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FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

OPDP issued the following letter on FDA’s website in late December 2017:

  • Untitled Letter to University of California Los Angeles (UCLA) re: Gallium 68 (68GaPSMA) (Dec. 28, 2017) (“68Ga-PSMA Untitled Letter”)

Although issued in December, this letter was not posted on FDA’s website until mid-January, after publication of our monthly alert for December. This was the fifth and final enforcement letter OPDP issued in 2017. Neither OPDP, nor FDA’s Center for Devices and Radiological Health (CDRH) Office of Compliance (OC) or FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ), posted any enforcement letters relating to advertising and promotion on FDA’s website in January.

Office of Prescription Drug Promotion (OPDP)

68Ga-PSMA Untitled Letter (December 2017)

OPDP states that UCLA’s webpage (http://urology.ucla.edu/psma-pet-imaging) and a brochure available through the webpage (titled “New imaging test accurately detects prostate-cancer cells throughout the body”) misbrand the investigational drug 68Ga-PSMA under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA).

Misbranding of an Investigational Drug:

OPDP alleges that the webpage and online brochure misbrand 68Ga-PSMA under FDCA section 502(f)(1) by suggesting in a promotional context that the drug is safe and effective for the purpose for which it is being investigated, i.e., use in PET scans to detect prostate-cancer cells throughout the body, and by otherwise promoting the drug. Under section 502(f)(1) a drug is misbranded unless its labeling bears “adequate directions for use,” but an investigational drug is exempt from such requirement if it “complies with section 505(i) [of the FDCA] . . . and regulations thereunder.” 21 CFR 201.115(b). Among these regulations, “[a] sponsor or investigator . . . shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.” 21 CFR 312.7(a). OPDP alleges that the webpage and brochure fail to comply with the requirements for this exemption from FDCA section 502(f)(1) by making claims that promote 68Ga-PSMA as safe and effective for the purpose for which it is being investigated or that otherwise promote the drug when 68Ga-PSMA has not been approved by FDA for any use. These claims include the following:

  • “New imaging test accurately detects prostate-cancer cells throughout the body”
  • “68Ga-PSMA PET/CT imaging, or PSMA-PET imaging for short, represents a major advance in detecting prostate cancer. At UCLA, with the availability of PSMA-PET imaging patients now have a new option of detecting prostate cancer cells anywhere in the body more accurately than traditional methods.”
  • “Since PSMA-PET imaging became available at UCLA in September, patients now have a new option that’s better at detecting the location of prostate-cancer recurrences.”
  • “This test has had a tremendous and immediate impact on prostate-cancer patients . . .. They can really benefit from this.”
  • “There are no common side effects or significant risks . . .”“In contrast to the traditional studies, PSMA-PET imaging offers high sensitivity and specificity.”
  • “Whereas the unreliable results of traditional tests can lead to unnecessary or insufficient disease treatment and management decisions, PSMA-PET allows doctors to make more informed treatment decisions. While radiation and surgery are typical in localized cases, chemotherapy or hormone therapy might be appropriate in cases where PSMA-PET imaging detects prostate-cancer cells in the bone or lymph nodes. PSMA-PET imaging allows for more informed care, with likely better outcomes as a result.”
  • “Ga-PSMA PET CT is now offered at UCLA and aims to improve management of recurrent and high-risk cancers.”

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

© 2019 Covington & Burling LLP

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About this Author

Scott Cunningham, Food and drug attorney, Covington Burling
Partner

Scott Cunningham is a member of the firm’s Food and Drug practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and...

202-662-5275
Stefanie Doebler, Food and drug attorney, Covington Burling
Of Counsel

Stefanie Doebler is of counsel in the firm's health care and food and drug practice groups.  Her practice focuses on health care compliance matters for pharmaceutical and medical device clients.  She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

202.662.5271
Michael Labson, Life sciences lawyer, Covington
Partner

Michael Labson provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area, and works actively on corporate transactions and government investigations.

Mr. Labson’s recent work has involved issues such as clinical trial misconduct; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; biosimilars; product promotion and scientific exchange; REMS; pharmacovigilance; Rx/OTC switches; and DEA regulation of controlled...

202-662-5220
Amy Leiser, Washington DC, Covington Law Firm, food and drug attorney
Associate

Amy Leiser is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device group. She advises pharmaceutical, biotechnology and device companies on a variety of regulatory and compliance issues.

Representative Matters

  • Advised on compliance with ClinicalTrials.gov registration and reporting requirements.
  • Advised on regulatory compliance issues regarding drug listing.
  • Drafted report about FDA’s expedited programs.
  • Conducted international survey regarding regulation of biosimilar...
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