Category Archives: Regulatory

Social Media Mistake

KKImagewDrugI usually skip over the Kim Kardashian (KK) articles in the press but this one caught my eye because it mentioned the FDA.

It turns out the well-known celebrity had taken to social media in a sponsored Instagram post about the morning sickness drug Diclegis made by Duchesney. For those of you not up on tabloid news, KK is pregnant with her second child.

Because the Instragram post was the result of a formal partnership with the drugmaker, Duchesnay, the post should have met the requirements of drug marketing which requires substantial additional information and warnings about use.

The FDA notified Duchesnay of the violation of its online advertising rules. In response, Duchesnay promptly organized a second Instagram post from KK with lengthy disclaimers attached.

This incident highlights drugmakers’ emerging awareness of the value of social media especially using such powerhouses as KK but also the rules which must be followed.

The FDA has been proactive in issuing guidance for companies and products under its supervision as to the use of any online media, as described in a prior article (click here)

As this prior article notes, much of the information available online is not directly produced by or even under any control by the product’s maker.

If KK’s Instagram post had been a spontaneous expression of KK’s opinion of Diclegis and not a formal promotional campaign, there’s little that the FDA could have done.

Online information about medical devices and drugs remains a “wild west” running the gamut of disciplined FDA-guided marketing and completely unsupported opinions masquerading as medical information.

To read the article about KK’s Instagram adventure, click here.

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Marketing Off-label Drug Use

RedWrenchA Federal District Judge in Manhattan just threw another wrench in the Food and Drug Administration’s (FDA) enforcement mechanism.

The court decision said the FDA could not prohibit the truthful promotion of a drug for unapproved uses because doing so would violate the protection of free speech.

This decision is the second in a string of cases chipping away at a powerful weapon wielded by the FDA which requires drug companies to obtain FDA approval before promoting a specific use of a drug.

Physicians commonly prescribe drugs for uses other than for which drugmakers have obtained FDA approval, but the FDA has taken the position that it is illegal for drugmakers to actively promote that “off label” use.

This recent decision and the prior decision squarely challenge the FDA’s position.

Drugmakers are likely to proceed cautiously. No doubt the industry will be watching for additional challenges by drugmakers to further define the groundrules.

To read an article in the New York Times on the issue and this recent case, click here.

FDA Guidelines for Medical Product Information Online

SisyphisImageSearching for medical product information online is generally a frustrating experience with the occasional gem of discovery.

The Internet is the newest “wild west” with seemingly little to no regulation of content.

Because online information can and should be a valuable source of medical product information, the FDA has issued a set of guidelines for (i) medical product information in limited space formats (think Twitter) and (ii) fixing incorrect medical product information online.

With so many independent sponsored sites of medical product information online, the task to “clean up” the internet is immense and well beyond the scope of these first guidelines.

Is it a good first step or an impossible task?

Click here for an article by the law firm, Searcey Denney, on JD Supra, the online magazine.

Marketing Unapproved Uses

ReprintCartoonA life science company’s marketing of unapproved or “off-label” use of drugs and devices has been regulated largely by the FDA’s 2009 Guidance.

On March 3, 2014, the FDA issued new 2014 Draft Guidance which clarifies certain rules and requires life science companies to provide additional detailed information.  The comment period on this 2014 Draft Guidance runs to May 2, 2014.

Latham & Watkins, the law firm, has prepared a helpful article on the regulatory history of “off-label” marketing as well as the important elements of the 2014 Draft Guidance.  Please click on the button below to download the Latham & Watkins “Commentary”.

Download the PDF

Anti-trust Calculation Includes All Patent Rights

Our friends at Bryan Cave have prepared the following update.




The Federal Trade Commission (“FTC,” together with the Department of Justice Antitrust Division, the “Agencies”) has published its final rule implementing amendments to its regulations under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR Act” or “Act”).

The amendments, which will become effective on December 16, 2013, provide that the transfer of exclusive patent rights in the pharmaceutical industry may be reportable under the HSR Act where “all commercially significant rights” to that patent, for use in any therapeutic area or indication, are transferred.

While it has long been the Agencies’ position that transfers of exclusive patent rights can potentially be reportable under the Act, the amendments formalize that approach and also clarify that the retention of limited manufacturing rights or co-rights does not impact the potential reporting obligation that may arise as a result of the proposed transfer.

Read more.

Unique Device ID Rules Issued

OperRoomThe FDA has produced its Final Rules implementing its unique device identifier to establish a consistent labeling system for devices and facilitate its postmarket surveillance plan.

Most devices will fall under the plan for which implementation will be mandated over the next 5 years.  Most Class III, high-risk medical devices must comply by September 24, 2014.  Most Class II devices, moderate-risk devices have three years and those Class I, low-risk devices have five years to comply.

The Final Rules also specify the Global Unique Device Identifier Database, the FDA’s publicly searchable database,  to which the device manufacturers submit device code information.

Click here for an article from the law firm, Baker Hostetler.

Click here to read the FDA Final Rules. 

Post by Dennis McCarthy


Healthcare Supplier Performance Less Predictable

disruptionHealthcare industry-wide cost containment behavior is sending ripples back through the supply chain.

Are the changes a transitory event or a trend is the question facing many suppliers.  Does the change call for a permanent change to business as usual?

As unsettling as it may be, most suppliers appear to be preparing for a transition which will bring more variability and unpredictability to the results of companies which had been prized for dependability in results.

The speed with which suppliers adapt to the new environment may influence the degree of variability.  Resisting what appears to be an inevitable transition likely accentuates the disruption it causes.

As I listen to Wall Street earnings calls, healthcare industry suppliers blame weak results on cost cutting but rarely admit to what is likely the new reality.

Click here for an article by Chris Provines, author and speaker, on healthcare supplier strategies.

Click here for an article in Modern Healthcare suggesting the greatest pressure is on commodity items.


 Post by Dennis McCarthy


Provider InfoTech Pressure

CTGlogoJust when healthcare providers are facing intense cost pressures in essentially all activities, comes increasing demands for critical information technology upgrades.

CTG Group, which provides IT consulting for the healthcare industry, summarizes many of these technology upgrade activities.

Click to go to the article.

 Post by Dennis McCarthy


Mobile Apps Require FDA Review

SmartphoneAppsThe Food and Drug Adminstration, FDA, has provided final guidance to determine which mobile apps may require FDA scrutiny and regulation.

The more the mobile app’s intended used is as an integral part of the functioning of a medical device, the more likely it falls within regulatory scrutiny.  For example, a mobile app used to read the results of diagnostic tests are likely to be defined as a “mobile medical app” and, therefore, face FDA review.

At the other end of the spectrum, mobile apps that are used for normal office functions such as scheduling office visits or reminding patients about non-medical behavior such as getting sufficient exercise, are unlikely to face review.

Click on the links below or copy and paste the links into your browser to read a helpful summary of the FDA announcement by Foley & Lardner, the law firm, or the FDA guidance.
 By Dennis McCarthy