– apologies for the whacky formatting issues. Typepad is being quite
agenda is full. Sadly, it is not full of medical product
companies. Industry is outnumbered by public relations firms, ad firms,
and bloggers. Lots of potatoes, not much meat.
Pew Charitable Trusts opens the meeting with Allan Coukell of the Pew
Prescription Project who tried to cram so much into his five minutes of
commentary that the salient points were run together so quickly that they were
almost lost. Within a few minutes however, he did shoot down PhRMA's
idea, to be later presented, that FDA create a "logo" system to
identify approved and safe information. He also cited marketing
activities currently underway on the Internet that do not meet fair balance and
do not supply adequate risk information – particularly noting games that have
become popular on the Internet by some pharmaceutical companies.
ever-entertaining John Kamp from the Coalition for Healthcare Communications
countered with the idea that the FDA create FRIs – FDA Regulated Information –
being sites where the public could go to find information about medical
products that has been screened and approved.
centered their comments
on the fact that while consumers and patients are turning to the Internet more
and more to gain insight into their treatment choices, pharmaceutical
companies, who have engaged in research on those treatment choices, have been
unable to fully participate in social media and the Internet because of a lack
of clarity from the FDA as to their obligations and responsibilities.
Lilly has avoided
significant interaction because of a lack of clarity of FDA’s
expectations. Lilly says they have been asking the same questions that
FDA is asking and doesn’t have the answers but suggests that FDA hold more
frequent workshops to address emerging issues, citing the emergence of Sidewiki
as an example a development where the company can’t make policy decisions on
how to deal with it because there is a lack of guidance from FDA about the
implications of any decision they would make.
That sums it up and is really the gist of the meeting. Lilly hit it out of the ball park – they showed real leadership here today with cogent and relevant, meaningful commentary.