FDA to hold hearing on creation of behind-the-counter drug classification
ROCKVILLE, Md. The Food and Drug Administration in Thursday’s Federal Register announced a public meeting to obtain comments regarding the creation of a third-class of drugs, or behind-the-counter drugs.
The FDA is currently fielding public comment as it explores the public health benefit of certain drugs being “available without a prescription but only after intervention by a pharmacist.”
The public meeting will be held Nov. 14 from 8 a.m. to 5 p.m. at the National Transportation Safety Board Conference Center in Washington.
Historically, the Consumer Healthcare Products Association, which represents manufacturers of nonprescription medicines, has stood against any third class of drugs. The American Pharmacists Association has in the past proposed a “pharmacy-only” classification of drugs and the National Association of Chain Drug Stores has in the past declined to take a position one way or the other without a clearer understanding of any proposed BTC system impacts on the industry, including reimbursement issues and time commitments on behalf of the pharmacist.
FDA commissioner Andrew von Eschenbach first brokered the third-class-of-drugs topic earlier this year at the CHPA annual meeting.
New prescription allergy treatment Xyzal now available for fall allergy season in the U.S.
PARIS UCB and Sanofi-Aventis’ new once-daily medication used to treat indoor and outdoor allergies, is now available by prescription in the United States, the companies said Tuesday.
Xyzal is an oral antihistamine that has been shown to provide powerful allergy symptom relief, and is approved for use in adults and children 6 years and older.
“Allergy patients need a prescription treatment option that works quickly to relieve their suffering,” said Michael Blaiss, clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. “It is important for people living with allergies to work with their physician to develop an appropriate allergy treatment plan that will effectively reduce their symptoms.”
The Food and Drug Administration approved Xyzal in May. Last year, UCB and Sanofi-Aventis entered into an agreement to launch and co market Xyzal in the United States.
Xyzal is currently marketed in more than 80 countries worldwide, including the European Union. The FDA approval is based primarily upon the results of eight randomized, placebo-controlled clinical trials involving over 2,000 patients.
President Bush Vetoes SCHIP
LANCASTER, Pa. President Bush vetoed a bill Wednesday that would have renewed and further developed the state-federal health insurance program for children in low-income families.
The program, known as the State Children’s Health Insurance Program, or SCHIP, was vetoed Wednesday morning as the president affirmed that the program expansion would be too costly. Bush said it was reaching limits beyond its original objective.
The president said that several states are spending more money on adults than children. He also declared that the proposal could have possibly allowed children in families earning as much as $83,000 a year to receive coverage under the program, which diverts them away from private health insurance.
“That doesn’t sound poor to me,” Bush said. “The policies of the government ought to be: help poor children and to focus on poor children. And the policies of the government ought to be: help people find private insurance, not federal coverage. And that’s where the philosophical divide comes in.”
Bush added that the bill passed by Congress manifests “the desire by some in Washington, D.C. to federalize health care. I don’t think that is good for the country.” He said the government should be doing more to make private insurance affordable to those who lack health coverage.
“I don’t want the federal government making decisions for doctors and customers,” he added.
Congress had been working to draft the revision of the 10-year-old program, which expired September 30. The veto, however, does not mean the program will end immediately. Bush and Congress have agreed to extend the current program though November 16 while they try to work on a new version. Some political figures, however, said that it is not enough.
“Today we learned that the same president who is willing to throw away a half-trillion dollars in Iraq is unwilling to spend a small fraction of that amount to bring health care to American children,” said Sen. Edward Kennedy, D-Mass. “The Congress has done its job, passing a bipartisan bill that meets a critical need without adding a penny to the federal deficit. The president has broken his promise to America’s children.”
If it had been approved, the monies given to the program would have stemmed from an increased tobacco tax.