Rx on TV

Hey all,

Even though last week was my last day in the office, I want to post one last time and provide some closure on the internship. In my previous post, I promised a session on TV advertisements, and (because I hate breaking promises) you will find it somewhere in the blog post.

PRESCRIPTION DRUG TELEVISION ADVERTISEMENTS
Have you ever turned on the telly and accidentally ended up on Good Morning America or CNN (HA…“accidentally”)? If so, you may have noticed a commercial featuring a woman doing yoga and the drug, HUMIRA® [adalimumab].

Yup, I spent a good part of my internship discussing this commercial with the rheumatology team, and I will be available next week for autographs [/brag]. But seriously, the amount of work and compromise that goes into making one television commercial is mind-boggling. Not only that, but companies have to follow the FDA Drug Guidance on Consumer-Directed Broadcast Advertisements and the Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion.

I shall break those down into three easy payments*: Adequate Provision, Major Statement, and Other Nuggets. *Not all-inclusive of requirements

Adequate Provision
Along with the broadcast itself, the ad must make “adequate provision” for disseminating approved package labeling (read: drug information). There are no official right or wrong ways to ensure this provision, but companies typically (and should) provide the following four:

1. Toll-free number: provides drug information and an option to get labeling mailed to the patient
2. Referral to print material: “Please see our ad in blah blah magazine”
3. Referral to healthcare providers: “Ask your doctor or pharmacist for more information”
4. Website: "www.saynotodrugs.com"

For visual examples of the above, I randomly chose a Plavix television ad.

Toll-free number and referral to healthcare providers


Referral to Print Material


Website

Major Statement
As mentioned in my earlier posts, print advertisements include a printed Brief Summary of side effects, contraindications, and effectiveness. TV ads, on the other hand, present this information using what is known as a Major Statement—an audio or audio/visual alternative in layman’s terms to presenting risk information.

Example of Major Statement: “This drug is indicated for moderate to severe fractures of the clavicle. When taking this drug, you may experience side effects of nausea, vomiting, diarrhea, and loss of dignity. Don’t take this drug if you desire to play an integral role in society.”

Other Nuggets
The above two requirements cover a majority of the risk information, but there are other nuances that go into TV ads. I’ll just bullet them because they are easier to read.

• Superimposed text should be easy to read and contrast well with the background
• Superimposed text should be onscreen long enough to read and understand
• Background music should be comparable in volume and should not be distracting
• Avoid distracting graphics: busy scenes, frequent cuts, vivid visuals, moving camera angles

That’s about the gist of the TV ad requirements. As always, there are more regulations to cover, but I just wanted to go over the main topics. If you’re like me, watching these ads on TV will never be the same.

THE ABBOTT INTERNSHIP
This internship exceeded all expectations. I urge everyone thinking about a future in the pharmaceutical industry to apply and check it out. Even if you’re not interested in the industry, apply and check it out—you may be pleasantly surprised. There are a lot more pharmacists in the industry than you think, especially in medical information, medical review, and regulatory affairs. In these departments, you are surrounded by very intelligent people (shout out to my managers, fellow interns, and the regulatory affairs department) who put their medical background to use on a daily basis to, ultimately, ensure patient safety. Five stars: *****.

Eric Zhao

PS Be sure to check out my new posts at: On Rotation: Life as a Fourth-Year University of Michigan PharmD Student.

I am currently was a summer intern in the Regulatory Affairs Department, and the opinions and positions expressed are my own and don’t necessarily reflect those of Abbott Laboratories.