The White House has just cleared three pharmaceutical-focused guidance documents that the FDA sent it for review last week – an unusually rapid review that indicates the imminent release of the guidance documents.
- The Office of Information and Regulatory Affairs (OIRA) is a subdivision of the White House’s Office of Management and Budget (OMB) and acts as a sort of regulator of regulators. It is charged with reviewing all major regulatory actions prior to their release by an agency, often to ensure that they are consistent with the President’s vision and preferences of the Executive Branch of the U.S. government.
- In recent years, the FDA has begun to send certain guidance documents to OIRA for review – typically those documents that would have a significant economic impact on a particular sector or require the implementation of specific systems (such as those to facilitate the collection of electronic information).
- In practice, OIRA’s reviews typically take between a few weeks and a few months to complete. Key variables typically include the complexity and length of the document, the type of action (regulations take longer than guidance to review), and any controversial aspects associated with the regulatory action (most often social or economic effects). Very often, OIRA’s final review will result in relatively minor changes to the final document (“consistent with change”), and FDA generally publishes the document within 1-2 weeks after receiving OMB’s permission.
A trio of new guidance documents
- On May 4, FDA sent three documents over to OIRA for its review.
- The first is a guidance document on “ Safety considerations for container labels and carton labeling design to minimize medication errors.” The document would be a final version of a guidance that came out in April 2013 in draft form. The 26-page draft guidance talks about requirements for drug labels, including that they be “legible, readable and easy to understand,” and that good design can reduce the risk of medication errors and clarify critical safety information. Based on the length of time the guidance was under review, it’s not clear if the guidance will be substantially revised compared to prior versions. The guidance did receive a substantial number of industry comments (27), most of which offered advice on specific labeling recommendations in the guidance. In one illustrative comment, someone asked the FDA to pay close attention to date conventions (JUN022013 could be confused with June 22, for example) and label strengths (“should not be reported with ending zeroes after a decimal point). Many other comments asked for FDA to clarify certain terms, such as “adequate white space.”
- The second is a guidance document on the FDA’s regulation on the importation of prescription drugs. The guidance (technically a compliance guide) is specifically focused on the impact of the rule on small entities and is set up as a Q&A document. This document hasn’t been released before by the FDA, so it’s unclear what its exact focus will be. Industry trade groups, notably including PhRMA, are currently suing the FDA over the legality of the final rule. However, FDA recently met with states regarding their implementation of the final rule.
- Finally, FDA is sending a draft guidance document to OIRA on “Risk Management Plans to Mitigate the Potential for Drug Shortages.” This seems related to authority the FDA received under the CARES Act of 2020, which included a provision directing FDA to require each drug manufacturer and Active Pharmaceutical Ingredient (API) manufacturer to “develop, maintain and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which the drug or API of the drug is manufactured.” An FDA webpage on the CARES Act, last updated on May 5 2022, indicates that “FDA plans to issue guidance on risk management plans,” which appears to be this draft guidance. Based on the language of the notice, which says that it is also a “proposed collection” of information, this guidance is likely to call for the submission of such plans.
Now those three guidance documents are poised for immediate release by the FDA.
- On May 11th, OIRA updated its website to indicate that it had concluded its review of the three guidance documents, with actions that were “consistent without change.” The designation means that OIRA did not make any changes to the FDA’s documents, which perhaps led to the unusually rapid review time of one week.
- Because there was no change made to the guidances, the FDA is likely able to publish them very quickly – even within the next few days, if it is so inclined. However, in practice the agency will sometimes delay the publication of documents to allow for coordination between the release of the documents and other public information, either by FDA or the White House. As a hypothetical example, it’s possible the drug importation guidance could be held to ensure its provisions parallel other Executive Branch actions related to drug pricing, which would delay its release.
To contact the author of this analysis, please contact Alec Gaffney ( [email protected])
Key Documents and Dates
- Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide
- Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Guidance for Industry
- Risk Management Plans To Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request