FDA wants to be more transparent – what does that mean to the industry?

Recent article in the USA Today, June 3rd, the FDA is asking for help to become more transparent. The FDA is planning to set up task force public meetings to get recommendations on how to make the agency more transparent.

What does this mean to the industry? The FDA has stated that one of the topics for the debate has been how the agency can balance manufacturer’s proprietary concerns with the public’s desire to know about clinical trial results for drugs not approved. Some critics of the FDA have stated that the FDA is like a black box, that makes decision without explaining them. The FDA commissioner stated that the agency can and should communicate with the public in a way that provides more clarity about the agency and its processes, not less.

The first of these public meetings will be in Washington DC on June 24, and the FDA has listed the following questions that they would like to pursue at the meeting:

• How can the agency better explain what it does?
• What should the FDA reveal about enforcement actions, product approvals and recalls?
• What tools should the agency use to provide more useful information?
• What, if any, legislative or regulatory changes are needed to make the FDA more transparent?
• What information should remain confidential?

The industry should make their concerns know. The FDA critic Sidney Wolfe, acting president of Public Citizen and director of the Health Research Group, stated that this move to more transparency is long time coming.

There is some move to change the FDA’s long-standing practice of keeping data from pre-market clinical trials confidential and to amend the Federal FD&C Act to say that safety and effectiveness data are not trade secrets that must be confidential.

What is the damage to the industry if this information is made available not only to the public but to your competitors?

For more information on this article, please email mdi at info@mdiconsultants.com and reference transparency.