New FDA program incentivizes drugmakers to invest in quality measures

Photo: Willie B. Thomas/Getty Images

Quality issues are still the number one reason for drug shortages, and in an effort to address this, the U.S. Food and Drug Administration is debuting a quality management maturity (QMM) program intended to incentivize drugmakers to invest in quality measures.

The program will be run by the FDA's Center for Drug Evaluation and Research (CDER), which is developing its QMM Assessment Tool to evaluate how effectively establishments monitor and manage quality and quality systems. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.

In a white paper, the FDA cited four main goals: foster a strong quality culture mindset; recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve them; identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities; and minimize risks to product availability to assure reliable market supply.

WHAT'S THE IMPACT?

Mature quality management practices support a more reliable drug supply chain, the FDA said, by reducing the occurrence of quality-related failures and improving the ability of establishments to maintain performance during supply chain disruptions.

Integrating business and manufacturing operations with quality practices and technological advancements can help achieve higher levels of maturity, the agency said. This can optimize manufacturing process performance and product quality, as well as enhance the reliability of the supply chain.

The QMM of a drug manufacturing establishment may be best evaluated by a team of assessors using a standardized protocol. The next step in implementing the program is developing the protocol that assesses the QMM of manufacturing establishments. This prototype assessment protocol will be tested and refined during the 2024 calendar year, the FDA said.

The use of teams and a standardized protocol is intended to minimize bias and individual subjectivity in the assessment. The teams could be made up of FDA staff, third-party contractors or a combination. The prototype assessment protocol may include a series of questions to elicit responses that lend themselves to an assessment of an establishment's maturity.

The purpose of this approach is to create an environment where assessors and establishments can be open and transparent during the assessment, the FDA said. The protocol "will offer a structured, objective approach to evaluate an establishment's level of maturity," according to the white paper.

"The prototype assessment protocol will encourage establishments to embrace a holistic approach to quality management," the FDA said.

THE LARGER TREND

Shortages of prescription drugs can lead to higher drug prices and impact consumer's ability to fill their prescriptions, according to a July RAND report.

Drug shortages impact consumer costs in various ways, ASPE found. Consumers may incur increased costs in the form of higher out-of-pocket costs, higher insurance premiums and adverse health outcomes as a result of a drug shortage. Healthcare systems also incur costs to manage or mitigate drug shortages.

The average drug shortage affects at least a half a million consumers; more than two thirds of those impacted were consumers ages 65 to 85 (32%), 55 to 64 (24%) and 45 to 54 (17%).

A 2019 Vizient survey found that, on average, hospitals dedicate more than 8.6 million hours of additional labor hours annually to manage drug shortages. The financial impact adds up to just under $360 million annually in labor costs for time spent seeking supply and implementing mitigation strategies that enable continuity of patient care.

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com