Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update 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 science disciplines.
In This Issue
- Understanding FDA’s Prescription Drug Promotion Priorities
- Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission
- It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product
- In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule
- Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product
- A Change Is Gonna Come: AdvaMed Revises Its Code of Ethics on Interactions With Health Care Professionals
- Lori Wright Featured in INSIGHTful Discussions Publication on Straight Talk on Tech: Implementing IT in Health Care
Industry Insights
Understanding FDA’s Prescription Drug Promotion Priorities
By Alan G. Minsk and Laura S. Dona
In an article published by Law360 on June 6, 2022, Alan G. Minsk and Laura S. Dona provided an in-depth overview of notices of violation and warning letters issued to pharmaceutical companies over the last 18 months by the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”), as well as a look into the “crystal ball” of what we might anticipate from OPDP going forward.
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Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission
By Alan G. Minsk and Kadeja A. Watts
In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft guidance in June titled, “Considerations for Rescinding Therapy Designation,” which explains when it might take away this treasured status.
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It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product
By Alan G. Minsk and Laura S. Dona
“It’s a heartache, nothing but a heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug company for unlawfully promoting its cholesterol-lowering prescription product.
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In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule
By Alan G. Minsk and Kadeja A. Watts
Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity Compliance Guide).” The agency intends that the guidance should help companies comply with its Final Rule on importation of prescription drugs. While we know that any guidance document is not legally binding, it represents FDA’s current thinking on the subject. FDA will accept comments at any time.
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Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product
By Alan G. Minsk and Laura S. Dona
Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch”? Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter to a pharmaceutical company for unlawfully promoting its topical treatment for plaque psoriasis in adults. OPDP found the promotions (a direct-to-consumer (“DTC”) video (shown on a Lifetime TV program initially) and storyboard, and the product’s healthcare professional-directed website) were out of touch with regulatory requirements, particularly regarding the presentation of risk information and overstatement of benefit for the dermatological product.
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A Change Is Gonna Come: AdvaMed Revises Its Code of Ethics on Interactions With Health Care Professionals
By Alan G. Minsk and Charmaine A. Mech
In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s Center for Drug Evaluation and Research issued a Warning Letter to a drug company for improper drug listing information.
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Lori Wright Featured in INSIGHTful Discussions Publication on Straight Talk on Tech: Implementing IT in Health Care
By Lori L. Wright
Lori Wright, AGG partner and chair of the Technology practice, was recently published in INSIGHTful Discussion by the Wilmington Business Journal. She contributed to an article titled “Straight Talk on Tech: Implementing IT in Health Care.” Atromitos, LLC sponsored the publication released in May.
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