WebMD Faces Lawsuit Over Alleged Illegal FDA Approval Of STD Kits

WebMD Faces Lawsuit Over Alleged Illegal FDA Approval Of STD Kits

A lawsuit has been filed by a nonprofit “industry watchdog” against WebMD’s consumer STD lab tests for allegedly misrepresenting its tests as being FDA approved.

The agency, Responsible Telemedicine, filed the suit after it found that just three of the nine offered STD tests the company marketed and sold underwent premarket approval set up by the U.S. Food and Drugs Administration – the process in which the FDA approves a laboratory testing kit.

The lawsuit also alleges that five of the nine tests are noted as being cleared instead of approved, which means the process for premarket notification is not as strict. The five tests are chlamydia, gonorrhea, hepatitis A, herpes 1, syphilis and female trichomoniasis. The male trichomoniasis, they allege, has not attained any approval from the FDA.

Responsible Telemedicine Executive Director Aadel Sarfani said misrepresenting the approval process of a clinical diagnostic test is a huge breach of trust and a major misrepresentation of its products. Sarfani said it was important to improve telemedicine’s quality, and what WebMD is doing is not helpful in the effort.

According to the nonprofit, WebMD claims a physician will do a review to ensure the testing was correctly done. However, the suit states patients are not for any medical conditions or history – making such a review difficult.

Why Is This So Important

Digital health and telemedicine are still very new to the healthcare market, and the industry is trying to find its place in the healthcare market.

Sarfani said people need to have some trust in telemedicine if it’s to be successful. For sites like WebMD to break the trust, it makes it harder for people to trust the industry. This is why immediate action is necessary to combat the problem and look for answers when false claims are made and misleading consumers, Sarfani said.

WebMD Isn’t The Only One Facing Scrutiny

WebMD isn’t the first digital company to face legal problems. For example, uBiome, which is a groundbreaking direct-to-consumer microbiome testing company, was invested by the FBI last year for its deceitful billing practice such as double-billing insurance companies for tests, using inappropriate billing codes, or illegally compensating telemedicine doctors referring patients to use uBiome.

Written by Mark Riegel, MD

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