figure on the losses they incur -- $10 million per drug for each month's delay in FDA approval.

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.

I know how popular those jerky chicken treats are. Around Patterson Park, they're referred to as doggie crack. So I want to pass on this warning from the FDA: The Food and Drug Administration is again cautioning consumers that chicken jerky products for dogs (also sold as chicken tenders, strips or treats) may be associated with illness in dogs. In the last 12 months, FDA has seen an increase in the number of complaints it received of dog illnesses associated with consumption of chicken jerky products imported from China.

Dr. John J. Gibbs, a retired Food and Drug Administration research chemist, died of complications of a brain disorder, frontotemporal degeneration, March 27 at St. Catherine's Nursing Center in Emmitsburg. The former Timonium resident was 73. Born in Troy, N.Y., he was the son of Donald C. Gibbs and the former Mary Loretta McBride. He lived on Mount Royal Avenue in Baltimore and earned a chemistry degree at the College of William and Mary, where he was a member of Lambda Chi Alpha fraternity.