The Food and Drug Administration (FDA) recently released guidance for generic pharmaceutical manufacturers, which recommends that generic medications have a similar appearance to the reference drug (the brand name drug of which the generic is a version). The FDA believes this practice will help decrease medication errors and increase adherence.
The Network was asked whether this guidance is legally binding, and if not, whether the FDA could make a rule on the matter, or if making the guidance legally binding would require legislation.
The guidance from the FDA has no legally binding effect. In fact, the following language is contained in the guidance document:
This guidance represents the current thinking of the [FDA] on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
While the guidance is not binding, there is a process for drafting and releasing the guidance, and public participation in that process. For example, the public can suggest areas for guidance document development, provide input on guidance documents FDA is developing, or suggest that FDA revise or withdraw an existing guidance document. There are also periods of public comment for any guidance documents in progress.
The process allows the public to help shape the FDA’s “current thinking on a topic.” Full details on the process can be found under Code of Federal Regulations Title 21.
In order for something that the FDA releases to become binding, there would have to be legislation or a rule created. In order for an agency to make these rules, it must follow the Administrative Procedures Act – an easy-to-read guide to the rulemaking process is published by the Office of the Federal Register.
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