Task Force Asks FDA to Release More Information

The Federal Food and Drug Administration is considering a big change in their disapproval process. Currently, denials for applications and disproved submissions are not released, unless a drug company makes the information public. Even then, the FDA will not make any comments about why it was disproved. New changes would reveal why the drug or device was disproved. The agency has gotten a reputation for being too secretive and hiding valuable information from the public. A transparency task force is asking the FDA to publicize information about what foods, drugs and devices are submitted to the agency for approval. The task force is led by FDA executives.

The task force is also asking the FDA to release inspection reports. The current practice by the FDA is only to release reports that are of a great interest to the public, like the Johnson and Johnson fiasco. 21 different proposals were included in the task forces list of recommendations. The public will get 60 days to voice their opinions about all the recommendations but some will not be up to the public to decide. Some recommendations need legislative action before they can be amended.

One recommendation that could mean big opportunities for a drug company is making withdrawn applications public. In some cases, funding becomes an issue and a company voluntarily withdraws from the approval process. Another company may be able to further the application process and potentially buy the rights to a floundering drug. If approved, some of these recommendations could be implemented by the end of this year.