Sunlight Foundation

FDA hearing to highlight secret clinical trial data

By Nancy Watzman Oct 28 2009 3:26 p.m.

Next week the Food and Drug Administration's (FDA) transparency taskforce will be holding a hearing asking for people to comment on the issue at the core of the multi-media investigation we released today, "Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret":

The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (emph. added) (3) communication of agency decisions about pending product applications.

We've also gotten a sneak preview of comments that Consumers Union will be filing. Here's a key excerpt:

We urge the FDA to require the public posting of all trial results of applications that are abandoned or not completed within the estimated time period provided in the original clinical trial registration (Public Health Service Act section 402(j)(2)(A)(ii)(I)(jj)).

Section 402(j)(3)(D)(II) of the Public Health Service Act, as added by FDAAA (PL 110-85), should clearly require that unapproved drug and device trial information be made public.  The FDA should move beyond the issue of unapproved applications to ensure that abandoned research data is also reported.

The arguments are overwhelming for advancing science through the public sharing of all clinical trial research results - regardless of whether that trial resulted in an application for FDA approval or amendment or whether the application was unsuccessful.

We will be following up to see who testifies at the hearing and what positions they take.

Search the Blog

Real Time Ticker

Recent Posts

Reporting we're watching

Popular tags

2012 election 2012 elections 2013 Inauguration Ad Ad Hawk Ad Hoc AIG american crossroads Arab Spring Barack Obama BP budget Campaign contributions Campaign Finance Center for Responsive Politics Citizens United consumer banking Contracting Conventions2012 Correspondence crossroads GPS dark money Data Mine datamine debt ceiling Disclose act Distributed Research Dodd-Frank Earmarks Election 2012 Elizabeth Warren FARA FCC FDA FEC Federal Election Commission Finance Data Catalog Financial Bailout Financial Reform FLIT FOIA follow the unlimited money Foreign lobbying Foreign Lobbying Influence Tracker freshmen Fundraising Guns Handy Tools health care Hoc House House Freshmen 112th House Majority PAC Immigration Independent Expenditure Independent expenditures influence Influence Explorer investment James Bopp Jr. Lobbying lobbying tracker Logs_6553 Majority PAC Mark Sanford Market Meltdown Media Medicare meeting logs Mitt Romney National Rifle Association Newt Gingrich NRA obama OGD Open Government Directive Orrin Hatch outside spending Party Time PMA Group political ad sleuth Political Party Time Politwoops President Obama Priorities USA Action Recovery Recovery.gov Rep. John Murtha Research Restore Our Future revolving door Rick Perry Rick Santorum Romney Ron Paul Sen. Christopher Dodd Senate Sheldon Adelson states of transparency Stealthy Wealthy stimulus Sunlight Live super committee super congress Super PAC super PAC profile Super PACs supercommittee Supercongress supreme court TARP Taxpayers for Common Sense transparency