As I see itThe Democratic Congressional majority's “first 100 hours” of unilateral legislative action before it goes bipartisan includes only one drug item—giving the government price negotiating authority for Medicare drugs. After that, a whole range of industry issues will be on a more flexible agenda. These include pressure to reign in DTC ads, especially in the first years of a drug's launch; funding to expand the FDA's oversight over marketing practices; more FDA resources and authority to monitor safety; and closer surveillance of human subject protection in clinical studies.
An important driving force in these activities will be the Democrats' need to show political effectiveness ahead of the 2008 elections. This will squeeze agencies like the FDA, which will be trying harder than ever not to be caught in volatile clashes.
An early sign of the new atmosphere might be seen in the prediction from the conservative Manhattan Institute's Paul Howard that the untimely demise of Pfizer's torcetrapib will mute Congressional plans to institute onerous new safety regulations when the PDUFA is reauthorized.
Thanks to Pfizer's woes, he wrote, Congress has a bird's-eye view of how difficult and expensive it is to develop new medicines, and why better science is what is really in the public's best interest.
While skirmishing on Medicare drug pricing will be vigorous during the first 100 legislative hours, for the remainder of the 110th Congress, expect less heat as the Democrats pick their way warily through the Administration's vulnerabilities.
Among these is the Bush penchant for secrecy, which House Government Reform chairman Henry Waxman (D-CA) has targeted for special attention by a newly created subcommittee. The FDA has a dismal record in responding to Freedom of Information Act requests.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)