The Food and Drug Administration (FDA) regulates the pharmaceutical industry two main ways: through guidances and regulations.  Federal regulations are much stronger than guidances; if you don’t obey them, you’ve broken a law. On the other hand, guidances aren’t laws, but tell the industry what the FDA expects and provide advice on how to meet FDA expectations and regulations. Though they don’t have the legal weight of regulations, a recent court case in Florida questions if, in some cases, the FDA may try to use guidances as such.


According to an article referenced in this blog, the ruling of United States of America v. Franck’s Lab (currently being appealed) may give grounds for the industry to argue back against the FDA if it tries to use guidances like regulations. Guidances are meant to explain regulations–not replace them. Some people feel that in cases like Franck’s Lab, the FDA is trying to use the guidances as more than they are.

In United States of America v. Franck’s Lab, the FDA wanted to rely on guidances to boost its authority over the matter of compounding bulk substances in pharmacies. However, as the court ruling pointed out, the “non-binding guidance” (p. 19) didn’t give it that power. Guidances, though, can be published faster thanks to a shorter creation process (as compared to that of rules), and the FDA and the Department of Health and Human Services feel this is valuable to their efforts to address industry questions and problems in less time. As raised by the Franck’s Lab case, however, in its efforts for efficiency, is the FDA blurring the distinction between guidances and regulations?


Should FDA guidances be able to be used with the legal weight of industry regulations?


Guidances can be used with legal weight of regulations if they go through all steps of the regulation creation process.


There are several steps to making regulations, including public discussion via comments on the new rule. In rule making, discussion allows concerned parties to raise questions to which the FDA needs to provide answers. While commenting is part of the guidance-making process, especially for Level 1 guidances, the FDA withholds the right to decide if public discussion is necessary. For Level 2 guidances, comments are not required at all before appearing on the web for use. This article cites examples of when guidances have been released without the FDA responding to comments and points out that the process for making guidances is less thorough than making rules—particularly that guidances don’t require the same amount of public discussion that regulations do.

In one such example, United States of America v. Franck’s Lab, the court notes that the FDA was not only trying to use a guidance as an enforcement document, but was referring to a guidance that hadn’t been publically commented on (p.31). Furthermore, the FDA skipped another step in the rule-making process when it didn’t provide notice of the guidance in the Federal Register, since it felt the updates to the guidance weren’t significant enough to require it (p.30-31). The court stated that public discussion and notice are important to giving a regulation legal weight (p. 72-73).  Because FDA guidances are not accountable to the complete process for making rules, they should not be used as regulations.

The circumvention of commenting is further seen in how the FDA wants to change policies about Laboratory-Developed Tests with guidances, not rule making. In this case, policy is being changed extensively enough to require rule making; that is, the bigger the changes, the more steps needed to give them legal weight. Essentially, the thorough rule-making process is what gives regulations the force of law; because guidances can omit discussion—one of the rule-making steps—they are not entitled to that authority.


The FDA does not have to fulfill the public comment step for making guidances, nor does it do so optionally, so it does not go through all of the process for making regulations. Therefore, FDA guidances should not be used with the legal power of regulations.

For more information on this issue, contact the Kulkarni Law Firm.