American Academy of Family Physicians

Printer-friendly version

Share this on AAFP Connection

Share this page

FDA Seeks Docs' Help in Cracking Down on Misleading Drug Promotions

New Program Will Teach Physicians How to Spot, Report Violations

By News Staff

The FDA announced this week that it is launching a program designed to educate health care professionals so that physicians and others can help the agency prevent the misleading or inaccurate promotion of prescription medications.
FDA News
The Division of Drug Marketing, Advertising, and Communications, or DDMAC, in the agency's Center for Drug Evaluation and Research intends to increase the effectiveness of its surveillance program, especially with regard to inappropriate activity by pharmaceutical sales representatives in physicians' offices and during presentations to health care professionals.

Thus, the agency's new Bad Ad Program aims to ensure that promotional information
  • is accurate,
  • balances the risks and benefits of a product,
  • is consistent with prescribing information approved by the FDA, and
  • includes only information that is supported by strong evidence from clinical studies.
The DDMAC plans to distribute educational materials through partnerships with professional medical organizations. Outreach efforts also will include exhibiting at medical conventions beginning this month.

"The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," said Thomas Abrams, R.Ph., M.B.A., director of the DDMAC, in a May 11 news release.

FDA Commissioner Margaret Hamburg, M.D., said in a letter to health care professionals (2-page PDF; About PDFs) that the pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on consumer-targeted advertising. Advertising aimed at health care professionals -- which occurs in places such as medical offices, hospitals, pharmacies and medical meetings -- often is beyond the scope of the DDMAC's surveillance efforts.

The DDMAC's monitoring of prescription drug promotion relies on review of industry materials submitted to the FDA, complaints filed by the pharmaceutical industry and field surveillance at large medical conventions, Hamburg said.

"While these efforts are effective, FDA's ability to monitor other promotional activities, which may occur in any number of settings, is limited," Hamburg said in her letter. "With the launch of the Bad Ad Program, FDA seeks to collaborate with health care professionals to address misleading promotion, wherever it may occur."

The FDA said examples of common violations include
  • omitting or downplaying the risks associated with a product;
  • overstating a product's effectiveness;
  • promoting off-label, or unapproved, uses of products; and
  • making misleading drug comparisons.
Physicians are encouraged to report potential violations related to drug promotion by e-mail or by calling (877) RX-DDMAC [79-33622]. Reports may be submitted anonymously, but the FDA encourages physicians to include contact information so that DDMAC officials can follow up, if necessary.

The FDA also has a campaign designed to educate consumers about misleading promotions.

Share this on AAFP Connection

Search AAFP News Now

 

Health of the Public

Though Waning, H7N9 Still Poses Pandemic Potential

AUA Says No to Routine PSA Screening

AAFP Criticizes Appeal of Plan B One-Step Ruling

AAFP to Hospitals: Stop Early Elective Deliveries

AAFP, USPSTF Differ Somewhat on HIV Screening Guidance

Zoledronic Acid Confers Both Pros, Cons

ACP Issues Guidance on PSA Screening

Abbott Recalls FreeStyle InsuLinx Blood Glucose Meter

Discuss Drug Options With Women at Risk for Breast Cancer

Shingles Vaccine Effective, But Uptake Is Low

Evidence Lacking to Make Oral Cancer Screening Recommendation

Two External Guidelines Get Qualified AAFP Endorsement

USPSTF Recommends BRCA Testing for High-risk Women

Primary Care, Public Health Look for Ways to Integrate

Malfunction Prompts Glucose Meter Recall

Evidence Lacking on PAD Screening, Says USPSTF

Azithromycin Poses Arrhythmia Risk, Says FDA

Vets With PTSD Often Prescribed Inappropriate Meds

AIM-HI Offers Grants to Combat Childhood Obesity

USPSTF Says No to Low-dose Vitamin D, Calcium to Prevent Fractures

PCV13, HibMenCY Vaccine Changes Approved by ACIP

AAFP, Other Groups Release More Choosing Wisely Lists

National Office Champions Tobacco Cessation Project Successful

USPSTF Issues Draft Statement on Glaucoma Screening

Study Examines Overuse, Inappropriate Use of Health Services

Apply to Become an AAFP Vaccine Science Fellow

Study Looks to Reduce PSA Screening Risks

AAP Issues New Clinical Guidance on Type 2 Diabetes

CDC: Adult Vaccination Rates Still Too Low

Pertussis Outbreaks Declining, but Immunization Still Key

2013 Immunization Schedules Include Several Changes

FDA Warns of Liver Injury Risk With Samsca Use

FDA Approves First Recombinant Trivalent Influenza Vaccine

AAFP, USPSTF: Screen Women of Childbearing Age for Partner Violence

Breast Cancer Screening in Older Women Costly, Likely Ineffective

CDC Gives Flu Update, Urges Continued Vaccination

Aerobic Exercise Beats Resistance Training for Weight Control