Food and drug agency to study greater openness

Food and drug agency to study greater openness:

"WASHINGTON -The government's food and drug regulators want to open their files to the public.

Well, maybe not all of their files. And not right away.

Food and Drug Administration Commissioner Margaret Hamburg announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months.

The FDA has long operated under strict confidentiality rules. Its scientists routinely handle reams of private information from drug companies, medical device manufacturers, even laboratories working on genetically engineered animals. The clinical data is critical for government experts to make decisions about the safety and effectiveness of products that could be sold to the public. But improper
disclosure — for example, to a competitor — can severely damage a company laboring to bring a new product to market.

Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA's credibility within the medical community and among consumers."