Friday, August 15, 2014

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (read "FDA Issues More Guidance Regarding Distribution of Reprints. Is It 'Fair and Balanced?'").

The draft guidance states: "FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study" if the study or analysis meet specific conditions (read about the conditions here).

In a JAMA Internal Medicine viewpoint article published today, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, argues that the draft guidance "suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products" and would "let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling."

Does Wolfe have a case?

Tuesday, August 12, 2014

Why I Will Be Attending Digital Pharma East

Rich Meyer initiated quite a controversy on his World of DTC Marketing blog when he posted a "guest" article by an anonymous "Senior Director for a top pharmaceutical company" who explained why he won't be attending ExL Pharma's Digital Pharma East conference this fall.

Like my friend and fellow conference-goer Zoe Dunn, I have "such a pet peeve with people hiding behind an anonymous post without owning it." It's too bad that some pharma people feel the need to hide their identities when expressing their personal opinions.

Meyer says there are "legal and regulatory roadblocks from his company" that prevent the author from identifying himself! That excuse sounds familiar -- it's the same excuse many pharma marketers have for not doing more in the digital realm despite the fact that their audience is there (read "Pharma DTC Advertising Spend vs. Time Consumers Spend in Various Media").

Before I critique the author's argument, some full disclosure. Pharma Marketing News, which I publish, is a Media Partner for this event, which means that ExL Pharma is a client of mine. In fact, almost ALL pharma conference producers are clients of mine and I get to attend many of these conferences because I get press passes or I get free registration because I am a speaker. In fact, I will be speaking -- for 5 minutes -- at the end of Mobile Day at Digital Pharma East where I will announce the winners of the 5th Annual PharmaGuy Social Media Pioneer Award.

Now, on to my critique. Also, at the end of this post see comments from Jayson Mercado, Head of Digital Events at ExL Pharma. For some reason, Jayson's comments were deleted from the World of DTC Marketing blog.

Monday, August 11, 2014

#mHealthEthics: A Call for Pharma to Develop Mobile Health "Guiding Principles"

According to a "Client Alert" from Pillsbury Winthrop Shaw Pittman LLP, FDA’s new draft guidance that would exempt from premarket 510(k) review many low-risk medical devices may "smooth the path to market for many medical mobile apps that the FDA’s 2013 guidance suggested would be subject to premarket approval requirements."

By "certain devices," the authors mean those that can convert a cell phone into a medical device, such as a thermometer or a stethoscope.

Before the 2013 guidance was released, Bradley Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, thought such apps could be considered medical devices by the FDA. His case study involved a urinary analysis iPhone app -- no, you don't pee on the phone! Listen to this podcast: Beyond Mobile Medical App Guidance - What to Worry About After FDA Publishes Its "Final" Guidelines.

But Pillsbury et al touch on other issues regarding such mobile apps/medical devices:

"All app developers should consider whether their products may face other government oversight or legal challenges. In particular, health information privacy and security is an important aspect of health technology and protection against cyber threats and attacks is crucial. A digitized medical environment, while improving care and access, can be readily exploited by opportunistic hackers. Players in the health IT space should be highly cognizant of this risk and take steps necessary to limit risks to patient safety and the company’s bottom line."

The lawyers, of course, suggest app developers seek legal counsel before marketing their products. But sooner or later Congress is going to be investigating mobile health apps to see if further regulations -- not just FDA regulations -- are required.

Before that happens, shouldn't the pharmaceutical industry (e.g., via  PhRMA) differentiate itself from "wild west" developers by being pro-active in issuing mHealth Guiding Principles for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self-regulatory guidelines such as the DTC Guiding Principles and the Code on Interactions With Healthcare Professionals?

IMHO, the answer is YES! Continue reading to see my list of Guiding Principles."

Wednesday, August 06, 2014

What Types of Health Info Do Mobile Users Seek and Is It Relevant to Advertisers?

You don't hear much about it, but pharma advertises on mobile devices. An Astellas marketing campaign for its overactive bladder drug, Myrbetriq, for example, included an interstitial ad in a mobile app that drove viewers to a mobile-optimized product information Web site (listen to this Pharmaguy Audio Snippet).

So, which medical conditions are most relevant for advertising by pharma on mobile devices? You might think that no matter what the platform -- PC, tablet, or mobile -- users would seek information about the same medical conditions, more or less. Thus, it's a no brainer for mobile advertisers -- just target the same potential patients you do on PCs.

According to an analysis of online impressions from PageScience, a contextual targeting digital ad agency, however, the platform DOES matter.

The top condition on mobile (based on percent of total impressions), for example, is Bipolar Disorder (53% of impressions, versus 36% for PC and 11% for Tablet). PC users, on the other hand, like to access information about cancer (98% of impressions), weight loss (98%), and restless leg syndrome (96%). On mobile, cancer and weight loss garner only 1% of the total impressions.

The table below shows the ranking by % impressions for the top 8 conditions accessed via mobile devices and compares that with PC and Tablet. The list may surprise you!

Tuesday, August 05, 2014

Do PDUFA Fees Encourage Approval of Dangerous Drugs and/or Undermine FDA's Regulatory Oversight of Approved Drugs?

A new study by researchers from Cambridge Health Alliance/Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen, reveals that drugs released after the 1992 enactment of the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, were more likely to be withdrawn or have a black box warning, with 26.7 percent of these drugs receiving such a warning compared to 21.2 percent in the pre-PDUFA drugs that underwent the longer approval process (see press release here).

“The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” said study lead author Cassie Frank, MD, a physician at Cambridge Health Alliance and an instructor in medicine at Harvard Medical School. “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal.”

In recent years, the number of warning letters issued by the FDA regarding Rx drugs has dramatically decreased. Some experts claim that this is due to fewer drugs being approved and marketed. However, is it possible that the rise in PDUFA payments -- which now account for about 65% of FDA's budget for regulation of drugs -- discourages the FDA from monitoring drug promotion and issuing warning letters?

Here's a chart showing the increase in PDUFA funding and decrease in the number of warning letters from 1997 through 2013: