October 13, 2008
As I see it
Add to all the other Washington unravelings of the past nine years the loss of FDA innocence. This agency was once second to the National Park Service in public respect.
The FDA's fall was barely noticed when it began with the first politically directed drug approval: the abortion pill, RU-486 (Mifeprex). Then came the first politically directed drug disapproval in 2006, the OTC Plan B morning-after pill for high school girls.
An accelerating pace of scandals followed, including no-bid insider contracts for information technology and polishing the agency's battered public image.
Infusions of new top managers with political and industry connections introduced out-of-the-box, innovative ways of getting around budget cuts, including outsourcing FDA programs.
It's always puzzled me how outsiders can make profits from doing contracted government work and their bill still saves the government money.
Nevertheless, in September we had the embarrassment of a new FDA website to educate the public on good and bad DTC drug ads being built for the FDA by an industry-connected firm with the beguiling misnomer, EthicAd, that boasted it took no money from the drug industry.
When the Center for Science in the Public Interest unearthed the firm's drug industry connections and demanded that Congress investigate the FDA deal, it changed its access-restricted website to remove the names and affiliations of its governing committee.
Is it naive to write such things off to doubly naive do-gooders, new to the FDA, being unaware that their innovations have to pass a “smell test”—or, put another way: How pure is pure enough to do business with the government?
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)