Background of the VDIP® Program
The Accreditation is the first to be awarded since the Verified- Accredited Device Integrity Program® (VDIP®) was launched on September 23, 2016. Per the website, the VDIP® Program was created to regulate “OTC medical device distribution [which] is largely unregulated in the United States.”
The problem of a questionable integrity on test strips is very real – here is an excerpt from a previous article:
The diabetic testing supply (DTS) “Gray-Market” was first widely reported on in 2012 but experts estimate that the market has been steadily growing since at least 2002. The idea behind the gray market is that companies receive products at a lower cost than what pharmacies would otherwise have to pay their primary wholesalers. Gray market companies achieve this through one of two ways: (1) purchasing from patients/consumers who obtained the diabetic test strips through Medicare or other health insurance plans for free or for a very reduced cost; or (2) purchasing from wholesale distributors who divert them from their intended sales channels (e.g. mail-order pharmacies, Medicare suppliers) and instead sell them to the general public (e.g. Amazon, eBay).
This model is (generally) legal because the sale and distribution of OTC supplies are (generally) not restricted. Because of the low barrier to entry and the lucrative profitability, revenues from this gray-market is easily into the hundreds of millions, potentially billions – all achieved by putting diabetic patients at risk.
The first and, for now, only VDIP® Accredited company is a manufacturer, which is basically a eliminates the concern product was procured on the “gray” market.
The first Accreditation was awarded about 40 months from when the Program was first started. NABP® has been put under significant pressure to improve their processing times and customer service for another Accreditation program, VAWD® because frustration with the Program has grown within the industry over the past five years.
Optum Rx Requirement
The VDIP® Program raised many eyebrows when first launched because the Program started only about a month after Optum Rx announced that they would require wholesalers selling prescription drug products to obtain VAWD® Accreditation; and only seven (7) days before the requirement was implemented on October 1, 2016. Due to the timeline, some members of industry believe that the development of the VDIP® Program was only due to Optum Rx.
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