PharmExec Blog

Looking Into the Future: FDA’s 2011 Guidance Agenda

On December 7, FDA released its annual guidance agenda, which serves as a blueprint—almost a wish list— for what the organization plans to focus its time and resources on in the coming year.

FDA’s good guidance practices regulations [GGP] require it to publish for public comment an annual summary of key priorities in the coming calendar year.  The document is intended to ensure involvement of interest groups and the public in how the agency performs its mission and spends its budget.

The following list contains what the Agency and Commissioner hope to spend most of their time on in 2011:


• Standards for making comparative claims in prescription drug promotion

• DTC television advertisements—FDA Amendments Act of 2007 DTC Television Pre-Review Program, with particular emphasis on how the Agency intends to address the issue of certifying the legality and safety of content for TV ads going forward.  FDA has been harshly criticized by consumer groups for acting with ambivalence in this key area of drug promotion.

• Promotion of prescription drug products using social media tools. This includes creating clear guidelines in setting legal boundaries between what may constitute a simple exchange of information and commercially oriented promotion.


• defining oncology endpoints in clinical trials for non-small cell lung cancer

• General clinical pharmacology consideration for pediatric studies for drugs and biological products


• standards for superiority in adaptive trial designs

Combination Products:

• building a clear regulatory pathway for incorporating drug diagnostics in co-development programs with small molecules and biologics.

Current Good Manufacturing Practices Compliance:

• Importation of active pharmaceutical ingredients for use in human drugs, standards to enhance safety and efficacy in international trade.

Drug Safety Information:

• Best practices for conducting pharmacovigilance studies using electronic healthcare data

The list should not be seen as exhaustive or definitive—given the Agency’s vast remit, priorities can shift or be overtaken by events. In that regard, the list includes enough new initiatives in areas outside the remit of pharmaceutical regulation—such as food safety—to suggest FDA resources will continue to be stretched to the limit next year. This guidance will also need to pass muster with the new GOP majority in the House of Representatives, which is likely to tone down any hint of regulatory activism in the Agency as it moves forward.

For the complete agenda, please visit the Federal Register website entry for December 7, 2010.

There is no deadline on when to submit public comment, which can be done by clicking here.

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