August 18, 2023

AGG Food & Drug Newsletter - August 2023

David Blank, Anuj Desai, Laura Dona, Charmaine Mech, Alan Minsk, Kadeja Watts, Lori Wright

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life sciences disciplines.

Industry Insights

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC Promotional Labeling and Advertising
By Alan G. Minsk & Laura S. Dona

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements Guidance for Industry.” This guidance covers DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs (medical devices and OTC human drugs are not included). The agency explained that quantitative efficacy and risk information “refers to information that numerically addresses the likelihood or magnitude of a drug’s efficacy or risks.”

FDA’s Not Dead Yet: The Agency’s OPDP Issues First Untitled Letter for 2023
By Alan G. Minsk & Kadeja A. Watts

Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail, where John Cleese brings a sickly man to the plague cart, which is touring the village for dead people, and the elderly man says, “I’m not dead yet.” This line came to mind when we saw that the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) recently issued its first Untitled Letter/Notice of Violation for unlawful drug promotion in 2023. This letter reminds industry that OPDP is not dead yet; it will continue to issue letters and require corrective action when it believes a drug promotion is unlawful.

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence
By Lori L. Wright & Laura S. Dona

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that work with AI or are AI-enabled and acknowledges that both the agency and industry need help navigating how FDA-regulated products engage with AI. Further, these pieces provide insight into FDA’s current thinking on this technology. FDA issued the draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions,” in April 2023, with comments to be submitted by July 3, 2023. FDA also published the discussion paper, “Artificial Intelligence in Drug Manufacturing,” in May 2023, following comments from the public.

Prove It All Night (And All Day): FTC Reiterates That Companies Must Have Substantiation for Product Claims or Pay the Price
By Anuj Desai & Alan G. Minsk

In 1978, Bruce Springsteen sang “Prove It All Night.” Forty-five years later (on April 13, 2023), the Federal Trade Commission (“FTC”), a different Boss, reminded approximately 670 over-the-counter drug, homeopathic product, dietary supplement, and functional food companies of its obligations relating to product claim substantiation when it sent out Notices of Pending Offenses.

You Can Apply if You Want To: FDA’s Guidance Concerning Its Refuse to Accept Policy for Cyber Devices
By Alan G. Minsk & Kadeja A. Watts

Channeling Men Without Hats’ 1982 catchy (not classic) hit, “Safety Dance,” FDA told industry in a recently issued guidance that medical device companies could submit marketing applications for cyber devices if they want to (and let the FDA review dance commence), and everything will (likely) work out right. Specifically, on March 30, 2023, FDA released the guidance document, “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act [Federal Food, Drug, and Cosmetic Act],” stating it would not issue a “Refuse to Accept” (“RTA”) decision for marketing applications for cyber medical devices submitted before October 1, 2023, based only on information required by the new statutory provision (Section 524B).

Can We Still Be Friends? FDA Issues Draft Guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Relating to OTC Monograph Drugs
By Alan G. Minsk & Laura S. Dona

Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act [“FDC Act”].” Section 505G and the guidance apply to over-the-counter (“OTC”) drugs that are sold according to an applicable “monograph” and do not require an approved marketing application.

Breathe In, Breathe Out: FDA Tells a Medical Device Company It Needs Its OK to Say That First
By Alan G. Minsk & Kadeja A. Watts

In 1994, the rock band Bush sang, “breathe in, breathe out,” in one of its biggest hits, “Machinehead.” In 2023, a medical device company tried to promote its 510(k)-cleared treatment hood/hyperbaric chamber device for non-invasive ventilation, acute respiratory distress syndrome, and other respiratory-related uses. In a Warning Letter, the Food and Drug Administration told the company that such claims were outside the scope of its 510(k) clearance and, therefore, it was promoting the product unlawfully. The device is intended to “provide the use any place that a clinician would normally use a mask for medical purposes of supplying gas/oxygen/air.”

Medical Device Company Falls and Can’t Get Up: FDA Issues Warning Letter to Femoral Hip Manufacturer for Unlawful Promotion
By Alan G. Minsk & Laura S. Dona

Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical device company that manufactured and distributed a Femoral Resurfacing Cup and Total Hip System. Among other allegations, FDA noted the company promoted the products outside of its 510(k)-cleared uses.

Medical Device Company Hurts Itself and FDA Focuses on the Pain
By Alan G. Minsk & Laura S. Dona

Recently, a medical device company received a Warning Letter from FDA for a number of quality-related deficiencies, including issues with Medical Device Reporting (“MDR”), the promptness (or lack thereof) of handling and closing a Corrective and Preventive Action (“CAPA”), and an inadequate Health Hazard Analysis (“HHA”). Channeling Nine Inch Nails’ 1994 classic song, “Hurt,” the company hurt itself in numerous ways, and FDA focused on the pain that patients might endure because of the quality concerns.

Don’t Bring Me Down: HIV Prescription Drug Company Decides Not to Participate in the NAD Process (And NAD Refers the Matter to FDA and FTC)
By Anuj Desai & Alan G. Minsk

It’s not clear whether the prescription drug company was channeling Electric Light Orchestra’s 1979 hit or The Animals’ 1966 song, but “Don’t Bring Me Down” was the attitude when the company declined to participate in a case before the National Advertising Division (NAD), of BBB National Programs. Specifically, ViiV Healthcare, manufacturer of a single-tablet HIV treatment medication, decided not to respond to a competitor challenge from Gilead Sciences before NAD related to ViiV’s comparative advertising. NAD referred the matter to FDA and the Federal Trade Commission (“FTC”) for review.

The Sun Will Come Up Tomorrow for Another Company: An Interesting Orphan Drug Exclusivity Decision
By Alan G. Minsk & Laura S. Dona

Last month, the Food and Drug Administration’s Office of Orphan Products Development (“OOPD”) found that one prescription drug company was able to, essentially, breach another’s orphan drug exclusivity (and have its new drug application approved) and obtain its own orphan drug exclusivity. FDA’s interpretation and exclusivity of the orphan drug rules continues to evolve.

OIG Greenlights Manufacturer’s Limited Free Drug Program
By David M. Blank & Charmaine A. Mech

On February 28, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 23-02 (“Opinion”), which favorably addresses a pharmaceutical manufacturer’s proposal to offer a free limited supply of medication for patients experiencing insurance coverage delays.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.