US Doctors Urged To Report Misleading Drug Promotions
American health officials are encouraging doctors to report misleading promotions from pharmaceutical salespeople pitching medicines in doctors’ offices or over a business dinner.
The effort aims to increase regulators’ reach into the biggest area of prescription drug promotion i. e. private contacts between drug company salespeople and prescribers.
The law requires prescription drug marketing to be truthful and balanced. However, the US Food and Drug Administration (FDA) staff routinely check advertisements on television or in magazines and medical journals, finding it hard to track closed-door sales tactics like a chat inside a doctor’s office or a sales presentation over a meal.
FDA staff will begin setting up booths at major medical conferences starting this month, telling doctors how to spot questionable pitches. As well, the agency also proposes sending a letter to around 33,000 healthcare providers about the campaign, dubbed the Bad Ad Programme, asking doctors to report questionable activities to the agency.
The idea comes from two former drug company pitchmen now working in the FDA office.
Drug companies make major investments in promoting drugs directly to doctors, in a practice called detailing, spending three times more i. e. $12 billion on detailing.
For years, physicians have been able to report adverse drug events to FDA via a programme called MedWatch. Now, they can also report misleading or inaccurate promotions of prescription drugs to the agency,
Common FDA violations include:
· Omitting or downplaying a drug’s risks.
· Overstating a drug's effectiveness.
· Promoting off-label or unapproved uses.
· Making misleading drug comparisons.
Physicians can report such infractions to the Division of Drug Marketing, Advertising, and Communications in the FDA’s Centre for Drug Evaluation and Research by sending an email to BadAd@fda.gov, calling 877-793-3622 or writing a letter to FDA/CDER/DDMAC, 5901-B Ammendale Road, Beltsville, Maryland, 20705-1266.
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