Milestones :: Perspectives :: Research
Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on FDA’s new report regarding root causes and potential solutions to drug shortages
Oct 29, 2019, 11:05 ET
…Today, on behalf of the inter-agency Task Force, the FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions,” that attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs, but many of the same concerns apply to veterinary medicines used to treat service, companion, and food-producing animals.
The Task Force found that the number of ongoing drug shortages has been rising, and that their impact is likely underappreciated. The Task Force analyzed 163 drugs that went into shortage from 2013 to 2017 and compared these medicines to similar drugs that did not go into shortage. Shortage drugs were more likely to be relatively low-price and financially unattractive drugs and were more likely to be sterile injectables. Shortages often occurred as a result of disruption in supply due to a variety of factors. Importantly, prices rarely rose after shortages began, and during shortages, production typically did not increase enough to restore supply to pre-shortage levels. Many manufacturers reported discontinuing the production of drugs before a shortage for commercial reasons (e.g., loss of profitability)…
Drug Shortages: Root Causes and Potential Solutions
A Report by the Drug Shortages Task Force 2019
FDA, October 2019 :: 124 pages
Drug Shortages: Root Causes and Potential Solutions examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug Shortage Task Force, which was led by FDA, oversaw the analysis of drug shortage data and development of recommendations in response to a request from 31 U.S. senators and 104 U.S. congressional representatives in June 2018. The report relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages.
The report identifies three root causes for drug shortages:
:: Lack of incentives for manufacturers to produce less profitable drugs;
:: The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
:: Logistical and regulatory challenges make it difficult for the market to recover from a disruption.
The report also recommends enduring solutions to address drug shortages. These solutions include:
:: Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
:: Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
:: Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.
In addition, the report describes legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages that look at improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system.