Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI

The Petrie-Flom Center Staff FDA, FDA in the 21st Century Conference, Holly Fernandez Lynch, Petrie-Flom Center

[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the media and Congress.

Susan began by contrasting media past and present – from newspapers, radios, and TV news, today the agency has to contend with the range of issues and challenges associated with social media.  There has been a shift from dealing with a defined press corps focused (and expert) on FDA to a “media of the masses,” which requires some level of training and background on the agency’s mission and intricacies.  The agency can now also speak directly to the public, and be more proactive, without the filter of reporters and news media editors.

Associated with this media shift, Susan identified several new realities and challenges:

  • How to explain complex scientific and legal issues in 140 character tweets?
  • How to speak with “one voice” despite the fact that every agency employee now has a media outlet?
  • How to address the expectation that FDA make declarations in real time, giving immediate responses to new developments? 
Susan then moved on to discuss the various ways in which congress engages with and influences the agency, beyond amending the FDCA:
  • (1) The user fee cycle has created a situation in which a “must pass bill” moves through congress every 5 years (and in fact, more frequently given that not all of the user fee acts are on the same reauthorization schedule)
  • (2) Congress also intervenes on occasion to seek expanded access to drugs for certain individuals, often in very high profile situations
  • (3) Congressional investigations can be helpful, but require substantial agency resources, which can be challenging when investigations occur concurrently with a pressing public health issue; investigations can also be intimidating to agency staff
  • (4) Senate confirmation of FDA commissioners creates an avenue for input on very specific issues, e.g., RU486, prescription drug importation, Plan B, etc.
  • (5) Congressional hearings, like investigations, can be both illuminating and intimidating, and also require a great deal of work to prep – for example, between 2006-2007, there were 55 congressional hearings with an FDA witness, meaning that about every other week, FDA resources were being devoted to these meetings
Susan concluded by describing a few new realities.  First, she expressed the concern that since we can expect user fee act reauthorizations two of every five years going forward, there is a risk of creating an increasingly prescriptive statute.  There is also a “gap year problem” – in those years where there is not a reauthorization on the docket, there is not much appetite for other types of potentially crucial FDA reform.  She called on congress to figure out a way to avoid the tendency toward theater for theater’s sake, so that hearings and investigations can be most productive, although of course not necessarily pleasant.  Susan emphasized that FDA needs additional resources for a variety of things, but also to meet new communication demands, including the need for  continuous and clear messaging, all in an environment of scientific and (sometimes) legal uncertainty.
During the Q&A period, Susan addressed additional challenges related to social media, including difficulty determining what the agency needs to say and, often as important, when the agency needs to or should speak. She also agreed that it may be helpful to consolidate user fee reauthorization schedules, and expressed concern about unfunded agency mandates.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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