Alcobra plunges after FDA places hold on ADHD drug
Alcobra Ltd's market value more than halved on Thursday, a day after the company said the U.S. Food and Drug Administration had placed a hold on its lead experimental drug.
WASHINGTON The Food and Drug Administration believes antibiotics should be used on livestock only to cure or prevent disease and not to promote growth, a common use, said a high-ranking FDA official on Monday.
Principal deputy FDA commissioner Joshua Sharfstein said restrictions on livestock use would reduce the opportunity for bacteria to develop resistance to drugs used by humans.
Critics of the heavy antibiotic use in livestock, such as the Union of Concerned Scientists, estimate 70 percent of all antibiotics sold in the United States are used on food animals, mostly in tiny doses that promote weight gain or more efficient feed consumption.
Other groups say livestock's share of antibiotic use is much lower and the bulk of it goes to fighting or preventing disease.
"Purposes other than for the advancement of animal or human health should not be considered judicious use" and not allowed, Sharfstein said in a statement for a House hearing. "Eliminating these uses will not compromise the safety of food.
"FDA also believes that the use of medications for prevention and control should be under the supervision of a veterinarian," he said. This would mean no over-the-counter sales of antibiotics to farmers and ranchers.
Sharfstein told reporters afterward that his testimony was a statement of FDA principles. He said there was no administration or FDA position on a bill that would phase out nontherapeutic use in livestock of seven classes of antibiotics -- penicillins, tetracyclines, macrolides, lincosamides, streptogramins, aminoglycosides, sulfonamides -- and any other drug used to treat bacterial illness in people.
Identical phase-out bills were filed in the House and Senate on March 17 but have languished. The hearing on Monday by the House Rules Committee was the first in either chamber.
The FDA says 2 million Americans acquire bacterial infections during their hospital stay every year and 70 percent of the infections are resistant to at least one antibiotic.
Last fall, the American Veterinary Medical Association said Denmark's voluntary ban on use of antibiotics for growth promotion "has not resulted in a significant reduction of antibiotic resistance in humans" while disease and death in hogs increased.
The Pew Environment Group said on Monday the Danish ban had little or no effect on farm productivity and there was a decrease in antibiotic resistance.
(Reporting by Charles Abbott; Editing by David Gregorio)
A former Insys Therapeutics Inc district sales manager was arrested on Thursday on charges he participated in a scheme to pay kickbacks to doctors to prescribe a drug containing the opioid fentanyl, U.S. prosecutors said.
(Reuters Health) - Men exposed to dioxin, a chemical once common in herbicides, may be less likely to father boys than peers who didn’t come in contact with this toxin, a recent study suggests.