FDA and Social Media: Much Ado About Nothing

Posted in Social Media, Uncategorized

Since the inception of blogs, Facebook, Twitter, YouTube and other social media platforms, many life sciences companies, mainly big pharma, have been anxiously awaiting regulatory guidance from the US Food and Drug Administration on how to use them. Interestingly, FDA did issue some guidance in 2012 on it use last year but many drugmakers felt that it was insufficient and not detailed enough.  Despite the lack of clearly defined regulatory guidance, many companies took the social media plunge anyway. And according to a recent survey of regulatory actions and letters conducted by Mark Senak author of the fabulous EyeonFDA Blog the agency has done very little to thwart the social media strategies implemented by drug companies. In fact, there has been no obvious increase in the number of warning letters or violation letters regarding the use of digital or social media as compared with traditional media violations.

Senak drew this conclusion after analyzing 173 warning and notice of violation letters (advertising and media related) that were issued by the agency from 2008 to 2012.  Of the 173 regulatory letters that were issued, 675 violations were cited and only 43% involved digital media.  And, for the most part, most of the cited violation had little to do with the digital or social media vehicle used but more to do with the message being delivered. For the full report click here.

What does this all mean? While it is difficult to draw any firm conclusion, I believe that the bottom line is that the importance and significant of the long awaited FDA guidance on the use of social media has been overstated. Put simply, if you follow the existing rules guiding advertising and print media, companies ought to be able to craft a regulatory-compliant social media communication strategy without the fear of running afoul of the agency.  Those who violate the existing rules will likely be caught and have to clean up their acts.

The bottom line. Many drug companies have been able to mount very effective social media campaigns without getting into trouble with FDA.  The key to success is following the rules and implementing a digital/social media campaign that has passed internal regulatory muster to insure that everything is in order and regulatory compliant. Companies that have made the investment into digital/social media will be successful whereas others that jump into the game without taking the time to understand the rules of engagement will fail.

Until next time…

Good Luck and Good Job Hunting!!!!



A Death Knell For Social Media and Pharma?

Posted in Social Media

For the past few years, I along with many others have advocated the use of social media platforms (mainly Facebook, Twitter and YouTube) by life sciences companies. Despite a very positive beginning by companies like Novo Nordisk, Johnson and Johnson and others, the implementation of social media in the life sciences industry has been stymied by a lack of regulatory guidance by the US Food and Drug Administration (FDA) and legal and commercialization concerns. While many believe that FDA guidance on the topic will be the panacea that they were waiting for, I personally don’t believe that it will make one bit of difference. That said, Steve Woodruff, the author of the IMPACTIVITI Blog, provides one of the best analyses that I have encountered that explains why social media and pharma don’t work well.

In a post entitled “Time to Give Up on Pharma and Social Media,” Steve cogently provides four compelling reasons why it will be difficult for pharma to ever embrace social media for commercial purposes. They include 1) the lack of regulatory guidance; 2) pharma does not communicate or interact in real time; 3) personnel turnover, short term thinking, lack of innovation and too much focus on quarterly profits; and 4) pharma’s addiction to centralized, one-way controlled communications. His bottom line:

Public, interactive, real-time social media platforms and commercial pharma communications simply don’t mesh well 

While I agree with Steve that social media may not be ideal for commercial purposes in the prescription life sciences industry, it may be perfectly well suited for pharmacovigilance and adverse event reporting, clinical trial recruitment and management, education, community outreach and employee recruitment and retention. These are not new ideas. But, because they cost money to implement and don’t contribute the most company’s revenue-driven bottom lines, life sciences companies have not actively explored or embraced them for these purposes. 

Whether big pharma and biotech companies like it or not, social media is here to stay. And, if these companies fail to act soon, they eventually will begin to lose their competitive edges and perhaps more importantly, market share. 

Until next time.. 

Good Luck and Good Job Hunting!!!!!!!!



FDA Enters the Digital Age by Issuing 22 Warning Letters to Web Site Operators

Posted in Social Media

The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell….hopefully sooner, rather than later!

Until next time…

Good Luck and Good Surfing!!!!!!!!!


Its Official: Health Informatics is One of the Hottest New Career Options for LIfe Scientists

Posted in BioJobBuzz

I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. 

As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill sets. Getting a nursing degree is one of the steps to achieve a great career in health informatics!

Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

  • The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
  • The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
  • The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Again, getting a nursing degree is one of the steps to achieve a successful career in health informatics

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time….

Good Luck and Good Job Hunting!!!!!!!


Upcoming Conference on Social Media and Digital Health

Posted in Social Media

For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!


Mining Prescription Drug User Data

Posted in Career Advice

I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time…

Good Luck and Good Job Hunting!!!!

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