Regulatory Roundup: FDA Issues Strategic Plan for Risk Communication; More...

October 8, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting...

The US Food and Drug Administration will partner with the US Department of Agriculture (USDA) to develop new food safety rules. The two authorities will work with farmers, industry, and stakeholders to create best practices and new safety regulations for fresh produce.

FDA’s Transparency Task Force will hold its second public meeting on Nov. 3, 2009, seeking comments on how to ensure that information on FDA activities and decision-making is useful, understandable, and accessible to the public. The Task Force is looking for comments on three specific issues: early communication about emerging safety issues concerning FDA-regulated products, disclosure of information about product applications that are abandoned, and communication of agency decisions about pending product applications. Those interested in attending the meeting must register by Oct. 27, 2009. Electronic or written comments may be submitted by Nov. 6, 2009, at www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

FDA outlined its efforts to disseminate more meaningful public health information in its Strategic Plan for Risk Communication. The plan lays out a framework for FDA to provide information about FDA-regulated products to healthcare professionals, patients, and consumers, and for how the agency oversees industry communications. FDA identified more than 70 specific actions to take over the next five years, including 14 that the agency commits to accomplishing during the next year. Some of those actions include designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products; producing a research agenda for public dissemination; and creating a library of multimedia communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes.

The European Commission (EC) has been conducting surprise inspections at pharmaceutical companies, and the agency will be looking specifically for signs of anticompetitive behavior, according to a statement released by the EC. "The EC has reason to believe that the provisions of the EC Treaty prohibiting restrictive business practices and/or abuse of a dominant market position (Articles 81 and 82) may have been infringed," the statement said. In January 2008, it launched a sector inquiry after a significant decline in FDA drug approvals; in particular there was concern that large pharma companies were blocking market entry of generic products. This fear was confirmed in a final report released in July 2009. In response, the EC said it would intensify its scrutiny of the pharma sector and monitor settlements between originator and generic drug companies.The latest inspections, which were conducted on Oct. 6, 2009, are the first step in the investigations, and the EC has stressed that such inspections do "not mean that the companies are guilty."