Fiction, Fantasy, Fib or Fact?

FACT: Biologic eye drops are regulated by the FDA Center for Biologics Research and Evaluation (CBER).

Contact the Product Jurisdiction office at CBER to verify this information (240-402-7912).

FACT: Biologics have an entire FDA branch dedicated to serving them.

Biologics are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER).

Here’s a great link about how the FDA regulates biological products.

FACT: They require approval. Here’s a great link explaining more.

FACT: According to the FDA, using bone as a bone graft is one thing, grinding up someone’s placenta to make eye drops is another.

Certain products derived from human tissue are classified as HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products.) Some HCT/P can be exempt from the years-long, extremely expensive drug or device approval processes. They are still regulated by FDA’s Center for Biologics Evaluation and Research (CBER), but they are subject to a much less burdensome set of requirements. However, they have to pass four tests to qualify for this exemption.

According to CBER, eye drops made from placenta or amniotic fluid do not qualify as exempt HCT/P. First, they fail the exemption tests. Second, proteins and exosomes - regardless of tissue or fluid source - are regulated as biologic products, and biologic products are regulated as drugs that require FDA approval before being marketed and sold as a treatment for disease.

For verification, please feel free to contact CBER, like we did.

FACT: Federal law defines a drug as “a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. (See FDA glossary.)

Prescription eye drops, over-the-counter eye drops and homeopathic eye drops are all examples of ophthalmic drugs.

Manufacturers that want to deceive consumers about their regulatory compliance status sometimes claim that their products are “not drugs.”

FACT: Again:

Biologics are regulated by FDA’s Center for Biologics Evaluation and Research (CBER).

Biologics are not and cannot be compliant with the OTC monograph.

FACT: The FDA laughed out loud when we repeated this one to them.

Once more, and we say this with love:

Biologics are regulated by FDA’s Center for Biologics Evaluation and Research (CBER).

FACT: Water is natural. When it is contaminated, it is not safe.

Any preservative free substance packaged in a simple multi-dose bottle may become contaminated and, once contaminated, may cause harm.