Tag Archives: warning letter

Pharma Petitions FDA for Binding Off-Label Rules


Eliminating illegal off-label promotion while engaging in legal scientific discourse around unapproved uses to ensure patient safety is a difficult line to walk for medical device and pharmaceutical companies. Today, the current broadly-written laws are open to expensive and retrospective interpretation delivered by the FDA, DOJ  and HHS via detailed warning letters, untitled letters, CIAs and DPAs. This is unproductive.

Seven pharmaceutical companies filed a Citizen Petition to FDA for Off-Label Guidance on July 5th Continue reading

Regulatory and Marketing Symbiosis from Concept to Commercialization (SLIDES)


Recently two Good Promotional Practices’ bloggers, Elsa and I, gave a live webinar for the Regulatory Affairs Professionals’ Society (RAPS), Regulatory and Marketing Symbiosis from Concept to Commercialization: A Good Promotional Practice. It was a fascinating topic to be invited to speak on and fun to create and present. There was much interaction during the webinar, so we would love to hear your input and questions as well. Here are the slides: Continue reading

Happy Anniversary for FDA Bad Ad


In November 2010 we reported on the FDA’s Bad Ad Program, which asks physicians to anonymously report misleading advertising and off-label promotion by pharmaceutical sales representatives. Last March, Doctor Directory, a leading market service company for the healthcare industry, conducted a survey to measure physicians’ attitudes toward the initiative. 90% of over 1,000 practicing physicians said that they would be at least “somewhat likely” to report questionable behavior. Now, just in time for the 1st anniversary of the Bad Ad Program, the FDA has released their results of the measure thus far. Continue reading

Social Thoughts from RAPS 2010, Part II

Author: Elsa Abruzzo

As many of you may know in November 2009, FDA conducted an open Public Hearing to solicit public comments on promotion of FDA–regulated products using internet and social media tools.  The comment period to the Docket closed on February 28, 2010 and FDA expressed that having a guidance by the end of 2010 is a priority.  Glenn Byrd suggests we ask ourselves a couple of questions in the interim –   “What is our risk tolerance?” and “What do we want to achieve with internet and/or social media tools?”  With respect to the latter, are we looking for brand, disease or corporate focused communications?   Byrd also urges industry to listen to their various audiences and apply exiting regulations and guidance.  He specifically lists some oldie-but-goody pearls of regulatory wisdom: Continue reading

Social Thoughts from RAPS 2010, Part I

Author: Elsa Abruzzo

It has been a busy couple of weeks; I’ve been doing some business traveling and in parallel amassing more hot-off-the-press material for our GPP Blog.   Last week I was in Buenos Aires (BA) where there was no FDA presence, but there was fantastic food, polo matches, and tango receptions (yes, my friends the Argentineans can host a superb medical conference).  In addition to the fun, I was working on how the big medical device firms can market to their international customers very differently than they can to their US counterparts—maybe fodder for another blog post.   However in the Spirit of FIFO (first-in-first-out), the focus today is my trip the week before to San Jose, CA for the Regulatory Affairs Society (RAPS) Annual Conference and Exhibition. Continue reading