Author ORCID Identifier

0000-0002-1435-0197

Document Type

Article

Publication Date

2019

Keywords

Drug compounding, FDA, Patient safety, Fraud, Regulatory oversight

Abstract

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound a liquid version of the drug.

Although drug compounding fills a critical need for many patients, it has also given rise to significant drug safety concerns, fraud, and anticompetitive practices. Every year, many patients experience harmful side effects and even death from compounded drugs that are contaminated or made in excessive potency because of pharmacist error. The ability of pharmacies to make and dispense drugs outside of the typical channels has also given rise to extensive fraud. Pharmacists, doctors, and company executives are routinely prosecuted for schemes to defraud insurers and the federal government into paying hundreds of millions of excess dollars for compounded drugs. In addition, some rogue pharmacies earn significant profits by mass-producing compounded drugs that are essentially copies of commercially-available drugs. These facilities put patients at risk by needlessly exposing them to unapproved drugs and jeopardize drug innovation by reducing manufacturers’ incentives to invest in the development of new products.

Many of the drug safety problems, fraudulent practices, and anticompetitive behaviors are facilitated by regulatory gaps in the oversight of drug compounding. Traditional drug manufacturers must prove that their drugs are safe and effective and manufactured in accordance with current good manufacturing practices (CGMPs) in order to obtain U.S. Food and Drug Administration (FDA) approval. In contrast, compounders need not obtain FDA approval for their drugs before selling them, and most compounders do not have to produce drugs in accordance with CGMPs. Moreover, traditional drug manufacturing facilities are subject to routine inspection by the FDA to ensure they comply with CGMPs and there are no other safety or quality concerns. In contrast, most compounders are not primarily overseen by the FDA but by state boards of pharmacy that are less consistent in their oversight—in fact, fewer than half of the states conduct routine inspections of compounding pharmacies. Finally, whereas traditional manufacturers are required to report adverse events involving their drugs to the FDA, most compounders do not have to report adverse events to either the FDA or state regulatory authorities.

This Article explains the regulatory gaps in drug compounding that give rise to drug safety problems, fraud, and anticompetitive behavior. It also proposes various measures that could be taken to close the gaps in order to protect patients, payors, and innovation.

First Page

385

Publication Title

DePaul Law Review

Comments

Digital Commons@DePaul © 2019

Download

Share

COinS