As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.
Promotion of Emergency Use Drugs
- Overview of Emergency Use Authorization
Under the Food Drug and Cosmetic Act (the “FDCA”), FDA may authorize unapproved medical products, including drugs, for use in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.[1]
Given the urgent nature of circumstances necessitating EUA, FDA’s review process is significantly abbreviated and, therefore, requirements for obtaining EUA are less burdensome than the requirements for obtaining full FDA approval.[2] Specifically, FDA may grant EUA if (i) the Secretary of Health and Human Services (“HHS”) has declared a state of emergency (e.g., the COVID-19 emergency); (ii) based on the totality of scientific evidence available, FDA has reason to believe that (a) the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent and (b) the known potential benefits of the product outweigh the known potential risks; and (iii) as a matter of fact, there are no adequate, approved, and available alternatives.[3]
FDA’s abbreviated review for EUA, as compared to the review necessary for full FDA approval, means that FDA does not certify that products granted EUA are safe and effective for their intended use, but rather than products granted EUA may be safe and effective for their authorized use.
Because the evidentiary threshold for obtaining EUA is much lower than the evidentiary threshold for obtaining full FDA approval, the Agency places a number of conditions on authorization in order to protect the public from the potential dangers of a medical product that has not been fully evaluated.[4]
- Conditions of Authorization
Conditions of authorization are tailored to the specific product granted EUA and are established in the Letter of Authorization (“LOA”) issued by the Center for Drug Evaluation and Research (“CDER”), a division of FDA. Although each EUA product is given its own specific set of conditions, most LOAs include certain base requirements that apply to all EUA products, such as disclosures to healthcare professionals and patients, as well as monitoring and reporting of adverse events.[5]
Developers of EUA products are typically also limited in the types of promotional claims they are permitted to make about the product. For example, since the beginning of the COVID-19 emergency, CDER has prohibited developers of COVID-19 drugs from representing or suggesting that a COVID-19 drug is “safe” or “effective” for its authorized use in any print, advertising, or promotional materials.[6] The Agency’s reasoning has been that any claims of safety or efficacy might suggest to consumers that the product has satisfied the standard for full FDA approval, which, in part, requires that the product is “safe and effective for its intended use,”[7] and, therefore, the public may be misled to believe that the product is FDA-approved instead of just FDA-authorizedfor use limited to the duration of the emergency.
Additionally, because emergency situations demand a certain degree of flexibility, the FDCA permits CDER to revoke or revise conditions of authorization as an emergent situation develops if such revocation or revision would protect public health and safety.[8] Through the Memorandum, CDER has acted upon this statutory authority by revising the conditions it initially established with respect to print, advertising, and promotional materials for certain COVID-19 drugs granted EUA.
Key Changes
Due to the rapidly evolving nature of COVID-19, it has become increasingly important that both healthcare providers and consumers have access to comprehensive, accurate, and non-misleading information on potential treatment options. Acknowledging the unique COVID-19 landscape and this related need for transparency, CDER, in its Memorandum, has revised its policy to permit developers of specified COVID-19 drugs[9] to make certain claims related to safety or efficacy in print, advertising, or promotional materials.[10]
However, CDER’s policy change with respect to these drugs is limited in scope – safety and efficacy claims made in print, advertising, and promotional materials must be tied to clinical trial data. Specifically, print, advertising, and promotional materials may only describe safety or efficacy results of clinical trials summarized in the drug’s authorized labeling, and such descriptions must include any limitations of clinical trial data described in the drug’s authorized labeling.[11] Despite this slight relaxation of restrictions on drug promotion, the specified drugs are still bound by the rule that applies to all EUAs – in no event may the print, advertising, or promotional materials claim that the drug is “safe and effective” for its authorized use, as this language is deceptively similar to the standard for full FDA approval.[12]
Additionally, the policy change reflected in CDER’s Memorandum requires that print, advertising, and promotional materials for these COVID-19 drugs be submitted to FDA at least fourteen (14) days prior to initial dissemination or first use.[13] During its review of submitted materials, FDA will primarily be assessing whether clinical trial results related to safety and efficacy are accurately described and whether the materials are consistent with the terms and conditions of the drug’s LOA, including the authorized labeling.[14]
Opportunity for Developers of EUA Drugs
It is unsurprising that FDA continues to adjust its policy on the scope of information it feels comfortable permitting in the promotion of EUA drugs, given that: (i) FDA’s EUA program is relatively new as compared to the long-standing program for full FDA approval;[15] (ii) the regulations governing the EUA process leave the responsibility of establishing conditions for the advertising and promotion of EUA drugs up to the Agency;[16] and (iii) FDA is operating on the heels of a public health emergency (i.e., COVID-19) that has changed the healthcare landscape and illuminated the need for quick, accurate, and comprehensive information about emergency therapeutics.
The policy change established in FDA’s Memorandum will permit developers of the specified COVID-19 drugs to more freely promote these products. Although the Memorandum currently only applies to these specified drugs, it offers a valuable glimpse at FDA’s current thinking with respect to the promotion of EUA drugs and, specifically, the scope of information FDA is willing to allow in such promotion. To be sure, aside from avoiding conclusions about safety and efficacy and strictly sticking to the approved EUA labeling, FDA’s approach on what is permissible to promote does not diverge to a large degree from how FDA treats fully approved drugs.
Nevertheless, the shift in FDA’s approach to the promotion of these specified drugs could be extended to apply to other EUA drugs and would be especially beneficial for other drug developers pursuing candidate products in the space. Developers of COVID-19 drugs with EUA, especially those not covered by the Memorandum, should continue to monitor FDA guidance with respect to EUA conditions, as the Agency has stated that it “will continue to assess the circumstances and appropriateness of each EUA covering an authorized COVID-19 therapeutic and will make additional revisions, when appropriate.”[17]
FOOTNOTES
[1] See 21 U.S.C. § 360bbb-3(a).
[2] SeeMemorandum - Summary Basis for Revising Certain Conditions on Printed, Advertising and Promotional Materials, FDA, p. 2 (Oct. 27, 2022).
[3] See 21 U.S.C. § 360bbb-3(c).
[4] See Memorandum at p. 2.
[5] See Memorandum at p. 1.
[6] See Memorandum at p. 2.
[7] See 21 U.S.C. § 355(d).
[8] FDCA § 564(g)(2)(C)
[9] The policy change reflected in the Memorandum applies only to the six (6) COVID-19 therapies specified therein.
[10] See Memorandum at pp. 2-3.
[11] See Memorandum at p. 3.
[12] See id.
[13] See id.
[14] See id.
[15] FDA’s EUA program was established in 2004. (See Pub. L. 108-276, §4(a), July 21, 2004, 118 Stat. 853).
[16] See 21 U.S.C. § 360bbb-3(e)(4) (“The Secretary may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a product for which an authorization under this section is issued…”).
[17] See Memorandum at p. 5.