In advance of a second FDA’s advisory committee on Avandia and Deputy Commissioner Josh Sharfstein’s testimony on drug safety (this Wednesday in front of a House Energy and Commerce subcommittee on drug safety) comes this front page missile from BioCentury: “End the War.”
Here’s a taste:
The firestorm over GlaxoSmithKline’s Avandia (rosiglitazone), which was rekindled two weeks ago with an incendiary Senate report, shows why people who live outside the Beltway are convinced that Washington is broken, and why they are right.
The politico-media outburst exemplifies the worst aspects of the American regulatory environment. It also exemplifies why business as usual in Washington must stop, and why the responsibility rests directly at the feet of the politicians and regulators who are failing their responsibility to put the public’s health before politics.
As with previous rounds in the Avandia circus, grandstanding members of Congress played gotcha with FDA, releasing their report to the agency and to the media simultaneously. Citing data from disgruntled FDA employees, Committee Chair Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) said in a Feb. 20 press release that “the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.” The release gave the false impression that this represents FDA’s official position.
Unless the political leadership at HHS and FDA acts quickly and decisively, decision-making based on external political pressure and a paralyzing precautionary philosophy will become institutionalized.
Instead of being occasionally blown off course by recurring squalls, the very real risk is that permanent climate change will forever degrade FDA’s science-based over-sight process, eroding the public’s confidence in the agency and placing a stop sign on the path of biomedical innovation.
Avandia is the poster child for a culture that has evolved at FDA — encouraged by publicity-seeking politicians — in which agency employees who dislike a regulatory decision are able to keep raising the issue, and if they don’t like the results, to go outside established agency procedures for resolving scientific disputes to enlist support from members of Congress and their enabling lapdogs in the media.
There’s more. A lot more. Names are named. And punches aren’t pulled.
The complete BioCentury commentary can be found here.
Here’s a taste:
The firestorm over GlaxoSmithKline’s Avandia (rosiglitazone), which was rekindled two weeks ago with an incendiary Senate report, shows why people who live outside the Beltway are convinced that Washington is broken, and why they are right.
The politico-media outburst exemplifies the worst aspects of the American regulatory environment. It also exemplifies why business as usual in Washington must stop, and why the responsibility rests directly at the feet of the politicians and regulators who are failing their responsibility to put the public’s health before politics.
As with previous rounds in the Avandia circus, grandstanding members of Congress played gotcha with FDA, releasing their report to the agency and to the media simultaneously. Citing data from disgruntled FDA employees, Committee Chair Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) said in a Feb. 20 press release that “the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.” The release gave the false impression that this represents FDA’s official position.
Unless the political leadership at HHS and FDA acts quickly and decisively, decision-making based on external political pressure and a paralyzing precautionary philosophy will become institutionalized.
Instead of being occasionally blown off course by recurring squalls, the very real risk is that permanent climate change will forever degrade FDA’s science-based over-sight process, eroding the public’s confidence in the agency and placing a stop sign on the path of biomedical innovation.
Avandia is the poster child for a culture that has evolved at FDA — encouraged by publicity-seeking politicians — in which agency employees who dislike a regulatory decision are able to keep raising the issue, and if they don’t like the results, to go outside established agency procedures for resolving scientific disputes to enlist support from members of Congress and their enabling lapdogs in the media.
There’s more. A lot more. Names are named. And punches aren’t pulled.
The complete BioCentury commentary can be found here.
