15 December 2023
Public Citizen Petitions FDA to Strengthen Warnings and Remove Misleading Statements
The U.S. advocacy group Public Citizen has set its sights on AbbVie’s popular medical and cosmetic injection, Botox, as well as its competitors. In a petition to the FDA, Public Citizen has called for stronger safety warnings and the removal of misleading promotional statements from the labeling of Botox and similar drugs. The group argues that there are serious safety risks associated with these neurotoxin-based injections and that current warnings do not adequately address these concerns. This move could potentially impact the multi-billion dollar medical aesthetics industry and reshape the way these products are marketed and regulated.
Botox Dominates the Market, But Safety Concerns Linger
Botox, a medical and cosmetic injection that has been on the market for 34 years, is the leading player in the medical aesthetics field. It generates approximately $5 billion in annual revenue for AbbVie, which acquired the drug through its buyout of Allergan in 2019. However, Public Citizen is not only targeting Botox but also its competitors, including Revance Therapeutics’ Daxxify, Evolus’ Jeuveau, Supernus Pharmaceuticals’ Myobloc, Galderma’s Dysport, and Merz Therapeutics’ Xeomin. All of these products contain a potent neurotoxin that can be used for cosmetic purposes or to treat medical conditions such as migraines and incontinence.
The Call for Stronger Safety Warnings
Public Citizen’s main concern is the potential safety risks associated with these neurotoxin-based injections. The group is calling on the FDA to strengthen the black box warning, the strongest warning required by the FDA, in the labeling of all approved Botox and related drugs. Specifically, Public Citizen wants the warning to explicitly mention the risk of “systemic iatrogenic botulism,” a potentially serious complication that can cause muscle paralysis or weakness. The group argues that the current warning, implemented by the FDA in 2009, is insufficient and fails to adequately address this risk.
Misleading Promotional Statements Under Scrutiny
In addition to safety concerns, Public Citizen is also targeting misleading promotional statements found in the labeling of Botox and Botox Cosmetic. The group points out a specific claim that states there have been no definitive serious adverse event reports of distant spread of toxin effect associated with the recommended doses of these drugs for certain therapeutic indications and approved cosmetic uses. Public Citizen argues that this claim is misleading, as regulators in other countries, such as Canada and the U.K., do not make the same assertion. Furthermore, the group conducted an analysis of the FDA’s safety database and found that Botox was the primary suspect in adverse reactions related to the four therapeutic indications listed in the misleading claims. They also noted that 42% of these adverse reactions were suggestive of iatrogenic botulism.
Public Citizen’s History with Botox
Public Citizen has a longstanding history with Botox. The group originally petitioned for a black box warning on the drug in 2008, and while the FDA implemented the warning in 2009, Public Citizen believes it is still inadequate. The group’s continued efforts to address safety concerns and misleading promotional statements reflect their commitment to ensuring the public’s safety and holding pharmaceutical companies accountable.
Conclusion:
Public Citizen’s petition to the FDA regarding the safety and promotion of Botox and rival injections highlights the ongoing concerns surrounding these neurotoxin-based products. The group’s call for stronger safety warnings and the removal of misleading statements aims to protect consumers from potential risks associated with these popular cosmetic and medical treatments. As the FDA considers Public Citizen’s petition, the outcome of this advocacy effort could have far-reaching implications for the medical aesthetics industry and the way these products are marketed and regulated.
