Vol. 12, Issue No. 2: 20 FEBRUARY 2013 – EXECUTIVE SUMMARY 
Welcome to Volume 12, Issue No. 2 (20 February 2013) of Pharma Marketing News. Thank you for being a subscriber. See the featured article summaries below.
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John Mack, Publisher & Editor
editor@news.pharma-mkting.com
@pharmaguy Reigning in the “Wild West” of Mobile Health Apps Will It Be FDA Regulation or Self-Regulation or Both?
In the early days of the Internet hundreds of health Web sites of questionable quality proliferated without any guarantee of accuracy, lack of bias, privacy, etc. Today, thousands of mobile health apps of unknown quality are available for downloading by healthcare professionals and consumers.
As with Web sites in the early days, it is difficult today for users of mobile health apps to be assured that the apps are reliable, accurate, based on valid information, and adequately safeguard users’ information. In many ways, we are living through another digital “wild west” without any sheriffs to protect us.
And it appears that we do need protection.
Topics include:
- Inaccurate Health Apps
- Overzealous FDA Regulation?
- The Regulation of Pharma Health Apps Survey Results
- Good App Privacy Practices
- Test and Document
- Possibly the First Ever “Dear Doctor’ Letter Regarding a Recall Mobile Medical App
- Certification of Mobile Health Apps
- Will Regulation Kill Innovation?
- Self-Regulation: Devil’s in the Details
Download the full text PDF file here:
http://ec2-54-175-84-28.compute-1.amazonaws.com/pharma-mkting.com/news/pmn1202-article01.pdf
Self-Regulation as a Collective Blocking Strategy PhRMA’s DTC Guiding Principles Taken to Task
PhRMA first issued its Guiding Principles for Direct to Consumer (DTC) Advertisements in August 2005, and revised them in March 2009. The principles are only “guidelines” — not rules — and signatory companies agree to “voluntarily” follow them.
Has the drug industry systematically violated PhRMA’s DTC Principles? Is pharma self-regulation a deception meant to deflect criticism and block new FDA regulations? The answer is “yes,” according to a study recently published in the Journal of Health Politics, Policy and Law. The study authors provide convincing evidence, which is summarized in this article.
Topics include:
- PhRMA’s Lax Accountability Regime
- The Appropriate Audience …Not!
- Deflecting Regulations
- Collective Blocking Strategy
- Enactment of New Laws Were Blocked
- Policy Recommendations
Download the full text PDF file here:
http://ec2-54-175-84-28.compute-1.amazonaws.com/pharma-mkting.com/news/pmn1202-article02.pdf
Will Ethics Revive (Exhume?) the Drug Industry’s Reputation? Excellence in Ethics Accreditation Proposed for Pharma
We all know why the drug industry has a bad reputation. For one thing, it has been found guilty of unethical and even unlawful practices that include hiding clinical trial data and illegally marketing drugs. How to improve the industry’s reputation is a perrenial question.
So it was with great interest that I read about a new effort to improve the drug industry’s reputation: the establishment by a bioethicist of an accreditation rating system.
Jennifer Miller, a fellow at the Edmund J Safra Center for Ethics at Harvard University and president of Bioethics International, a non-profit that advises educational programs on ethical issues on medicine and healthcare, is trying to develop the industry equivalent of a “Good Housekeeping Seal of Approval.” This article summarizes her ideas and presents opinions of several naysayers.
Topics include:
- A Pharma Industry Seal of Approval
- Achilles’ Heel: Credibility of the Seal
- Excellence in Ethics Accreditation
- Volunteers Needed
Download the full text PDF file here:
http://ec2-54-175-84-28.compute-1.amazonaws.com/pharma-mkting.com/news/pmn1202-article03.pdf
