16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
The FCLCA in its current format being abused. The most egregious abuse is the passive prescription verification. Under the current law, retailers are allowed to fill a prescription if verification is not received within 8 hours. This is most commonly exploited by faxing or robot-dialing verification requests outside of normal business hours, then filling the prescription before the prescriber responds. Since contact lens retailers are aware of these loopholes, they have no concern with substituting lenses. A study of contact lens consumers purchasing from online retailers performed earlier this year found 25% of consumers had a lens substituted with no prior notification and 33% had been advised to substitute a different lens material without a doctor's permission. Contact lenses are designated as a medical device by the FDA and unauthorized substitutions places the health of the patient's eye at risk. This would be comparable to a pharmacy substituting a different class of anti-hypertensive than what was prescribed without seeking permission from the doctor. I have personally seen poor outcomes of contact lens wear and am always frustrated, although no longer surprised, when my patients' eye health is jeopardized in this fashion. Given modern communication techniques widely available (email, text message, etc.) and the history of abuse of passive verification by contact lens retailers, verification of contact lenses should be modified to an active verification of the prescription and expiration date. Patients are already required to be given a copy of the prescription at the examination. It should not cause any hardship to patients and may protect their long-term visual health to require retailers to receive and actively verify the prescription prior to filling any requests.