FDA Gives Company Cease and Desist Letter for Online Sale of Prescription Diagnostics
​​​[Posted on: Thursday, June 7, 2018]

In a stern letter to Tiger Medical of New Jersey, FDA directed the company to stop selling its HIV diagnostic test online. Tiger medical got approval for its Alere Determine™ HIV-1/2 Ag/Ab Combo test kits in 2013 and had been marketing the test online on its website. It was obvious that anyone could purchase the test online directly from the company without prescription which is in violation of the conditions of market approval. As an In Vitro Diagnostic (IVD) approved via a 510k application, Alere Determine can only be sold upon prescription from a licensed physician. FDA stated that since the company did not follow this practice, it was in effect selling a misbranded product. It is to be noted that it is legal to sell prescription products online provided the seller verifies a valid prescription. In Tiger Medical’s case, they would not have been in trouble with FDA if they had added a process to collect prescriptions from the purchasers. It should be noted the besides the sale without prescription, there were no other issues identified by the FDA; the company was selling a product that was formally approved by the FDA. Compare that to the sale of laboratory developed tests (LDTs). There are thousands of unapproved tests available freely online as a laboratory developed tests (LDTs), many of which are for serious diseases including infectious diseases like Alere Determine. FDA does not regulate LDTs so those tests can be sold freely without any fear of FDA actions. FDA has never issued Warning Letters to any LDT providers. Life isn’t fair, is it!