U.S. House, consumer groups mull federal action against DTC contact lens sales schemes

Concerned that regulatory oversight may be a step behind emerging direct-to-consumer (DTC) medical device sales schemes, members of Congress demand a federal inquiry into the sales practices with support from the AOA and a coalition of consumer and health care organizations.

In a Dec. 6 letter to the U.S. Comptroller General, 21 leading U.S. House members requested the Government Accountability Office (GAO) conduct a formal study examining the federal regulation of DTC advertising practices for prescription medical devices, specifically noting contact lenses and citing a New York Times article detailing how Hubble Contacts took advantage of federal regulations. Lawmakers’ concerns echo many of the health and safety worries that the AOA, media and consumer advocacy groups have highlighted for years with DTC prescription medical devices.

“The rise of internet marketing and the push toward a DTC model of healthcare delivery represents a major change within our healthcare system,” the bipartisan letter reads. “We are concerned that with the rapid growth of DTC advertising, appropriate regulatory oversight may be falling behind.”

Specifically, House members cited challenges to the doctor-patient relationship with some DTC products allowing consumers to entirely bypass routine evaluation or supervision by health care providers, as well as reports of poor quality and adverse events related to DTC products. The letter described an online contact lens vendor “accused of using older materials and switching prescribed lenses for other brands,” and advocacy groups alleging online companies skirting existing prescription verification requirements under the U.S. Federal Trade Commission’s (FTC’s) Contact Lens Rule.

Such is the case, House members called for the nonpartisan auditing and investigative agency to devise a study that could help evaluate and guide potential regulatory or legislative action, specifically examining:

Advantages or concerns of marketing medical products that require prescriptions, such as contact lenses, directly to consumers.

Actions that agencies, such as the FTC or the U.S. Food and Drug Administration (FDA), currently take to address identified concerns.

Limitations to these federal agencies’ ability to enforce existing laws and regulations governing DTC advertising of prescription medical products.

Notably, among the 20 bipartisan signatories are 14 members of the House Energy and Commerce Committee, as well as the chair and ranking members of two subcommittees with immediate jurisdiction over the federal agencies that manage and enforce these regulations. However, growing support for federal action also extends beyond Capitol Hill with a national consumers group endorsing congressional concerns.

‘Skipping over the expertise of health care professionals’

In response to the House letter, the National Consumers League (NCL) noted it “applauds and fully supports” the bipartisan call for a review of federal regulation surrounding DTC prescription medical device advertising practices.

“We have observed an increasingly common practice of skipping over the expertise of health care professionals in the delivery of certain medical services in an effort to deliver services and treatments directly to consumers at lower cost and more efficiently,” the NCL notes, adding that such conveniences cannot “come at the expense of consumers’ health and safety.”

Specifically, the NCL letter calls out DTC contact lens vendors with business models that seem to encourage consumers to bypass their doctors’ evaluation or supervision, and similarly, cited the New York Times article about patients suffering harm after DTC contact lens sellers substituted their own brands of contact lenses in place of what was prescribed.

In both circumstances—the House letter and the NCL’s backing—the appeal for federal action is something the AOA, Health Care Alliance for Patient Safety and other health care organizations strongly support and have advocated toward for years.

AOA’s contact lens patient protection advocacy

Long has the AOA spoken out against DTC contact lens sales schemes that seek to disrupt the doctor-patient relationship and other online vendors that skirt federal contact lens market laws and regulations, placing a greater emphasis on convenience than patients’ vision and eye health.

In addition to the New York Times’ 2019 article cited by lawmakers, a 2018 Quartz article and other subsequent media reports independently validated complaints the AOA first raised with enforcement agencies in 2017. At that time, the AOA sent letters to the FDA, FTC and Department of Justice asking for an investigation into retailer irregularities related to prescription verifications for its contact lenses.

Additionally, Quartz published an article detailing how its reporter circumvented the DTC contact lens vendor’s online ordering process with false prescription information. Concerningly, four other people were able to use bogus information to place orders, the Quartz reporter noted in her exposé.

Even as recently as the FTC’s Contact Lens Rule review, the AOA advocated for the necessity of a reformed contact lens prescription verification process with doctors’ reports of patients obtaining contact lenses without valid prescriptions or companies substituting doctor-prescribed lenses.

While contact lenses are a safe, effective vision correction option when worn and cared for properly, poorly fitting or improperly used contact lenses can result in serious eye health and vision complications. These FDA-regulated medical devices are not one-size-fits-all as is sometimes portrayed and require a doctor’s prescription and oversight to purchase as outlined by the Fairness to Contact Lens Consumers Act and Contact Lens Rule.

The AOA takes seriously its central mission not only serving as a reliable public resource on issues affecting eye health and vision care but also helping doctors of optometry safeguard patients’ eyesight. Better documentation of illegal contact lens sales helps the AOA build a case for increased enforcement by federal regulators.

Here’s how doctors can report illegal sales or adverse events related to contact lenses:

• Report a website illegally selling contact lenses.
• Report an adverse event related to contact lenses.
• Report problems with decorative contact lenses.
• Report a contact lens seller exhibiting poor business practices.
• Email a de-identified case report to StopIllegalCLs@aoa.org to help bolster AOA’s advocacy against harmful contact lens practices.

For more information on illegal retailers or incident reporting, contact AOA’s Chief Strategy Officer Kara Webb.