Daily Newsletter

14 September 2023

Daily Newsletter

14 September 2023

FDA calls out eight companies for selling unapproved eye drugs

Companies that include Walgreens Boots Alliance and CVS have received warning letters from the FDA.

Phalguni Deswal September 13 2023

The US Food and Drug Administration (FDA) has sent warning letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.

The companies which received the warnings include CVS Health, Walgreens Boots Alliance, Boiron, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, TRP company, and Similasan.

The companies must respond with steps to correct violations within 15 days of receiving warnings. Failing to comply could lead to the FDA pursuing legal action, including product seizure and/or a court order to the company to stop unapproved product manufacturing and distribution. The FDA has already placed an import alert on some of the eight companies, stopping the entry of these drugs into the US.

The illegal eye products were marketed for varied ocular conditions, including conjunctivitis (pink eye), cataracts, and glaucoma. Some of the eight companies had product sterility issues, as per the FDA.

The heightened risk of harm is of particular concern to the FDA, as the topical eye application of these drugs can “bypass some of the body’s natural defences” and cause adverse reactions. Furthermore, some of the drugs contain silver compounds, namely silver sulphate, silver sulphate or argentum. Long-term use of silver can cause discolouration of the eye (argyria), causing it to turn grey or blue-grey.

The FDA noted that the investigation into the eye products is ongoing and may result in additional regulatory or enforcement actions. The agency also advised that the customers using the drugs should seek medical advice and report any adverse reactions on the FDA’s MedWatch program.

In January, the FDA issued a warning letter to online pharmacy pharmahealthonline.com for selling unapproved and misbranded drugs, including opioids and benzodiazepines.

US pharmacies including  CVS Health and Walgreens Boots Alliance have taken steps to maximise profits. In August, CVS Health partnered with Sandoz for the commercial launch of Humira biosimilar, Hyrimoz, in Q1 2024. Meanwhile, Walgreens Boots Alliance has instituted a cost management programme to save $3.5bn to $4.1bn.

Significant opportunities and risks for disease-modifying therapies (DMTs) entering the PD market

As PD therapy currently centers on symptomatic treatment, the need for DMTs is one of the greatest unmet needs. Several companies within the late-stage PD pipeline are developing drugs that target PD via novel MOAs. KOLs remain hopeful that these companies will uncover a class of drugs that works effectively to slow or modify the disease course. Targeting α-synuclein and other neurotoxic proteins is a key strategy in the late-stage pipeline for DMTs.

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