Influence Intelligence

The FDA -- A Killer Controversy

Always-provocative Fox pundit John Stossel expounded on the FDA's intention to regulate physician smartphone apps in his column last week. New apps are making it possible for docs to monitor patients from afar, with the same level of informational visibility they would have bedside.

The FDA is concerned these apps might be mistake prone and lead to misdiagnosis or inaccurate treatment. Understandable, says Stossel, but also unnecessary.

. . . the FDA basically says, "No, you just can't put something on your phone if it's a medical device. What if it doesn't work right? We have to approve it first."

That caution makes sense to people. Our first instinct is to say, "I don't want someone getting rich off a device that might not work right. It might kill me. I want the FDA to make sure everything is safe and effective."

But lawyer Jonathan Emord says our instinct is wrong.

"It is wrong because these regulations are costly, burdensome, and they prevent essential medical apps from getting into the marketplace," Emord said.

Emord's insights are worth weighing. In today's medical environment, rife with time constraints and cost consciousness, we need to empower physicians. Encouraging them to be innovative means they will better meet patient needs.

Burdening docs with more regulation and restriction ultimately costs patients. Let's stop inhibiting the healthcare industry and instead encourage efficiencies that ultimately help all.

The High Price of Cutting Corners - Improper Investigation an Issue at Ben Venue

An attention-getting read in today's Pharmalot illuminates the reasons why a division of Boehringer Ingelheim, the Bedford Laboratories unit Ben Venue Laboratories, was contending with what it classified as "capacity constraints". The reasons were tied to quality control:

In fact, we learned that inspectors from both the European Medicines Agency and the FDA visited its facilities and cited Ben Venue for various deficiencies at one specific facility that contributed to production slowdowns . . . the FDA issued a 483 inspection report last May . . . [that] contains a laundry list of problems, many of which Ben Venue failed to properly investigate . . . 

The takeaway? With the shortage and price constraints it will be harder and harder for manufacturers to keep up with quality standards.  This should be apparent throughout the industry: You can't cut corners where quality of medicine is concerned.

Pharma Social Media Dust Up Could Use a Dose of FDA Guidance

Monday's edition of AdvertisingAge added interesting perspective to the dialog about Big Pharma's need for social media transparency. As explained by author Leigh Fazzina:

Given that eight in 10 internet users are looking online for health information, according to the Pew Internet & American Life Project, it is imperative that the U.S. Food and Drug Administration finds a solution to its ongoing battle to provide timely and relevant guidelines for pharmaceutical social-media communications and marketing.

This comes on the heels of Facebook's recent decision requiring pharma companies to enable user comments on their FB pages.

Which leads us to wonder: How can the pharmaceutical marketing, communications and public-relations sectors advance in the digital age if the very Federal agency that regulates their communications is failing to properly advise them?

Fazzina explains the situation well:

It is no surprise that health-care companies with practical information about treatments are eager to be where the patients already are -- active in social media and social networking. However, the FDA's repeated delays in issuing guidance on the use of social media leaves many stakeholders in the lurch. 

To echo Fazzina's point, this becomes a classic case of "damned if they do/damned if they don’t." Companies move forward with zero guidance, trying to communicate through the right channels, only to be told how to interact after they're underway.

Unfortunately, this happens all the time.  Digital information and the right to embrace it are problematic if you have no notion of how you will be treated, or what expectations you are obligated to establish. It's a familiar cycle.

One again, this industry is seeing repercussions from engaging in what were thought to be best practices. Some FDA education and understanding up front rather than after the fact might make a big difference.