Thursday, April 17, 2014

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In its opening remarks in comments submitted to the FDA regarding recent Draft Guidance ("Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal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BIO mimics many of PhRMA's criticisms such as calling on the FDA to align the Draft Guidance more closely to the law; i.e., Federal Food, Drug and Cosmetic Act (FFDCA).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.

Delete This and Delete That, Says Novartis to FDA Regarding Recent Social Media Guidance

The comments are in! As usual, the pharma industry waited until the last second to submit comments to FDA Docket 2013-N-1430 regarding "Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" (see "FDA Publishes First Piece of Long-Awaited Social Media Guidance").

See the end of this post for links to all the comments submitted. In this and following posts, I review a few of the comments made by major players (Novartis, Pfizer, PhRMA, and BIO).

I have already interviewed a few other people about the comments they submitted. Listen, for example, to this podcast: "The Clouds of Social Media Guidance" and this Pharmaguy Audio Snippet from Paul Ivans, President and CEO, Evolution Road, LLC:



In my opinion, the most "cheeky" comments come from Novartis, which advised FDA to "delete" some specific wording from  the guidance and example 3, which has to do with pharma marketers making suggestions for placement of its promotional messages on independent third-party sites. Novartis suggests that FDA delete the phrase “but does not direct the placement of the promotion within the site” and delete completely example 3.

Cheeky or not, Novartis is very elegant and precise in explaining the rationale for its suggested edits.

Tuesday, April 15, 2014

Total Prescriptions Written & Per Capita Spending in U.S. Rise in 2013

According to a new report issued today by the IMS Institute for Healthcare Informatics, total spending on U.S. medicines increased 1.0 percent on a real per capita basis in 2013, while the use of healthcare services overall rose for the first time in three years.

The study – Medicine Use and Shifting Costs of Healthcare: A Review of the Use of Medicines in the United States in 2013 – found that "total dollars spent on medications in the U.S. reached $329.2 billion last year, up 3.2 percent on a nominal basis and a rebound from the 1.0 percent decline in 2012. Primary drivers include the reduced impact of patent expiries, price increases, higher spending on innovative new medicines, and greater use by patients of the healthcare system."

Over one-third of this spending was concentrated in 5 therapeutic areas: Oncology, Antidiabetes, Mental Health, Respiratory, and Pain. Three specialty classes (MS, autoimmune, and oncology) contributed $6.9Bn, or 68% of total growth. See the following chart:

Saturday, April 12, 2014

Mickelson's PGA Standing vs. Enbrel's DTC Spending

Phil Mickelson, 5-over, missed the cut at the Masters this year. Bummer!

Because of that, you might not see more Enbrel ads featuring Mickelson who is a hired gun - er, celebrity spokesperson - for the Enbrel brand (see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign"). Unless, of course, the TV ads were pre-purchased at a discount to run during the Masters.

It makes sense for Amgen to cut back on running the Mickelson-Enbrel ads if Phil is not going to be in the Masters. But Amgen already cut back on Enbrel advertising in 2013. That year, the Enbrel DTC spend was $77 million (see here) according to Nielsen. In comparison, the spend was $127 million in 2012 (see here).

Why did Amgen but back on Enbrel DTC in 2013 when Mickelson was doing well at the Masters and had a decent PGA standing?

Just for fun, I did some research to compare Mickelson's PGA standing and Enbrel's DTC ad spend from 2010, when Mickelson was first hired as an Enbrel spokesperson, to 2013, the latest year for which figures are available.

Here's what I found.