Contact Lens Rule Summary
Ten years ago, Congress developed and enacted the Contact Lens Rule in response to ongoing litigation surrounding contact lens prescription availability and internet sales of contact lenses. In it, requirements were set forth for both the mandatory release of contact lens prescriptions by eye care providers (ECPs), and for mandatory prescription verification by internet and other resellers. The rule represented a compromise for both retailers, who felt that ECPs were withholding prescriptions in order to retain sales, and ECPs, who sought to prevent the unauthorized sale or substitution of contact lenses (classified in the U.S. as medical devices) without a current, valid prescription.
Since then, CooperVision and the Coalition for Patient Vision Care Safety have worked tirelessly to encourage ongoing review of the Contact Lens Rule in the interest of preserving the doctor-patient relationship and encouraging safe contact lens dispensing practices. In 2016, the Contact Lens Rule underwent a mandatory review by the Federal Trade Commission which included public comments about the rule and its impact. Stemming from that review came a proposal that ECPs be further required to have every contact lens patient sign an acknowledgment that they have received their finalized contact lens prescription. This proposal is currently pending further review and public comment and a final ruling is expected in 2017.
The proposal has been met with opposition by ECPs and professional organizations alike. A counterproposal from the AOA suggests that ECPs instead post signs in their office notifying patients of their right to a written prescription. CooperVision, both independently and through its participation in the Coalition for Patient Vision Care Safety, has also opposed this additional burden on ECPs, especially because it does little, or anything, to protect patient health and safety. Earlier this week, senators Richard Blumenthal (D-Conn) and Orrin Hatch (R-Utah) urged the FTC to proceed with the proposed changes to the rule, stating that "...the FTC proposed reforms will improve the eyecare providers' compliance in releasing contact len prescriptions." CooperVision believes that these changes fail to address important patient-safety issues, including passive-verification robocalls, excessive-quantity sales and lens substitution.
Michele Andrews, OD, Senior Director of Professional and Academic Affairs at CooperVision, actively participates in the Coalition’s ongoing efforts to advocate for ECPs and has visited with members of Congress on Capitol Hill many times regarding this issue. “It is important to continue educating our elected leaders and their teams about patient health and safety and the important role of the eye care professional in the contact lens experience,” says Andrews. “We will continue to participate in efforts that seek to balance patient access to products and protect their long-term eye and vision health.”
The Coalition for Contact Lens Patient Safety launched a web site – www.visioncaresafety.org. On the Coalition’s web site, you can learn more about the Coalition’s activities and get the latest information about some of the federal activities related to the contact lens industry. More importantly, the web site allows patients and eye care professionals to take direct action by sending their own letters to the FTC about the importance of patient safety. We encourage you to visit the web site and make your voices heard. In addition, we are hoping that federal legislation is re-introduced in order to improve the Fairness to Contact Lens Consumers Act. If such legislation is presented, CooperVision’s team is ready to provide lobbying and other resources in support of getting a meaningful bill passed into law.
As we await the final outcome of the Contact Lens Rule’s 10-year review, CooperVision remains committed to advocacy on behalf of ECPs everywhere and to our ongoing support of the profession.
*Source: : https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/contact-lens-rule