More New Guidance from FDA: Brand and Generic Name Treatment

Introduction
On January 24 FDA issued new, final guidance on “product name placement, size, and prominence in advertising and promotional labeling.” I can tell you up front this still isn't the long-awaited social media guidance. Instead, the document sets out to clarify FDA requirements and expectations for how and when brand names and generic names should appear in promotional advertising.

Channels/Media Addressed
The guidance applies to all channels and it specifically calls out traditional print, audio-visual, broadcast, and “electronic and computer-based” ads and “Internet promotion” such as “social media, e-mails, CD-ROMs, and DVDs.”

Types of Products to Which this Applies

• It applies to prescription human drugs, including biologicals, and prescription animal drugs.
• It also clarifies direction based on if the product is made up of one active ingredient [example: PRODUCT (generic ingredient)] or more than one active ingredient [example:   PRODUCT (ingredient 1 and ingredient 2)].

Issues Addressed
Overall the document addresses the juxtaposition and treatment of how the generic name (“established” ) name should appear in relation to the brand (“proprietary”) name, including:

• placement
• size
• prominence
• frequency

Implications
We will be digging into it and providing more analysis soon .... Is it a big "no new news here," or is it a "holy crap, it's time to review all our promo materials pronto!"?

Meantime, if you plan on reading it, here's a helpful translation for key terms from FDA-speak to marketing-speak:

• Proprietary = brand name
• Established = generic name
• Running text = main body copy “the body of text in a piece as distinct from headlines, taglines, logos, footnotes, graphs, or pictures”

Stay tuned!http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070076.pdf

Piracy, Privacy, and 12 Months of Weigh-Ins Going Public

It's been an interesting week in the world of Internet news. Websites such as Wikipedia protested proposed anti-piracy bills SOPA and PIPA, and they won. This morning it was announced that the FBI shut down one of the world's most popular file-sharing sites, Megaupload. Then hackers "Anonymous" promptly retaliated with an attack on Justice Department public websites. Quite a week for Internet drama! Apparently piracy is the new black.

This week I had some personal drama regarding another internet-related concern that starts with P:  Privacy.

About a year ago I purchased a household gadget that merged technology and health: a Withings WiFi bathroom scale. I've been diligently weighing in (almost) daily and building up a database of the losses(and - over the holidays - gains) of my weight and BMI. The nifty scale automatically uploads my numbers to the website, and I can look at the charts and graphs online whenever I like. (For the record, I love it!)

But when I tried to log into my account this week, I was unsuccessful. My password worked intermittently, and when it did work, I still couldn't get to my dashboard of data. Then I noticed a small message on the login page that Withings was experiencing "a vicious attack" on their servers. They hoped that service would get back to normal very soon.

Hackers! Trying to get to the year-long history of my weight gains and losses and BMI! Whaaaaaaaaaaat?

Horrors!!!!

Sure, hackers have stolen my credit card information and bought airline tickets to Arabian countries. That little thing has all been taken care of. My bank sends me a new check card fairly regularly with a note that a database somewhere was hacked. No problem. Sure, I have a lot of personal information about myself "out there" online - probably more than most. I realize there is a certain amount of risk in submitting information on the Internet.

But a log of the past year of the ups and downs of my personal weight and BMI going public? That's a whole new level of problem.

Okay, yes, I'm being overly dramatic and there's no proof any data was actually stolen. But the concept of my weight data being stolen, held for ransom, being published online, or used for blackmail have all crossed my mind more than once this week.

I don't know much about the progress of electronic medical records. I know it's a huge task and I know its going slow. I understand the incredible benefits that having all of ones' health information in one place could bring.  But this weeks' drama has also had me thinking a little more carefully about if I would want all my information "out there," in records that were supposedly private, with the chance of going public thanks to hackers and attackers.

Makes me a teensy bit nervous. Just sayin'.

How do you define DTC?

This topic comes up a lot around my agency: How do you define DTC?

Of course, on the surface, DTC in the context of pharma marketing stands for "direct-to-consumer." Its roots likely go back to when FDA first appoved the marketing of prescription products to U.S.consumers in the 1980's.

John Mack's Pharma Marketing Glossary defines DTC as "The promotion of prescription drugs by pharmaceutical companies directly to consumers via broadcast and print media such as television, radio, magazines, billboards, and also the Internet." And according to a number of articles on the FDA website, FDA defines it as:

"Provided by drug companies, these ads are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio, and published in magazines and newspapers. They also appear online."

But still, I hear many, many marketers make "DTC" synonymous with "T.V." And I think that's an insult to all of the many other options for reaching consumers with information - and yes promotion - about pharmaceutical products.

Making DTC synonymous with TV assumes:

• Other channels aren't direct
• Other channels don't reach consumers
• Other channels don't matter
• FDA doesn't care about other channels

Of course, none of the above are true.

TV can certainly be an effective way to reach mass audiences for the right product and disease category. But in this day and age, other channels matter. And other channels reach consumers. Often, other channels are more efficient options.

DTC. It's one of many acronyms for which this industry is (in)famous. What does it mean to you?