Who is watching the watchers? FDA New Announcement

The FDA made ground-breaking news as the US government agency created new rules for its own rulings.

Who is the FDA and why are they so important?

We'll go directly to the source, the FDA and give you their own definition:

"FDA advisory committees are panels of independent, outside experts -- often the world’s leading authorities in their fields -- who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. Last year FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children."

Many of these changes will go into effect immediately, with all of them to be implemented within the next 120 days.

So what are the changes?

1.	Essentially, there are stricter guidelines on financial connections to board members who may have a conflict of interest. These have been quantified to $50,000 for the voting member or a family member.
2.	Another critical aspect is transparency. They will now be posting briefing materials at least 48 hours prior to voting on the FDA website. These briefings are an impertive aspect in the voting process because they are often the foundation of the decision. Any posted material will become a permanent record of the meeting.
3.	They also proposed a new way of voting- simulataneously. Why? There would be no undue influence made by previous votes.
4.	A more formal process of when to refer a matter to an advisory committee. There currently is no formal process, and therefore, no predictability or transparency.

You can read more about the changes as well as review the documents on the FDA's website:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html