FDA to determine if toll-free phone number is needed in drug advertisements
WASHINGTON The Food and Drug Administration might require drug advertisements to include a toll-free number that patients can call to report side effects.
The agency is interviewing 1,600 consumers to decide whether to make TV commercials to carry the number. It already requires print ads for drugs to include FDA contact information. The consumers will be shown a fictitious drug commercial and asked how much information they understand.
The FDA said it needs to determine whether including the phone number would made drug advertisements too complex. It already requires commercials to list drugs’ potential side effects, which often makes them significantly longer than commercials for other products.
NOCA recognizes PTCB’s Corrigan with Certification Industry Leadership Award
WASHINGTON Melissa Murer Corrigan, executive director and chief executive officer of the Pharmacy Technician Certification Board, has received the 2008 Certification Industry Leadership Award from the National Organization for Competency Assurance, PTCB announced Tuesday.
PTCB said the award recognized Murer Corrigan’s leadership in the field of certification and licensure. She has certified more than 320,000 pharmacy technicians as the founding executive of PTCB.
“This award is a tribute to the hard work and dedication of all my colleagues and partners involved in making PTCB a success since our founding in 1995,” Murer Corrigan said in a statement. “The certification of pharmacy technicians in the U.S. has advanced the patient safety of millions of Americans, and I am so proud of the PTCB team and all of our certified technicians.”
FDA warns Shionogi to end unsupported Cedax claims
ROCKVILLE, Md. The Food and Drug Administration released a warning letter to Shionogi and Co. Tuesday regarding its antibiotic Cedax.
The FDA said the company made inflated claims about Cedax (ceftibuten) and downplayed the health risks associated with it. Promotional materials sent to doctors claimed the drug had “excellent tolerability,” even though data did not support the claim.
The drug is approved for treating mild to moderate bacterial infections.