Can the FDA Go Public with Proprietary Information?

Posted by cdavenport on Friday May 21, 2010 Under Drug Safety, FDA

On 19 May 2010, a FDA task force proposed 21 ways that the Agency could release more information to the public in areas like drug evaluation, including information about safety problems with the drugs and devices it rejects.  Although the FDA has long operated under strict confidentiality rules with respect to submitted proprietary information from food, drug, and device companies, this policy has been criticized in recent years.  Critics have charged that the Agency is too slow to disclose drug safety issues (e.g., the links between the popular pain killer Vioxx with heart attack and stroke).  Advocates claim that greater transparency would benefit both consumers and companies, who will be able to learn from the success and failures of competitors.  Approximately half of the new suggestions are designed to give more information about experimental drugs and devices under review at the Agency.  Under current FDA regulations, communication about such products is extremely limited.  The Pharmaceutical Research and Manufacturers Association generally supports increased transparency by the Agency, but industry want to ensure that the competitive development process and intellectual property protections remain intact.  Other items under proposal are discussed.  Comments on the recommendations are being solicited by the FDA task force until July 20, 2010 before the final list of changes for implementation will be submitted to Commissioner Hamburg for consideration.  Note that not all proposals will necessarily be implemented.

Source text:  Drug Discovery & Development – May 21, 2010);  Product Applications (including Investigational Applications) – FDA updated on May 20, 2010.

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