On Jan. 25, the associate attorney general of the United States issued a policy that prohibits the Department of Justice (DOJ) civil litigators from using guidance documents to establish violations of law in civil enforcement actions. In other words, the newly issued policy forbids department litigators from using its civil enforcement authority to convert guidance documents issued by governmental agencies into binding rules.
The policy follows a memorandum issued by Attorney General Jeff Sessions on Nov. 16, 2017. In the memorandum, Sessions specifically noted that it came to his attention that “the department has in the past published guidance documents—or similar instruments of future effect by other names, such as letters to regulated entities—that effectively bind private parties without undergoing the rulemaking process.” He explained that when agencies side-step the requirement to use the notice-and-comment rulemaking process set forth in the Administrative Procedure Act, they are not abiding by the required principle that “agencies regulate only within the authority delegated to them by Congress.” For these reasons, AG Sessions declared that the “department [of Justice] will no longer engage in this practice.” He stated that the department will not issue guidance documents that purport to create rights or obligations that bind persons or entities outside of the executive branch. In the memorandum, AG Sessions also set forth numerous principles about which the department shall adhere when issuing guidance documents.
In the Jan. 25 policy, the principles set forth in AG Sessions’ memorandum are further applied to DOJ litigators who utilize guidance documents in affirmative civil enforcement actions. The civil litigators were definitively informed that “guidance documents cannot create binding requirements that do not already exist by statute or regulation” and may not “convert agency guidance documents into binding rules.” Moreover, the DOJ litigators were instructed that they are not permitted to use noncompliance of agency guidance documents as a basis for proving violations in affirmative civil enforcement cases.
This DOJ policy is applicable to the life sciences law practice area because the U.S. Food & Drug Administration (FDA) routinely issues guidance documents for all areas under its control, including food, cosmetics, veterinary products, drugs, medical devices, and vaccines, blood and biologics, among others. The FDA usually publishes a “draft” guidance document about a particular topic and provides a comment period before issuing a “final” guidance document. Prominently displayed on the FDA’s website is the following statement: “Guidance documents represent the agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.”
This statement conforms with the principles set forth in the recent DOJ policy. A similar statement is also included at the beginning of every guidance document issued by the agency.
One of the most recently issued “final” drug guidance documents from the FDA falls under the category of labeling and is titled “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.” Another recent “final” guidance sets forth the FDA’s policy for licensed pharmacists or physicians that compound drug products that are essentially copies of commercially available drugs. Some examples of current “draft” drug guidances available for comment are “Good ANDA Submission Practices” for Generic Drug Manufacturers and “Drug Products Labeled as Homeopathic.” On Jan. 19, the FDA’s Center for Drug Evaluation and Research (CDER) published a Guidance Agenda for the 2018 calendar year. Among the list of guidances that the CDER is expecting to publish are:
- Presenting quantitative information in direct-to-consumer promotional labeling and advertisements
- Updating promotional materials to reflect labeling changes to risk information
- Opioid dependence: developing depot buprenorphine products for treatment
- Meta-analysis of randomized controlled clinical trials to evaluate the safety of human drugs or biologic products
- Instructions for use for human prescription drug and biological products—content and format
The new DOJ policy will likely have an effect on the amount of governmental actions brought against pharmaceutical companies, like qui tam claims under the Federal False Claims Act. Undeniably, DOJ civil litigators have been instructed by their superiors that noncompliance with FDA guidance documents cannot be utilized as a basis for proving violations in affirmative civil enforcement actions against pharmaceutical companies. Moreover, pharmaceutical companies will likely point to the newly issued DOJ policy in defending themselves against governmental actions that have been filed against them.
Of importance, the DOJ policy ends by stating that it applies only to DOJ components and employees and “is not intended to, does not, and may not be relied upon to, create any rights, substantive or procedural, enforceable at law by any party in any matter civil or criminal.” In civil litigation pharmaceutical products liability lawsuits, both plaintiffs and defendants often attempt to utilize FDA guidance documents to either prosecute or establish a defense in their cases. As a practical consideration, 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. Indeed, it remains to be seen if the closing statement of the DOJ policy will have a significant effect on pharmaceutical product liability cases going forward. But it is clear that FDA regulatory experts in these lawsuits will likely be questioned about their understanding of the differences between regulations and guidance documents if their opinions are based upon FDA guidances.
Megan E. Grossman is a shareholder at Segal McCambridge Singer & Mahoney in its Philadelphia office. She is the chair of the firm’s life sciences practice group and she focuses her practice on the defense of pharmaceutical and medical device companies in products liability lawsuits.