The Justice Department has changed its policy and “will no longer rely on (FDA) guidance documents to establish civil law infractions,” says Food Safety News. The change follows a memo last November by Attorney General Jeff Sessions against codes of conduct that are issued by the government but are not the result of the formal rule-making process.
The policy change became effective in late January, meaning that Justice Department litigators cannot present agency ‘guidance’ as being equivalent to a binding rule and that noncompliance cannot be used as proof of a violation, said Food Safety News. Conservative groups contend the FDA has issued hundreds of guidance documents in recent years on topics that used to be the subject of formal regulations.
As an example of agency guidance, the FDA issued Guidance for Industry document No 213 in December 2013 to phase out the use of medically important antibiotics as livestock feed additives to make cattle, hogs and poultry put on weight faster. Like all FDA guidance, the document prominently says it presents the FDA’s “current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”
Megan Grossman of the Philadelphia law firm Segal McCambridge Singer and Mahoney said the new policy will likely reduce the volume of federal actions brought against pharmaceutical companies, her area of expertise. The new policy could have ramifications on civil lawsuits, she wrote in The Legal Intelligencer. “If the government is not permitted to utilize the guidance documents to prove alleged violations against pharmaceutical companies, why should plaintiffs in product liability lawsuits be permitted to do so? Likewise, defendants should continue to expect vigorous opposition to their efforts to offer guidance documents as substantive evidence when appropriate.”