美女免费一级视频在线观看

Pharma marketers are about to develop tremendous leg strength thanks to the defensive crouch the Food and Drug Administration has forced them into. 

By issuing a broadside of 40 Untitled Letters to various pharma and life science companies on September 9, the agency is calling out many of the practices that have become pharma marketing tropes: a couple dancing as a smiling band performs while a voiceover intones the risk statement, for example.

In the near-term, the FDA is forcing medical marketers to rethink every facet of campaigns and making campaign planning even more of a headache than it usually is.

While most marketers and leaders in this space are taking a “steady as she goes, no need to worry” approach outwardly, behind closed doors there is a fair amount of panic caused by the increased scrutiny and the uncertainty it brings along. 

One agency head who asked to remain unnamed because they weren’t at liberty to speak for a client said, “It is full-on panic mode back at HQ. Chaos ensues.”

So what’s a beleaguered pharma marketer to do? Do your job. Help your clients sell the products and services they still need to bring to market.

Here’s MM+M’s best advice for pharma marketers, based on what we read in the 40 letters.

1. Remember: There is no pharma ad ban

Don’t panic, because nobody has tried to ban pharma marketing. Yet. 

“I run the FDA. Pharma Ads Are Hurting Americans” blared the digital headline over an op-ed by FDA Commissioner Marty Makary, MD in Tuesday’s edition of The New York Times. 

It doesn’t mean ads have been banned. It does mean there is increased scrutiny of both paid advertising and influencer marketing of pharmaceuticals. 

In some cases, this is to the point of knit-picking, like there being too many scene changes in the Jardiance commercial Musical: Movie Night, for example.

Still, there are also some legitimate beefs, which may feel undue given that the FDA hadn’t issued an Untitled Letter to drugmakers in eight years. 

Be prepared to play strictly by the letter of the law and remember what your end goal is. 

“The FDA’s actions are a good reminder that science is ultimately about people, and how we communicate it can build trust or create confusion,” says Calcium’s group president and managing partner Greg Lewis. “There’s an opportunity here to build trust by being even clearer in our communications.”

2. Bend over backwards to present fair balance. 

The most consistent complaint in the 40 letters is a failure to present a fair balance between the benefits and risks of the product. 

Fair balance can be construed in many ways, including distracting images and varying type faces and weights. So, to be clear: don’t distract — or delight — with visuals while risks are being mentioned in an audio track. 

Pfizer’s ad for ulcerative colitis drug Velsipity was cited for the use of a distracting creature that represented the condition and whose on-camera hijinks were deemed a distraction to the risk statement voiceover.

As for digital ads, don’t bury risks in scroll boxes. In print or PDF materials, give benefits and risks equal type sizes and weights. 

If the product addresses a specific population, make sure you present the risks inherent specifically to that population. And don’t omit anything, especially on social media, even when the format is constrained.

3. Substantiate everything 

This is a big one: don’t make any claims about how well a drug works unless you have proof from a clinical trial. 

The ad for Bausch’s toenail fungus treatment Jublia was cited for presenting misleading claims about results that were inconsistent with the results of a clinical trial. 

Don’t overstate efficacy or claim that a drug works better than a competitor unless you have proof from a head-to-head clinical trial — and say so in the ad. 

Also, stay far away from off-label uses — talk only about what the drug is FDA-approved for, even if the off-label use is common practice.

4. Be hyper-vigiliant with digital promotions, social media

The letters make it clear that the FDA sees nothing but blurred lines in the digital and social landscape. Help define the lines for them. 

If you’re working with an influencer or celebrity, they need to say they’re being compensated, and they need to say it loud and clear. You also need to take responsibility for user-generated content (UGC) that could make claims about your product. 

While it remains unclear what effect this could have on patient community forums, you need to control what you can control, so you may need to reconsider ad adjacencies for your products in such forums. 

5. Review all of your processes

This is good advice in any environment, but especially now. 

Timmy Garde, chief growth officer of Ardelis Health, suggests an immediate audit of all existing campaigns as well as a thorough review of medical, legal and regulatory (MLR) procedures. 

“I’d also train internal teams on the changing regulatory environment,” says Garde, who, ever the optimist, sees an opportunity in the chaos. “Leverage your relationships with HCPs to make sure they’re well-informed so they can educate patients on their disease states and provide appropriate therapeutic therapies.”

6. Ready for what a potentially radical change to TV ads 

The FDA is coming after “adequate provision.” 

If that child sliding down a rope is too distracting for the American public, forget your idea for the chain saw-juggling clown troupe and get ready to test your creativity on what to show on-screen while the risks and side effects are read in the voiceover.