FDA plan to combat fraud by compounders would boost patient safety

FDA is taking a multipronged approach to curbing drug compounding fraud that seeks to lower costs as well as improve patient safety.

FDA is taking a multipronged approach to curbing drug compounding fraud that seeks to lower costs as well as improve patient safety. The steps include increasing data available about compounded topical pain creams, searching for evidence of inappropriate practices when inspecting facilities, and providing information on drugs that are part of some fraud schemes. When announcing the plan on June 28, FDA Commissioner Scott Gottlieb cited recent federal enforcement actions targeting multiple health care fraud schemes. Defendants allegedly billed Medicare, Medicaid, Tricare, and private insurance companies for treatments that were medically unnecessary and sometimes not even provided. Compounding pharmacies allegedly combined certain ingredients to increase the amount they could charge for medications that were not needed, including compounded pain and scar creams. Meanwhile, research by The Pew Charitable Trusts has found that more than 70 reported compounding errors or potential errors from 2001 to 2017 were connected to 1,416 adverse events, including 115 fatalities. Additional illnesses and deaths tied to compounded drugs likely go unreported. Additionally, a 2015 survey by Pew found that only 30% of states require sterile compounding pharmacies to report serious adverse events to state authorities, FDA, or both. These cases show that the consequences of improper prescribing of compounded medicines can not only cause insurer losses but also put patients at risk.