September 16, 2008
As I see it
Although feelings in the mainstream drug industry will be mixed, it's time to end the secrecy that surrounds the FDA's decision-making on approving drugs.
Initially legislated to protect trade secrets and then expanded by the agency itself in Nixon-era regulations to broadly protect info deemed commercial/confidential, the prohibition prevents FDA staff from even acknowledging the existence of a pending application, much less address decision-making.
Coexisting with Securities and Exchange Commission requirements that compel drug companies to disclose significant FDA preapproval review developments that could impact stock prices, the ban at the FDA is made ridiculous and harmful by real-time realities of the Internet. For current evidence of this, read Matthew Herper's article, The FDA's Black Box in Forbes magazine, where he discusses the investor- and company-harming negatives of the FDA's rejection of 10 drugs against favorable advisory committee recommendations.
Were they duds or narrow misses? Nobody could say, objectively. In none of these cases did the sponsor release the FDA's rejection letter.
But while they may be masters in marketing communications, few corporations have the gift of clairvoyance in foretelling how their critics and the media will manipulate their carefully crafted disclosures.
The FDA, meanwhile, is left mute by its self-inflicted prohibition. This may be how some sponsors prefer it remain, since an unmuzzled FDA would end their control of what the public knows about their future product's problems.
Forward-thinking sponsors please step forward!
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)