Wednesday, July 23, 2014

The "Risk-Only" Landing Page Requirement: Can We Get FDA to Adopt FTC's Thinking and Drop This Rule?

One of FDA's Ten Commandments -- the FIRST one, in fact -- states:
  1. You shall have no other regulatory agencies before Me.
Several people have asked me, "John, what other agency could pharma worship before FDA?"

Glad you asked.

The Federal Trade Commission (FTC) also regulates product advertising. The FDA, however, as per its first commandment, lords it over prescription (Rx) drug advertising, whereas the FTC regulates advertising of other health products, including supplements and over-the-counter (OTC) drugs. FDA, however, regulates what is claimed on the labels of OTC drugs.

Whatever. The main point is that FDA regulates advertising of Rx drugs and FTC regulates advertising of OTC drugs, most, if not all, of which began life as Rx drugs.

FDA and FTC regulatory guidelines are often very similar. In fact, when the FTC issued its guidelines for promotion via social media in March, 2013, I thought FDA's social media guidelines would be similar to FTC's.

No such luck!

The following table is a handy side-by-side comparison of the two approaches (FDA v. FTC).

Tuesday, July 22, 2014

Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access

According to the spring 2014 AccessMonitor™ report from global sales and marketing consulting firm ZS Associates, pharmaceutical access to physicians continues to decline. Only 51% of physicians/prescribers now allow access to sales reps, down from 55% in 2013 (see chart):

Source: ZS Associates

Even among traditionally pharma-friendly prescribers (e.g, dermatologists), access is down dramatically as illustrated in this chart:

Source: ZS Associates

The decline in access continues despite the downsizing of the pharma sales force by one-third since 2008. But, the downsizing has actually helped pharma deliver better sales calls.

How?

Why is PhRMA Defending Gilead's Sovaldi Pricing?

In an article published in The Hill, Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), whose job is to develop federal legislative, regulatory and political strategies, defended the pricing of Sovaldi, Gilead's Hep C drug (see "Defending Big Pharma").

Her argument was simply this: "While Sovaldi may cost $84,000 or more for an individual patient’s 12-week treatment, Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail."

Let's do the math on Sovaldi, using some numbers from the C. Everett Koop Institute, which may or may not receive funding from Gilead and/or PhRMA:

According to the Institute's data (see Hepatitis C: The Facts):
"The average lifetime cost for hepatitis C, in the absence of liver transplant, has been estimated to be about $100,000 for individual patients. Assuming that 80% of the 4.5 million Americans believed to be infected develop chronic liver disease, the total lifetime cost for this group (3.6 million) will be a staggering $360 billion in today's dollars. Assuming an estimated survival of 40 years, the annual health care costs for the affected U.S. population with chronic hepatitis C may be as high as $9 billion."
Saving $360 billion sounds like good news, right? But does the math add up to a savings for payers; e.g., Medicaid, Insurers, States, and patients?

Monday, July 21, 2014

FDA's Ten Commandments

Remember FDA's Social Media Webinar?

It was supposed to answer all our questions about the two recent social media guidances issued by the FDA.

There were technical difficulties and when participants could actually gain access and hear what was being said, they were surprised that the FDA presenters were simply reading the guidance documents verbatim.

"The #FDASM webinar, a haiku: Reading verbatim. Good use of my precious time? I'm not sure it is," tweeted @whendanieltalks.

This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the pharma industry will obey the current drafts of FDA's "ten commandments" remains to be seen. Personally, I think the industry wants to send Moses, er, Abrams, back up the mountain.

If FDA actually had ten commandments, these might be them:

Thursday, July 17, 2014

Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians?

Consultant and strategist Andrew Spong, PhD, former scholar and currently STweM‘s managing director, recently tweeted:

"Building trust is far from impossible for #pharma. Abstaining from digital conferences is a great start."

The tweet linked to a 2013 anti-pharma marketing screed posted on STweM titled "For pharma, the era of multi-channel marketing, closed loop marketing, sales force effectiveness, and market access is over"

I assume Spong singled out "digital conferences" because these buzzwords are frequently heard at such conferences.

It's a year later and the industry has "abstained" from using a couple of these buzzwords, at least within topics presented at industry conferences. "Multi-Channel Marketing" and "market access" are still frequently-used terms, but "sales force effectiveness" and "closed-loop marketing" are hardly to be heard nowadays at industry conferences.

Today, you will hear buzzwords like "Engagement" and "Centricity" as in "Patient Engagement" and "Patient Centricity."

So, it seems that pharma marketers have moved on and/or heard and obeyed Spong when he said:

"The era in which pharma could expect to be able to speak of ‘multi-channel marketing’, ‘closed loop marketing’, ‘sales force effectiveness’, or ‘market access’ without being called out as to their relevance, coherence, or appropriateness [with reference to the needs, interests, and concerns of the industry's patient, healthcare professional, and payer audiences] is over. As a consequence, pharma needs to get over them, too."

Now that pharma is using more customer-friendly terminology, is it any less "interested in its customers as bars on a chart, sales targets and data points than as people with individual needs?"; i.e., were these new terms introduced just for appearances in order to bolster pharma's reputation?

Tuesday, July 15, 2014

Total CME Revenue is Up, But Pharma Support is Down (Again) in 2013

The Accreditation Council for Continuing Medical Education (ACCME) 2013 Annual Report is out. Here's the data regarding total CME income and breakdown according to source of income. Note: the data analyzed in this post include income received by BOTH ACCME-Accredited and ACCME-recognized State-Accredited CME providers.

Click on chart for enlarged view.
Let's look more closely at the numbers for pharma support.