FDLI Conference Part 3 – Wrap Up of Day 1

Following her speech, during question and answer, I asked Dr. Woodcock the question that was left on the table following her outline of FDA's direction.  I applauded the announcement about the FDA holding a public hearing on social media, but observed that the process to develop a guidance was going to take several months and that (1) brands of both companies and products are being shaped in the social media environment now and (2) the benefactor of DDMAC's social media policy to date on paid search ads has had a net negative public health consequence by allowing more hits for snake oil salesmen who can now have the territory to themselves – what, if anything, would FDA be doing between now and the time that a Guidance is issued, to provide insight for industry.

She acknowledged that government moves slowly but said that the development of a Guidance was an FDA priority, which is a surprising statement given their prior position on the issue.  But as to the substance of answering the question – she punted to Dr. Abrams, who did not answer the question during his panel – a panel that merely reviewed enforcement actions by FDA.

For the most part, looking backwards and not forward was a theme for the balance of the day.  FDA also reviewed the Draft Guidance for Industry on the presentation of risk information and DDMAC reviewed some warning letters and why they were issued.  It was rather fascinating to hear a DDMAC spokesperson review a commercial for Avodart that showed a man demonstrating prostate shrinkage by showing two different sized planets.  DDMAC's problem with this is that the shrinkage shown in the footage was not proportional to the actual shrinking of the prostate when a patient is using Avodart.  Really?  The FDA spent time and money and valuable resources to investigate and correct that with an untitled letter?  Really?  They must have too much time and money on their hands because this mis-step could hardly be a public health priority in the face of so many other issues upon which DDMAC could be active.  Check out the violative material here. If the intention was to show DDMAC's willingness to enforce the letter of the regulation, it succeeded.  If it was intended to show good enforcement priority setting at the agency, it failed.  

At lunch, John F. Kamp, the Executive Director of the Coalition for Healthcare Communication an of counsel to Wiley Rein both entertained and informed the crowd with an overview of what is shaking on Capitol Hill with respect to health care reform and discussed provisions that would affect the ability of companies to expense marketing costs, among other issues.  He then went on to chair a panel that included Mike McCaughan from the RPM Report who provided an interesting hypothesis about the role of REMS programs and the possibility that REMS may take on a greater role by those who are responsible for marketing in medical product companies.  

I had hopes that a panel on the use of social marketing and electronic media would preview for FDA what they would probably hear at the November 12-13 public hearing.  But the panel reviewed some statistics (some outdated) about social media use and one speaker once again reiterated what pharma can't do, as opposed to what they can be doing.  And the (I think) red-herring issue of adverse event reporting once again made its presence known. 

The absolute best speaker of the day was also the last speaker of the day – Nathan G. Cortez, Assistant Professor of Law at the Dedman School of Law, Souther Methodist University.  He gave a very compelling talk that followed an overview of industry codes of conduct by PhRMA and AdvaMed that put forth the notion that for all intents and purposes, thesec

 codes of conduct probably now have created a legal standard.  And as a result, if a company fails to adhere to the codes, then legal liability could flow.  It, along with John Kemp's luncheon discussion,  was the most forward looking talk of the day.  

Today, I'm determined to find an electrical outlet!