Clinical Trial Data Secrecy Act

Congress, Federal Bureaucracy Block Patient Access

Boy! I didn't have to look far to find another egregious example of How Corporatism Works.

In 2007 the Senate debated a bill called the Medical Device User Fee Amendments Act. That law, if it had been enacted, would have required companies to report the results of their clinical trials when they were finished, provided that the drugs or devices received FDA approval.

At the same time, a House bill, H.R. 2900, required that the clinical trial results must be made available to the public whether or not the drug or device being tested had been approved by the FDA.

Medical device and drug manufacturers far preferred the Senate version, arguing that publishing information about products that had not received approval could hurt their bottom line.

Both Legislative bodies passed their versions of the bills and they went to the conference committee. The Bill that emerged from the Committee, 422 pages, was available for members to read for only one hour before debate. On September 9, 2007, the House voted 405 to 7 to approve the new law, and the Senate followed suit the next day, passing it by unanimous consent.

The House language, which would have required that results data for unapproved products be made available, was gone.

No problem. The National Institute of Health was authorized under the law to issue regulations. However, as is indicated by the attached list of comments to the proposed legislation at Regulations Dot Gov, lobbyists descended and killed disclosure. Not even patients can find out the data now.

Below is a video with one of the patients impacted by the federal corporatism policy related to medical devices, Bray Patrick-Lake.

The Heart of the Matter from Sunlight Foundation on Vimeo.

Information about this post was found at The Sunlight Foundation.