Wednesday, April 16, 2014

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 Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment.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 But PhRMA had plenty more to say about the Draft Guidance.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.

Friday, April 11, 2014

The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital

April is the nicest month -- for data about direct-to-consumer (DTC) ad spending for the previous year thanks to MM&M magazine, which published Nielsen data in this month's issue. I've summarized the data in a couple of charts as I have done in previous years.

Keep in mind that the absolute numbers refer only to "measured" media (broadcast, print, outdoors, and B2B) and, in this case, does NOT include digital ad spending (more on that later). The numbers also do not take into account discounts -- they reflect "list" pricing as it were. At least that's my understanding.

The important take aways are the trends and comparisons between companies and brands AND estimating how much is spent on digital versus traditional media. More about that later in this post.

First up - the TOP 20 Big DTC spenders (i.e., companies) for 2013.

Click for an enlarged view.
The spending by the top 20 companies represents adds up to about $3.6 billion or 95% of the entire 2013 DTC spend, which was $3.8 billion (including Internet display ad spend). In 2011, the top 20 accounted for about 90% of the total DTC spend.

The takeaway?

Wednesday, April 09, 2014

An FDA Approved Opioid Delivery System

The Food and Drug Administration (FDA) announced the establishment of a docket (here) to receive suggestions, recommendations, and comments on innovative packaging, storage, and disposal systems, technologies or designs (“designs”) that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others.

Comments submitted in response to this notice will help the Agency determine whether innovative designs for opioid analgesic packaging, storage, and/or disposal systems could help prevent or deter misuse and abuse without diminishing access for patients with legitimate prescriptions.

These systems may include functionality to remind patients to take a dose, track when a dose is taken and how much is taken, and limit further access until it is time for the next dose. Additionally, many of these drug-device combinations electronically encrypt and capture the accumulated adherence data, which can be downloaded directly from the device or wirelessly transmitted to the prescriber.

I respectfully submit the following design …