The U.S. Food and Drug Administration (FDA) has issued a warning to CVS Health Corp. and Walgreens Boots Alliance Inc., along with several smaller consumer products companies, regarding the marketing of unapproved eye products. This announcement comes amidst concerns that these unlawfully marketed ophthalmic drugs pose an elevated risk of harm to users due to the bypassing of natural ocular defenses.
Heightened Risk of Harm
In a press release issued on Tuesday, the FDA expressed particular concern over the potential dangers associated with these unapproved eye products. The application of drugs to the eyes negates certain protective mechanisms in the body, amplifying the risk posed to users. Consequently, the FDA has taken action to address this issue.
Unapproved New Drugs
In a letter addressed to Walgreens on Monday, the FDA highlighted several eye-drop products available on the company’s website that are considered unapproved new drugs. The delivery of these products across state boundaries may be in violation of federal law. Similarly, a letter was also sent to CVS, cautioning against the sale of “CVS Health Pink Eye Relief Drops” on their website.
Manufacturing Concerns
The FDA not only expressed apprehension regarding the marketing of these unapproved eye products but also raised concerns about the manufacturing practices employed by the contract manufacturers responsible for producing them. Such concerns further reinforce the urgency for corrective actions.
Taking Action
The FDA has given CVS and Walgreens, along with the other implicated companies, 15 working days to inform the agency of the measures they have taken to rectify the violations. However, CVS and Walgreens have yet to respond to requests for comment.
As a result of this announcement, CVS shares experienced a 0.7% increase on Tuesday, while Walgreens stock saw a 0.6% gain.
These warnings issued by the FDA emphasize the importance of adhering to regulations and ensuring that all eye products undergo the necessary approval processes. By doing so, the safety and well-being of consumers can be adequately protected.