HPM Calls On FDA to Post on the Internet All Court Filings Regarding Enforcement Actions

March 11, 2011

On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning their regulatory compliance and enforcement activities accessible, downloadable, and searchable online.”

On March 11, 2011, this firm sent a letter to the FDA Chief Counsel, Ralph S. Tyler, calling on FDA to commit to posting on its website information regarding its enforcement activities, including:

  • the names and judicial districts of all lawsuits filed by the government with regard to activity regulated by FDA;
  • the names and judicial district of all lawsuits filed against the FDA (and/or its officials) in connection with FDA’s regulatory or enforcement activities; and
  • all briefs and other pleadings publicly filed in such cases.

Although some agencies already post online much of this type of information, FDA’s website has not provided a comprehensive picture of the agency’s activities in court. We believe that making all public information available online will promote consistency in FDA actions, and permit industry and the general public to make informed decisions about FDA-regulated products. Whether FDA will agree – or respond – remains to be seen.