What does the phrase “FDA approved” really mean? According to the US Food and Drug Administration (FDA), “FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use1.”
For the FDA to fully understand the benefits and risks of the products it is reviewing, it relies heavily on documentation from clinical trials. Clinical trials are costly and involve coordination and cooperation from multiple parties, including patients and clinicians. These trials often span years; however, the results they achieve can help immensely in the journey to FDA-approval.
Differences Between FDA Approved & Non-FDA Approved Cross-Linking
The only FDA approved procedure to treat progressive keratoconus is epi-off cross-linking performed with Avedro’s Photrexa® Drug Formulations – Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) and the KXL® System.
Epi-on cross-linking and Holcomb C3R have not been approved by the FDA. The safety of unapproved drugs and devices is not established, and there may be risks to undergoing the procedure that are unknown or unreported. In addition, non-FDA approved treatments are generally not covered by insurance.
FDA Approved Cross-Linking and Insurance Coverage
Not only is FDA approval important for verifying the safety and efficacy of a drug or medical device, but it also enables insurance companies to review the FDA’s findings to determine their coverage policies. Most of the current insurance policies for cross-linking specify that only epi-off cross-linking performed with FDA approved Photrexa drug formulations is eligible for insurance reimbursement.
Off-label usage refers to when an FDA approved drug or medical device is used for a purpose for which it does not have regulatory approval. Cross-linking procedures such as epi-on, which use a drug other than the Photrexa drug formulations, or a device other than the KXL system, are considered “unapproved” products by the FDA and can only be studied under an FDA clinical trial.
Choosing FDA approved cross-linking allows patients to verify that the drug products and equipment have been proven safe and effective. Cross-linking procedures that have not been approved by the FDA do not have this same government-regulated verification. By undergoing unapproved procedures, patients may be putting themselves at risk.
Approaching your doctor to learn more about FDA-approved cross-linking can be intimidating but preparing a list of questions ahead of time can help you remember everything you want to ask. Check out these questions to kick off the conversation with your doctor about FDA-approved cross-linking.
If your physician does not offer FDA approved cross-linking, our Find an Expert tool can help you find a physician near you.
1U.S. Food & Drug Administration. (2017, January 17). Consumer Updates - Is It Really 'FDA Approved?' Retrieved from https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm.