Congress has asked to review companies such as Hubble Contacts which may not be adhering to regulations for the sale of prescription contact lenses. Photo: Getty Images.

A coalition of US Congress members is calling for a federal review of direct-to-consumer (DTC) prescription medical device practices, specifically noting that appropriate regulatory oversight may be lacking in the sale of products such as contact lenses.¹

In a December 6 letter to the US Comptroller General, 21 US House members asked the Government Accountability Office (GAO) to launch a formal study looking into the federal regulation of DTC advertising (DTCA) for prescription medical devices.² The letter included mentions of media articles that purported Hubble Contacts skirted federal regulations.²

Brian Chou, OD, of San Diego said he feels encouraged that members of Congress are looking at this issue, which he says is long overdue. DTCA of drugs is banned in virtually every country except the US and New Zealand because their use without professional supervision can lead to adverse consequences, he explains.

“By extension, consumer protections are also a must to safeguard citizens from harm by medical device advertisements,” Dr. Chou says. “The drug and medical device companies have generally failed at self-regulation, so this is where government intervention is welcome.”

While there are regulations currently in place governing DTCA, the fast development of new technology has outpaced the slow process of government regulation, he adds.

On the surface, it seems odd there are advertisements directed to consumers because the ads are for products which individuals don’t have prescriptive authority to buy on their own, Dr. Chou suggests.

“Yet the high return-on-investment for this advertising perpetuates this sales strategy,” he says.  “The advertisers know they can get consumers to influence prescribers to give what they want.”

Hubble DTCA Trouble

While products advertised directly to consumers have the potential to increase convenience and lower costs, concerns have also been raised about reports of poor quality or adverse events related to these products, the letter states.2 Additionally, some DTC products allow consumers to bypass evaluation or supervision by a healthcare provider entirely, which may be appropriate for some products but not for others, the letter continues.

Case in point: Hubble Contacts.

“An online distributor of contact lenses is accused of using older materials and switching prescribed lenses for other brands, which doctors allege affects the safety of the lenses,” the Congress members wrote in the letter. “Advocacy groups and other complaints further allege that the company skirts existing prescription verification requirements under the FTC’s Contact Lens Rule.”²

The example of Hubble Contacts is egregious since previous articles cited in the New York Times and Quartz found instances in which the eye care company allegedly substituted contact lens prescriptions for their own contacts fabricated using a legacy contact lens material, says Dr. Chou.

“The suggestion here is that profit was placed ahead of health and safety,” Dr. Chou suggests.

Yet it isn’t just Hubble that participates in DTCA. Major soft disposable contact lens manufacturers promote “free trial lens” coupons to consumers without clearly disclosing that professional services are desirable and necessary and that they carry a corresponding financial responsibility, Dr. Chou adds.

Additionally, DTCA generally seeks to strengthen the patient’s relationship and loyalty with the brand of contact lens, concurrently minimizing the importance of the practitioner, Dr. Chou suggests.

“That’s why I encourage my colleagues to seek partnerships with the drug and medical device companies that understand their products are to enhance the patient-doctor relationship rather than disrupt it,” he says.

Based on the concerns raised in the letter, House members are asking the GAO to investigate the following:²

• What are the known advantages and concerns of marketing medical products that require prescriptions or other provider evaluation, such as contact lenses, directly to consumers?

• What actions are federal agencies, such as the FDA and the FTC, taking to address any identified concerns?

• Are there limitations to the FDA or FTC’s ability to enforce existing laws and regulations governing DTCA of prescription medical products and, if so, what are they?

DTC Weakens Doctor-Patient Relationship

The AOA has long spoken out against DTC contact lens sale schemes that seek to disrupt the doctor-patient relationship and other online vendors that circumvent federal contact lens market laws and regulations, placing a greater emphasis on convenience than patients’ vision and eye health.¹

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.¹

On the ground level, a common argument from drug and medical device companies that advertise directly to consumers is that they are educating the public about better treatments while opening discussions these individuals can have with their doctor, Dr. Chou suggests.

While this is true and helpful in specific cases, these advertisements can also confuse the public by creating demand for more expensive and unnecessary treatments, he explains. Additionally, sometimes the advertisements make patients believe they have a condition that they don’t.

“This sets up the doctor to deliver disappointing news that a particular drug or medical device is not right for them,” Dr. Chou says. “So, despite the narrative by these companies that they are helping patients, they are in fact potentially hindering the relationship between doctors and patients.”

Adding to this argument, doctors have limited chair time, so inappropriate advertisements can subtract from the doctor’s discretionary time by imposing a burden of explaining why the marketed drug or medical device is not suitable, Dr. Chou adds.

“This is a travesty when doctor time could be allocated in a more fruitful manner for the patient. In other words, the non-specific approach of DTC drug and medical device advertising taxes practitioner time, which can in turn compromise patient care,” Dr. Chou says.