Monday, April 21, 2014

Is FDA Seeing What We're Seeing with Its Old-School Web Browsers? Klick Health Wants to Know

In comments submitted to the FDA regarding recent social media guidance (read "FDA Publishes First Piece of Long-Awaited Social Media Guidance" for background), Klick Health -- an interactive agency that has pharma clients -- asked a lot of questions. One interesting question was "What browsers does the FDA use when reviewing social media sites such as Facebook?"

Actually, Klick said this:
"Since public social properties will be reported via links, we would like the FDA to publicize what browsers it uses when looking at these properties. Normally, this would not be an issue as the social properties tend to render well on all recent browsers but screen captures provided on the NOV letter regarding Tirosint cast doubt on what the FDA may be seeing when it reviews social properties."
Klick Health believes FDA may be using out-of-date browsers that make it tough to know whether a Facebook page -- such as the Tirosint page in question -- was in development or whether it had "actual content" when the FDA looked at it.

As evidence, Klick Health referred FDA to a screen capture of the page on its blog where it compared what the page looks like on a "modern" browser (see below):

Friday, April 18, 2014

What Pharma Can Learn from the CPG Industry About Social Media: If You "Like" Me, You Can't Sue Me!

The social networking savvy of consumer packaged goods (CPG) industry is often cited by pharma marketing consultants as something the pharmaceutical industry should emulate.

Here's what one interactive agency -- picked at random via a Google search -- suggested its pharma clients should expect from their digital agency:
"They should also know industries like consumer packaged goods (CPG) or consumer electronics or any other industry where some of the newest digital strategies and tactics are being tried. This will allow them to reapply these lessons to healthcare/pharma. If your agency only knows healthcare/pharma, then you’re missing something and probably doing the same thing as last year" - (copied from this post).
That's all very well and good as far as "digital strategy" per se goes, but pharma companies may also learn from CPG companies how to modify their Terms of Use agreements on their digital and social media sites (even Facebook?) to prevent users from suing them. Not that that's a good thing!

As reported in the New York Times (here), "General Mills, the food mega-corporation that owns Betty Crocker, Nature Valley, and Cheerios, has "quietly added language to its website to alert consumers that they give up their right to sue the company if they download coupons, 'join' it in online communities like Facebook, enter a company-sponsored sweepstakes or contest or interact with it in a variety of other ways."

I know of at least once instance when this policy, known as "forced arbitration," could have helped a major pharma company.

Thursday, April 17, 2014

Digital Health Coalition Urges FDA to Launch a Social Media "Laboratory" to Ensure Adequate Guidance Progress

In comments submitted to the FDA regarding recent social media guidance (read "FDA Publishes First Piece of Long-Awaited Social Media Guidance" for background), the Digital Health Coalition (DHC) -- comprised mostly of pharma companies and digital agencies -- suggested that the FDA establish a “lab” to "help ensure the guidance progresses in a manner and at a rate to be informative and protective for all parties involved."

"One critical point of any guidance is applicability in the real world," said DHC. "It will be helpful for the DHC and its members, for the FDA to take as many practical and real examples of current social media tools and environments and run simulations on what this guidance could mean in each case [my emphasis]."

"To complicate things, there are innovations and new platforms coming out all the time and one could never be exhaustive about it without being dated months later, but such a detailed and joint exercise with industry and agency experts would be highly informative and would reveal the practical realities of this evolving guidance."

"Realizing we do not live in a world of black and white," noted DHC, "we do need additional and more concrete real-­world examples of what 'limited scope' with regard to 'influence' means in practical terms to further foster innovation of interactive patient communication."

The DHC said it is willing to "partner with the FDA to identify such concrete examples and perhaps create mock-­ups in a laboratory environment for further analysis and discussion." I guess this is a pitch for an RFP from DHC.

What would such a "laboratory" look like?

BIO Mimics PhRMA's Comments to FDA Regarding Recent SM Guidance But Is More Polite About It

In its opening remarks in comments submitted to the FDA regarding recent Draft Guidance ("Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics"), the Biotechnology Industry Organization (BIO) thanks the agency for acknowledging the "unique characteristics and logistical considerations presented by content available through the internet and social media... Because of the uniqueness and rapid evolution of this media," said BIO, "it is important to apply flexibility in the regulatory approach to enable companies to participate more fully and develop responsible policies and practices to help advance and encourage the safe use of their products."

PhRMA, on the other hand dives right into criticism of the agency (read "PhRMA Questions Legality of FDA's Recent Social Media Guidance") and only thanks the FDA for its efforts, lousy though they may be, in its closing paragraph!

BIO mimics many of PhRMA's criticisms such as calling on the FDA to align the Draft Guidance more closely to the law; i.e., Federal Food, Drug and Cosmetic Act (FFDCA).

"As a predicate matter," said BIO, "when FDA considers the final guidance and future guidances, the Agency should clarify that the appropriate definition of 'labeling' is found in 21 U.S.C. §21(m), the general regulatory definition of labeling in 21 C.F.R. 1.3(a), and relevant case law" (including Kordel vs. United States; see here).

So, like PhRMA, BIO is taking FDA to school about regulatory law. BIO, however, couches its criticism as a debate ("predicate matter") whereas PhRMA invokes legal consequences: "a significant chill on First-Amendment-protected speech."

Wednesday, April 16, 2014

More Free Rx Drug Samples, More Branded Drug Prescriptions. Duh!

According to a study published today in JAMA Dermatology, branded and branded generic drugs (products that have novel dosage forms of off-patent products or use a trade name for a molecule that is off patent) accounted for 79 percent of the prescriptions written nationally by dermatologists compared with 17 percent at an academic medical center without samples. The average total retail cost of prescriptions at an office visit for acne was estimated to be twice as high ($465) nationally compared with about $200 at an academic medical center without samples.


In a related editorial, Kenneth A. Katz, M.D., M.Sc., of the Permanente Medical Group Inc., Pleasanton, Calif., and colleagues write: "...the demonstrated association between samples and prescribing is strong and is consistent with a growing body of evidence that drug samples affect physician prescribing practices."

It's interesting that while the percentage of prescriptions written with samples has decreased over time for other specialists, prescriptions with samples written by dermatologists have increased!

Here's the chart:

PhRMA Questions Legality of FDA's Recent Social Media Guidance

The FDA received about 20 comments from representatives of the pharmaceutical industry, In my last post, I summarized the comments submitted by Novartis (see "Delete This and Delete That, Says Novartis to FDA Regarding Recent Social Media Guidance").

In this post, I summarize some of the comments submitted by the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country‘s leading pharmaceutical research and biotechnology companies.

Novartis may be "cheeky" in suggesting that the FDA delete this and delete that, but PhRMA takes a decidedly litigious stance and suggests that the FDA is overstepping its authority under the Federal Food, Drug and Cosmetic Act (FDCA) and the First Amendment.

 Instead of asking the FDA to clarify what it means by drug firms having "influence" over third-party sites -- which is what most other commenters asked -- PhRMA said that holding a biopharmaceutical manufacturer accountable for content written by third-parties on third-party web sites if the company merely "influences" the third-party is
"overbroad and is inconsistent with the FDCA. Put simply," said PhRMA, "third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance."
And that's the end of that! But PhRMA had plenty more to say about the Draft Guidance.