Illegal Lens Sales
BY JOSEPH T. BARR, OD, MS, FAAO, EDITOR,
AND MICHAEL G. HARRIS, OD, JD, MS
Last month our annual contact lens report and an article, "Mail Order Contact Lenses: A Telephone Survey," addressed this important issue. Similar issues apply to Internet lens sales. In most states contact lenses cannot be provided without a signed copy of the prescription from an optometrist or ophthalmologist. Some states do not allow prescription substitutions, and some require that eyecare questions be referred back to the prescribing practitioner.
Filling an invalid lens prescription implies that the eye care provider is unnecessary and diminishes the role of a contact lens as a medical device. The probability of contact lens-related problems increases when a patient fails to see an eyecare provider on a regular basis or wears improperly prescribed contact lenses. Other possible problems are illustrated in the September 7, 1999, Prospectus filed pursuant to rule 424 of the Securities Exchange Commission Filing Form 424B1 for one major contact lens mail order company (1 800 Contacts). It states under "Risk Factors" that: "A significant portion of our sales do not comply with applicable regulations governing the delivery and sale of contact lenses." The company also admits these risks:
- "Many of the states requiring that contact lenses be dispensed in face-to-face meetings or by a person licensed by such state to dispense lenses also require that lenses only be dispensed pursuant to a valid prescription. Neither we nor any of our employees is a licensed or registered dispenser of contact lenses in any state other than California and Texas."
- "If we are unable to obtain a copy of or verify the customer's prescription, it is our practice to ship the lenses to the customer based on the information that the customer has provided."
- "We estimate that approximately one-third of our net sales in 1998 appeared to conform to the requirements of applicable state laws and regulations."
- "We sometimes sell lenses based solely on the prescription information provided by the customer without a written prescription or other order by the customer's eye care practitioner." And later, "The sale of misbranded devices is unlawful."
- "We do not investigate the sources from which our suppliers obtain the contact lenses we sell. These sources may include foreign establishments. Contact lenses manufactured either abroad or domestically for the export market may not comply with the good manufacturing practice standards established by the FDA."
- "We obtain a large percentage of our inventory from a limited number of suppliers...our top three suppliers accounted for approximately 72 percent and 70 percent of our inventory in 1997 and 1998, respectively. We believe that none of these suppliers is authorized by contact lens manufacturers to distribute their products."
Last month's article indicates that at least one mail order contact lens company may not comply with (California) state law regarding contact lens prescriptions and advice. What action should be taken? We will address this next month.