Tag: regulatory consulting

Pfizer Goes It Alone on Social Media

Posted on by Valentina Rosa

I wrote a blog post on December 22 entitled “FDA Misses Own Deadline On Social Media.” Some Big Pharma companies like Pfizer are defining their own rules rather than waiting for the agency to deliver their guidance in the first quarter of this year. According to an article on BNET by Jim Edwards, Pfizer has just developed its own social media playbook along with a blog response flowchart based on a version used by Pfizer Canada that was originally developed by the U.S. Air Force in December, 2008.

Edwards said that Kate Bird, Pfizer’s digital communications strategy director, said “Twitter is really the most-used channel for any type of crisis communication.” She indicated that the playbook was introduced because “We don’t want them to be intimidated and afraid of it. It’s part of our everyday life. It’s only going to become an even greater part of our everyday life.” (1)

While Pfizer’s playbook and flowchart aren’t rocket science, it does show that Big Pharma is moving forward with social media without the FDA. And Pfizer’s not alone or the first to do so. Roche created its own social media playbook in August 2010.

Notes

(1) Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Resources

Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Pfizer Canada shares its social media response flow chart

The Air Force’s Rules of Engagement for Blogging

New FDA Guidance on INDs: What You Need To Know

Posted on by Valentina Rosa

The FDA typically issues a new guidance when the agency is seeing errors in submissions and a lack of understanding in industry and academia. Most recently, the agency observed these trends regarding when and why the academic research community and industry must prepare an Investigational New Drug (IND) application before studies of a drug or biologic can begin in human subjects. In response, FDA released a new guidance document in October 2010 entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted without an IND.” The document totals just 19 pages.

Clients in our regulatory consulting & writing practice have told us that the new guidance provides an understanding of:

  • Three characteristics of research studies that create an IND requirement
  • Six criteria that must be met for a clinical investigation to be IND-exempt
  • When and if studies on healthy volunteers or studies using only a few subjects require an IND
  • When studies conducted outside the U.S. require an IND

Our clients also found the “Frequently Asked Questions” at the end of the guidance extremely valuable.

After reading the new guidance you should be able to create a checklist and determine whether your study requires an IND. Spend the time, read the guidance, and make a plan.

FDA and Life Sciences Relationship: PwC’s Improving America’s Health V

Posted on by Valentina Rosa

Starting in 1995, PricewaterhouseCoopers (PwC) has surveyed the life sciences industry on its working relationship with the US Food and Drug Administration (FDA), its chief regulatory agency. This year’s fifth survey produced mixed results for industry and the FDA. See the PwC press release for more information.

Among the six key findings described in the Executive Summary, four seem especially important for regulatory writers (1):

  1. Despite complex scientific, economic and political changes, the relationship has improved; but problems remain. 78% of respondents said that the agency’s guidance documents have increased industry’s understanding of FDA’s expectations. I know from first-hand experience that this has been a major initiative by the FDA over the past 3-4 years. FDA personnel regularly speak at events sponsored by the Drug Industry Association (DIA) and Regulatory Affairs Professionals Society (RAPS), two of the largest professional organizations for regulatory writers and regulatory personnel. However, problems persist as 30% of respondents saw no change in the agency’s approval process over the last two years, and more than 60% said that the FDA changed its position during their review. Working with a number of biopharma customers at TRA360, this is a consistent issue and one the agency needs to address. Better training, oversight, and assessment seem like valuable areas for improvement.
  2. FDA approval process lags in both scientific and technological advances. Industry feels that the agency is not keeping up with technology, something we hear from our customers, vendors, and regulatory consultants all the time. Part of this is the usual industry-government divide, but in my opinion, both parties need to work harder to bridge the gap. Joint initiatives have been underway for years, but more creative solutions are needed.
  3. More frequent, open and clear communications could benefit both sides. After 10+ years as a regulatory professional, this is no real surprise. Industry needs to do a better job at scheduling meetings with FDA—pre-submission and end-of-phase—and FDA needs to be more proactive in requesting them. And FDA needs to work hard to standardize submission requirements throughout the development process, especially in the endgame when delays or failures are more expensive.
  4. Opportunities abound to improve America’s health. Increased collaboration between industry and the FDA are essential here, especially with regard to the agency’s high stakes, all-or-nothing approach to drug approval. Based on my experience, regulatory professionals can be key players in successful outcomes here.

Overall, I found PwC’s Improving America’s Health V an insightful survey, rich with important data for biotech, pharma, and medical device companies, regulatory professionals, regulatory writers, medical writers, and medical communicators. The complete findings of the study and a podcast on the report are available for download at: http://www.pwc.com/us/fdasurvey.

(1) Improving America’s Health V, http://bit.ly/ekbSxf, page 3.