Valisure founder and CEO David Light testified on Tuesday June 2 at the US Senate Finance Committee, chaired by Senator Chuck Grassley of Iowa .
Title: Hearing on the FDA’s Foreign Drug Manufacturing Inspection Process
Here is the opening testimony:
Here are questions from Senator Grassley and answers from David Light.
Here are the first few paragraphs of US Senate testimony by David Light. Download the full oral testimony here.
COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process Hearing before the United States Senate Committee on Finance June 2, 2020
Testimony of David Light, Founder and CEO, Valisure
Chairman Grassley, Ranking Member Wyden, and distinguished Members of the Senate Finance Committee, thank you for holding this important hearing. My name is David Light, and I am the Founder and CEO of Valisure.
At Valisure, our mission is to help ensure the safety, quality, and transparency of medications, and we do this with a very simple but novel approach: we check. Valisure is an online pharmacy attached to an analytical laboratory. We are the first and only pharmacy in America that chemically batch-validates every medication we sell, and we do it at no additional cost to consumers. Founded in 2015, Valisure is headquartered at Yale Science Park in New Haven, Connecticut. Valisure is ISO-17025 accredited by the International Organization for Standardization (ISO) and is registered with the Drug Enforcement Administration (Pharmacy: FV7431137, Laboratory: RV0484814) and the Food and Drug Administration (FDA) (FEI #: 3012063246).
In response to rising concerns about medication quality, counterfeit medications, and overseas manufacturing, Valisure developed proprietary analytical technologies that we use in addition to the FDA’s standard assays to test every batch of every medication we dispense. Valisure tests medications for correct dosage, major inactive ingredients, proper dissolution, and the presence of carcinogens such as N-Nitrosodimethylamine (NDMA). Currently, we reject over 10% of on-market medication batches based on these testing standards. With roughly 80 percent of ingredients in U.S. medications manufactured in India and China, medication quality is constantly called into question. There are roughly three drug recalls in the U.S. every day and about 100 of those recalls every year are “Class I,” which are considered potentially life-threatening. These recalls can be attributed, at least in part, to the fact that the chemical quality of medications is primarily checked by manufacturers, which self-report the results. Most manufacturers are located overseas, where oversight by the FDA is difficult and fraud is commonplace. These general difficulties are only made worse by the COVID-19 pandemic.