Monday, May 24, 2010

Bringing Prescription Drug Policing to the People

by Michael Spitz
Senior Digital Strategist, Ignite Health

Bringing Prescription Drug Policing to the People
What the New FDA “Bad Ad Program” Means To Pharma and Its Marketers

What Is It?

On May 11, 2010, the U.S. Food and Drug Administration (FDA) launched the “Truthful Prescription Drug Advertising and Promotion (“Bad Ad Program”) empowering healthcare providers with the ability to report drug promotion considered to be misleading directly to the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC). Categories of promotion include:

- Sales representative presentations

- Speaker program presentations

- TV and radio advertisements

- All written or printed prescription drug promotional materials

What Is the Call to Action?

Healthcare professionals are now encouraged to report a potential violation in drug promotion by sending an email to mailto:badad@fda.govor calling 877-RX-DDMAC. The agency enables anonymous submissions, but encourages inclusion of contact information for follow up. Violations to recognize and report include promotions that:

- Omit or downplay risk

- Overstate effectiveness

- Promote off-label, or unapproved, uses

- Contain misleading drug comparisons

What is the Rationale?

As described in the Dear Colleague Letter introducing the program, spending on advertising to healthcare professionals outpaces spending on DTC by nearly 3 to 1, and often takes the form of “detailing” which occurs primarily in places such as medical offices, hospitals, pharmacies, at medical meetings and symposia, and other meeting facilities. Although informative and responsible promotional efforts by pharmaceutical companies can provide healthcare professionals with valuable information about the latest drug therapies, the FDA is asking for help in their efforts to scrutinize these more private promotional channels.

How Will It Work?

Administered by the agency’s Center for Drug Evaluation and Research (CDER), the program will roll out in three phases, beginning with the engagement of healthcare providers at specifically-selected medical conventions and partnering with medical societies for the distribution of educational materials. The latter two phases will expand on these collaborative efforts and update these materials accordingly.

What the Program Means to the FDA

“The Bad Ad Program will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” said Thomas Abrams, director of DDMAC.

What the Program Means to Healthcare Providers

Democratization of the Internet through social media has empowered millions with the opportunity to share their opinions and communicate directly with one another through Web 2.0—a communications strategy expertly channeled by the Obama campaign and now his presidency, fostering such recent and potentially promising initiatives as the HHS Open Government Plan.

The “Bad Ad Program” seems an organic extension of that idea, “crowdsourcing” expert surveillance of drug promotion through the healthcare professional audience itself. Since many physicians have been early adopters of social media, embracing peer-to-peer discussions through platforms like SERMO and Medscape Physician Connect, active engagement and feedback should come naturally to them.

But how well and to what extent professionals comply is dependent on numerous variables, including success of the program’s education goals and their willingness to police promotional materials. Anonymous submissions would allay risk, but will additional incentives be required to encourage and sustain engagement? Only time will tell.

What the Program Means to Healthcare Marketers

Strict regulatory compliance with all public-domain promotional materials such as TV and radio advertisements and websites is a given in our industry. We also understand that more internal channels such as sales rep and speaker presentations must contain accurate data and sufficient fair balance, but these outlets have been far less scrutinized. Not anymore. Knowing that all healthcare professionals are now encouraged and empowered to recognize and report any potentially misleading drug promotion, it behooves us to take extra care and to ensure that all the materials we produce are compliant to the fullest extent of the law.

Meanwhile “Government 2.0” has clearly arrived, one where citizens become extensions of the agencies serving them. The good news is that this high degree of interactivity fosters transparency and freedom; the potential bad news is that it can also promulgate misinformation and confusion. Along the way we’re all going to have to get used to a world where individual consumers have unprecedented influence over our brands and how we promote them, compelling us to stay true to the mission we as healthcare marketers must share with DDMAC:

- Protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicates

- Guard against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs

What Does the Program Mean to YOU?

Share your thoughts regarding the FDA’s new “Bad Ad Program” below. We’d like to hear from you!

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