Signs are everywhere that Washington is preparing for the next administration, whatever color it may be. As key Bush appointees either resign or plan their next jobs, regulatory agencies begin showing new activity after seven years of inertia.
At the FDA, this comes partly in reaction to an awakened Congress, partly in response to widening public disquiet over the agency’s inability to protect against contaminated imports, and partly out of White House recognition that its window of opportunity to make lasting changes at the agency is closing rapidly.
Like a sprung trap, the Bush-era cap on new regulatory initiatives was released in October. With mind-numbing speed, the FDA took only six days from presidential signature to put into effect an FDA Amendments Act provision authorizing it to set up an industry-funded foundation to help expedite product innovation.
Traditionally, the FDA has taken many months, and sometimes years, to act on new congressional mandates. The agency’s Janet Woodcock rose with unusual boldness to counter complaints that the new foundation could sneakily increase industry’s influence over FDA scientific decision-making. Rep Rosa DeLauro (D-CT) demanded the agency stop working on it. As the FDA was speeding in that direction, DDMAC took less than two months to establish the same legislation’s new TV ad review user-fee program, set its $41,390 submission fee, receive 18 submissions and complete six of them within the 45-day statutory deadline. Then the FDA was found—after decades of opposition to the very idea—to be secretly working on a plan to allow drugmakers to distribute peer-reviewed literature on off-label indications.
It’s a very different game leading up to the next Inauguration Day.
Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the January 01, 2008 Issue of MM+M - Medical Marketing and Media
