Congress to consider regulating lenses

September 15, 2005

Washington, DC—Members of the House of Representatives are expected to consider this fall a bill that identifies all contact lenses as medical devices that should be regulated by the FDA.

Washington, DC-Members of the House of Representatives are expected to consider this fall a bill that identifies all contact lenses as medical devices that should be regulated by the FDA.

The bill would regulate cosmetic plano contact lenses-the kind frequently sold over the counter in such places as video rental stores and gas stations to unsuspecting teenagers who never learn the dangers of sharing contact lenses and that are not properly fitted. It would require all contact lenses to be inspected and approved by the FDA.

A companion bill, sponsored by Sens. Mike DeWine (R-OH) and Edward Kennedy (D-MA), passed the Senate on July 29. The House bill is being sponsored by Reps. John Boozman (R-AK) and Henry Waxman (D-CA). A similar version of the House bill passed unanimously during Congress' 2003-2004 session, but it was not brought before the Senate floor for consideration.

In a report in the October 2003 issue of Eye & Contact Lens, Dr. Steinemann detailed six patients who developed serious complications, including two who required lengthy hospital stays-one needed a corneal transplant and the other remains legally blind. He recently documented another 12 cases, where four of the patients developed blinding infections that required hospitalization and another that required a corneal transplant. Results of that study will be published this month in Eye & Contact Lens.

"It really doesn't matter why it's on the eye, if it's a contact lens it needs to be regulated through the FDA, (and) it needs to be dispensed with a fitting and prescription by an eye-care professional," Dr. Steinemann said.

With Halloween approaching, Dr. Steinemann said he hopes to increase educational efforts with teenagers and young adults. He is working with several groups-including Prevent Blindness America, the Contact Lens Institute, and the Contact Lens Association of Ophthalmologists-to inform consumers of the dangers they face.

Dr. Steinemann said he thinks the bill has support in the House and was pleased with the attention it received in the Senate. A call to Sen. DeWine's office was not returned.

"I strongly feel this is a big issue for young people," said Dr. Steinemann, who has lobbied on this issue for 2 years. "I wish we could say we've seen a reduction or that people are more cautious, but I don't think so."