By Dara Katcher Levy –Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most promotional material that trigger DDMAC letters citingunsubstantiated superiority claims, the promotional claims that were the subject of this letter were based on the statistically significant results of the primary endpoints of two comparative studies. In addition to the sections of the Federal Food, Drug, and Cosmetic Act, DDMAC cites violations of regulations at 21 C.F.R. § 202.1(e)(6)(ii), (xviii); (e)(7)(1) and (ii).The Focalin XR detail aid contained the following information, cited by DDMAC:Two well-controlled studies confirmed the efficacy of Focalin XR versus Concerta at 2 hours postdose.

become effective on May 20, 2024 and will require Prescription Drug Firms undertaking DTC to be compliant by November 20, 2024. This means that Prescription Drug Firms will have about one year to ready themselves and modify their ads to align with the updated requirements.Prescription Drug Firms must comply with DTC format regulations for ads.The Rule’s Major Statement format requirements expand existing regulatory safeguards for consumer protection. The FDA aims to enable consumers to make well-informed health care decisions by mitigating the spread of misinformation. As such, Prescription Drug Firms must devise and execute a new strategy in the coming year to adjust their media practices to clearly present side effects and contraindications within their ads. Proposed rule was first published in 75 Fed. Reg. 15376 (March 29, 2010). 88 Fed. Reg. 80958 (Nov. 21, 2023). Prescription drug ads are required to contain a fair balance of risk and benefit information to establish neutrality. 21 C.F.R. §202.1(e)(5)(ii). These standards will be included within 21 C.F.R. §202.1(e)(1).[View source.]

Specifically, the FDA states that information based on “speculation or belief,” as well as information “based on a poorly designed or conducted study or analysis,” would not meet the substantiation standard, but it does not elaborate on data sources that may be inappropriate. In general, the guidance explains that the standard is a flexible one, and it states that “FDA believes that a variety of types and studies and analyses can provide useful additional information about a medical product for its approved/cleared conditions of use” so long as “firms’ product communications [do] not overstate the findings of or the conclusions that can be drawn from such studies or analyses, or fail to disclose their material limitations.”Finally, the consistent with the labeling guidance acknowledges, which the draft guidance did not, the apparent conflict between the “scientifically appropriate and statistically sound” standard it endorses and the regulatory requirement in 21 C.F.R. § 202.1(e)(6) that prescription drug advertising claims be supported by “substantial evidence.” The consistent with the labeling guidance now explicitly states that “evidence other than that which meets the new drug approval standard of ‘substantial evidence’ of effectiveness could be used to support certain representations or suggestions about a prescription drug in a [Consistent with FDA-required labeling (“CFL”)] promotional communication.”

In general, the Guidance explains that the standard is a flexible one, and it states that “FDA believes that a variety of types and studies and analyses can provide useful additional information about a medical product for its approved/cleared conditions of use” so long as “firms’ product communications [do] not overstate the findings of or the conclusions that can be drawn from such studies or analyses, or fail to disclose their material limitations.” Finally, the Consistent with the Labeling Guidance acknowledges, which the draft guidance did not, the apparent conflict between the “scientifically appropriate and statistically sound” standard it endorses and the regulatory requirement in 21 C.F.R. § 202.1(e)(6) that prescription drug advertising claims be supported by “substantial evidence.” The Consistent with the Labeling Guidance now explicitly states that “evidence other than that which meets the new drug approval standard of ‘substantial evidence’ of effectiveness could be used to support certain representations or suggestions about a prescription drug in a [Consistent with FDA-required labeling (“CFL”)] promotional communication.”

These types of ads must include, among other things, what is often called a “major statement,” i.e., information relating to the advertised drug’s “major side effects and contraindications” in either the audio or the audio and visual parts of the ad. 21 CFR 202.1(e)(1). In the Federal Register notice, the agency explained that it is considering a new approach to satisfy this requirement called a “limited risks plus disclosure strategy.”

(Click here to view the opinion.) And a second pharmaceutical company, Pacira Pharmaceuticals, Inc., along with two physicians, adopted Amarin’s playbook and filed suit against FDA in the Southern District of New York, seeking, inter alia, a ruling that FDA’s regulation on prescription drug advertising, 21 C.F.R. § 202.1, violates the First Amendment. When evaluated in the context of DOJ’s decision not to appeal the Caronia decision, the Amarin decision, its procedural history and the subsequent developments — including Pacira’s suit — have profound implications for FDA-regulated companies.

The FDCA does not define advertising, but FDA long ago adopted a regulation giving examples of promotion that would be considered advertising: “Advertisements [subject to the FDCA] . . . include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.” 21 C.F.R. § 202.1(l)(1). (The regulation nominally applies to drugs, but FDA has long considered it applicable to devices as well.

By Carrie S. Martin & Dara Katcher Levy – On March 29, 2010, FDA published a proposed rule to amend its direct-to-consumer (“DTC”) regulations to require that prescription drug advertisements present information about side effects and contraindications in a “clear, conspicuous, and neutral manner.” Current regulations, found in 21 C.F.R. 202.1, require the disclosure of major side effects and contraindications (commonly known as the “major statement”) in either the audio or audio and visual parts of an advertisement and that they be presented in a comparable manner to any statements regarding the drug’s efficacy. With the passage of the FDA Amendments Act of 2007 (“FDAAA”), Section 502(n) of the Food and Drug Cosmetic Act (“FDC Act”) now requires that the major statement in television and radio advertisements to consumers be presented in a “clear, conspicuous, and neutral manner.”

er. The final rule does not affect the content of a major statement; rather, it focuses on the accessibility of that information in consumer-friendly language that is readily understandable.Companies may voluntarily request comments from the FDA and receive feedback on their proposed DTC advertisements before their dissemination.While the effective date of the final rule is set for May 20, 2024, companies are granted until November 20, 2024, to come into compliance with these new requirements.In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC) advertisements for prescription drugs in television and radio formats. One month later in December 2023, FDA issued a final guidance document, which is intended to help entities understand and comply with the standards established in the final rule. These standards will be codified at 21 CFR 202.1(e)(1)(ii)(A)–(E).Executive SummaryThe final rule, implemented as part of the Food and Drug Administration Amendments Act of 2007, establishes five key standards aimed at presenting the “major statement” in a DTC advertisement in a clear, conspicuous and neutral manner. The final rule does not affect the content of a major statement — for example, information regarding the major side effects and counterindications. Rather, it focuses on the consumer accessibility of that information. The final rule establishes that the information in the advertisement must be presented in consumer-friendly language that is readily understandable. The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the advertisement. For advertisements in television format, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration of time to allow it to be read easily. Additi

The rule, which amends 21 C.F.R. 202.1(e), becomes effective on May20, 2024. The compliance date is November 20, 2024.HighlightsStandard #1:The Final Rule requires a company to provide the major statement in consumer-friendly language and terminology that people can understand.Standard #2: The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the ad in terms of volume, articulation, and pacing.Standard #3: In a TV ad, the major statement must be presented concurrently using both audio and text (“dual modality”). Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio, and the text is shown for a sufficient duration to allow it to be read easily.Standard #4: In a TV ad, the major statement must be presented so that a consumer can easily read it — placement on the screen and contrast with the background, as well as size and style of font, mu