'

DrugWonks on Twitter

DrugWonks on Facebook

CMPI Videos


Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts


Indiana Governor Mitch Daniels


Montel Williams, Emmy Award-Winning Talk Show Host


Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine


CMPI president Peter J. Pitts


CMPI Web Video: "Science or Celebrity"

Social Networks



Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS




Add This Blog to my Technorati Favorites
Political Blogs - BlogCatalog Blog Directory

Tabloid Medicine

Please Check out the latest book by
Dr. Robert Goldberg Ph.D.
"Tabloid Medicine"

Check Out CMPI's Book

Physician Disempowerment:
A Transatlantic Malaise

Edited By: Peter J. Pitts
Download the E-Book Version
Here

CMPI Events

Donate

CMPI Reports

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP

Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum

Club For Growth
CNEhealth.org

Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare

Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst

The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
 


Bad Ad Program a Waste of FDA Time and Resources

2017-01-23 | Peter Pitts
From the pages of Inside Health Policy ...

Some Health Policy Experts Question FDA's New Deceptive Ad Studies

A former FDA associate commissioner and a free-speech advocate question two proposed agency studies to determine the extent to which health care professionals (HCPs) and consumers can detect and report deceptive prescription drug promotion. The experts also raise concerns about the agency's plan to create a program for consumers to directly report deceptive advertising to the agency. However, another former FDA official saw the announcement as par for the course for the agency's drug promotion office's growing research program.

FDA announced Jan. 4 its intention to conduct two studies to determine the ability of HCPs and consumers to identify deceptive advertising.

"Prescription drug promotion sometimes includes false or misleading (i.e., deceptive) claims, images, or other presentations; for instance, representations that a drug is more effective or less risky than is demonstrated by appropriate evidence. A number of empirical studies have examined the occurrence and influence of deceptive promotion, both in regard to prescription drugs…and other products...No research to our knowledge, however, has investigated the ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion," FDA wrote in the Jan. 4 agency notice.

The proposed project involves two studies, both of which will entail subjects viewing websites promoting fictitious drugs.

Study one will examine how the level of deception in promotion affects subjects' perceptions and behavior. The level of deception will be varied over three levels, which the agency defines as: none, fewer, and more.

The study will attempt to answer: the proportion of subjects that can identify a promotional piece as deceptive and whether the ability to identify deceptive promotion varies depending on the level of deception; whether the degree of deception affects consumers' and HCPs' actions, including reporting the advertising; and whether people who recognize information as deceptive adjust their "attitudes and intentions toward the product."

Study two will compare the impact of implicit deceptive claims, which "suggests or implies an unstated piece of information," versus explicit deceptive claims, which "fully and clearly expresses information and leaves nothing to be implied," according to the agency notice.

Subjects in study two will be shown three websites: an explicitly false web site, a factually true but implicitly misleading site and a website with no misleading information. The study will explore whether the ability to identify deception varies depending on the type of deception; if the type of deception affects subjects' behavior, including reporting to authorities; and if detection of deception impacts a person's actions.

The agency argues that people's ability to detect deception affects public health.

"The ability to identify such promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe. In the case that consumers and HCPs are able to identify deceptive promotion, then they may instead be equipped to incorporate such information into their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action," the agency writes.

However, Peter Pitts, president of the Center for Medicine in the Public Interest and former FDA associate commissioner, questioned the usefulness of the planned studies. "I don't think the OPDP studies will make a difference to anything whatsoever," Pitts told IHP.

Pitts also told IHP he doesn't see the value in FDA studying fake ads, because actual ads already are reviewed by FDA. The agency's resources would be better spent looking at the impact direct-to-consumer ads play in patient and physician education, argued Pitts.

The former FDA official also maintained that FDA should be looking at marketing of dietary supplements, which he argued often cross the line into drug claims. "That needs to be slammed shut," Pitts told IHP.

Richard Samp, chief council at the Washington Legal Foundation, argued the new studies likely don't signal FDA will step up its enforcement of off-label communication. It's likely that FDA is instead trying to provide clearer guidance for companies to be in compliance with FDA regulations, Samp argued.

Samp, who recently urged "FDA to abandon its current, overly restrictive view of what constitutes truthful speech and to limit its speech-suppression efforts to speech that is truly false or misleading," told IHP that he applauds FDA for doing the studies. Samp maintained that the agency has recently been "[asking] a lot of very good questions."

Heather Bauelos, counsel at King & Spalding and a former associate chief counsel in the FDA's Office of the Chief Counsel, argued that the studies aligned with OPDP's ongoing research efforts.

"FDA's research on identifying deceptive drug promotion could potentially be related to these ongoing efforts, but strikes us as par for the course for OPDP. OPDP has a very active research program, which has been a growing area in recent years. The announcement and focus of this new study appears to fit neatly among other research priorities, particularly since the ability of consumers and HCPs to identify deceptive promotion is an area that OPDP has yet to investigate," Bauelos wrote to IHP.

When asked by IHP if the studies may impact FDA's regulation of off-label promotion, Bauelos argued that any enforcement activities that come out of the study would instead likely deal with issues such as risk minimization or unsubstantiated claims.

"Any use of the results of this research in enforcement activities would likely be related to misleading promotion and advertising, which might encompass off-label communications, but typically extend to issues of risk minimization, overstatements of efficacy and other unsubstantiated claims. Overall, the study results may likely provide more information about whether FDA oversight of prescription drug promotion and advertising is protecting the public health and related government interests," Bauelos wrote.

FDA also raised the possibility Jan. 4 of creating a deceptive advertising reporting program for consumers, similar to the "Bad Ad" program currently created for HCPs

"The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion…a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA. Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to monitor everything," the agency wrote.

Samp questioned whether a similar program for consumers would be worthwhile. "I suspect [consumers] are not in a position to identify so called bad ads," Samp told IHP. Samp also maintained that nothing currently prevents a consumer from contacting FDA if they feel they've been deceived.
Pitts called the original bad ad program "a complete waste of time," maintaining that FDA never really determined what was a bad ad, and that FDA should instead be focusing on regulating safety and efficacy. "FDA does not regulate creativity," Pitts added.