Drug Shortage Resources

HSCA Statements, Letters and Drug Shortage Resources

HSCA Letter on Creating a More Competitive Generic Drug Market
"HSCA commends the goal of S.2615 to create a more competitive generic drug marketplace. We believe mandating priority review of abbreviated new drug applications (ANDAs) in single-source situations is critical to achieving that goal."

HSCA Statement on FDA’s Decision to Conduct Expedited Review of Generic Drug Applications for ‘Sole Source’ Products
"We applaud the FDA for taking this important first step to expand patient access to critical generic medications. Expediting the review and approval process for generic drugs with only one manufacturer will help increase competition in the market, mitigate generic drug price spikes, and alleviate future drug shortages."

HSCA Statement on Senate HELP Committee Hearing on GDUFA and Access to Generic Drugs
"It is essential that new manufacturers are able to enter the market in a timely manner to help increase competition and reduce costs. We urge Congress to give FDA authority to expedite review and approval for new generic drugs that have the potential to mitigate price spikes and help ensure access to critical medications for healthcare providers and the patients they serve."

HSCA Letter on Quality Metrics
"By leveraging quality metrics to make risked-based scheduling and prediction of drug shortages, FDA will advance product quality and quality manufacturing facilities, and mitigate threats that could put patients, providers, and the broader healthcare market in jeopardy."

FDA Says it's Fighting Drug Shortages
"We take this very seriously, and our customers do as well, and we are taking an active role to mitigate the problem as best as we can, knowing there are some things we can't manage,” said Todd Ebert, former CEO of St. Louis-based GPO Amerinet, who took over as president and CEO of the Healthcare Supply Chain Association this summer."

HSCA Urges Congress to take Action to Address Generic Drug Price Spikes
"The Healthcare Supply Chain Association (HSCA) today urged Congress to address price spikes in the generic drug market by granting the U.S. Food and Drug Administration (FDA) authority to expedite review and approval of new drug applications for products where there are two or fewer manufacturers, or in instances where there have already been price spikes."

Drug Shortages to be Addressed at Supply Chain Conference
"Drug shortages will be the major focus of concern when executives from healthcare suppliers and group purchasing organizations gather in Washington, D.C., this week for the 2015 Healthcare Supply Chain Expo."

GPOs Provide Savings, Value in Health Care
"GPOs save hospitals and long-term care providers, Medicare and Medicaid, and American taxpayers up to $55 billion every year. GPOs are also health care industry leaders in transparency and business ethics."

HSCA Statement on GAO, FDA Drug Shortage Reports
"The GAO and FDA today reaffirmed that the root causes of drug shortages are manufacturing problems, quality issues, and barriers to getting new suppliers on line when supply is disrupted. Drug shortages are a complex challenge with no overnight fix, but GPOs are committed to continuing to be part of the solution."

"The true cause of drug shortages is manufacturing problems, disruptions and barriers to entry in  getting new suppliers on line when there is a disruption in supply."

"The GPO mission is to contract for those products and services, including drugs, that are essential to the operation of hospitals and other healthcare facilities."

HSCA Letter to Secretary Sebelius on Drug Shortages
"GPOs play an important role in helping hospitals and other health care providers limit the impact of drug shortages and ensuring the least possible disruption to patient care by prompt and safe migration to alternative products, where possible."

"Healthcare group purchasing organizations (GPOs) have been working collaboratively with hospitals, manufacturers, distributors, the Department of Health and Human Services (HHS), and FDA to ensure that hospitals and patients have access to the life-saving drugs they need."

"Drug shortages, such as those involving saline solution and the antibiotic piperacillin/tazobactam that are currently challenging hospitals, represent a complex problem that affects the ability of hospitals and other healthcare providers to treat their most vulnerable patients. Though recent actions by government and industry stakeholders have led to reductions in new drug shortages, many ongoing shortages persist and represent a real public health threat." 

Official Drug Shortage Reports and Other Resources

The majority of information in this section is provided to FDA by manufacturers.

FDA Drug Shortage App
Access to drug shortage information is now easier and faster. FDA has developed an app that allows users to quickly identify current drug shortages, resolved shortages, and discontinuations of drug products.

FDA Drug Shortage FAQ
The following questions and answers are those that are most frequently asked and answered by the Center for Drugs and Evaluation and Research (CDER) Drug Shortage Staff.

FDA Drug Shortages Infographic

University of Utah Drug Information Service

Information on drug shortages from the University of Utah.

Government Accountability Office Report on Drug Shortages (2015)
"Shortages of prescription drugs containing controlled substances have increased sharply in recent years...Additionally, many shortages involved generic pain relievers and drugs where there was only one manufacturer."

Government Accountability Office Report on Drug Shortages (2011) 
"Drug Shortages: FDA's Ability to Respond Should be Strengthened." 

Avalere Report on GPOs and Drug Shortages
"Group purchasing organizations (GPOs) play a vital role in assisting hospitals to limit the impact of drug shortages and to ensure the least possible disruption to patient care by prompt and safe migration to alternative products, where possible."

"The practice of hospitals contracting with a GPO in order to aggregate their purchasing power is not a factor in drug shortages."

“Based on my experience, GPOs play a positive role in the process of locating, sourcing and supplying drugs to their member hospitals and therefore the patients who require these drugs.”

“It has been our experience, especially during times where a product is in critical need and considered to be in drug shortage, that GPOs are flexible, often working with multiple manufacturers in order to ensure supply to their members. We appreciate this partnership, and we hope that, together, we can continue to make progress against this industry wide challenge.”

Relevant Drug Shortage News

"At medical institutions across the country, choices about who gets drugs have often been made in ad hoc ways that have resulted in contradictory conclusions, murky ethical reasoning and medically questionable practices, according to interviews with dozens of doctors, hospital officials and government regulators."

“Manufacturers are now required to notify the FDA of impending production disruptions in certain prescription medications. These early notifications give the FDA and manufacturers more time to take actions aimed at preventing disruptions from turning into shortages.” 

Roll Call Op-ed from Former Members of Congress on the Role of GPOs in Mitigating Drug Shortages
“As the health care supply chain continues to search for solutions to the global health crisis of drug shortages, the GPOs will continue to perform a vital service for hospitals and the patients they serve, just as they have in the wake of other recent crises such as Superstorm Sandy.”

Wall Street Journal: U.S. Drug Shortages Frustrate Doctors, Patients
Interviews with company executives, hospital pharmacists and regulators point to several causes of the shortages. Companies have failed to build enough production capacity, haven’t maintained equipment, and failed to ward off contamination in aging plants. A U.S. Food and Drug Administration crackdown on shoddy quality unintentionally worsened the shortages because some companies responded by shutting down plants or scaling back production during renovations."

“As a prominent trade association for purchasing organizations in the United States, HSCA maintains a commitment to helping address the issue of drug shortages and assisting materials managers in navigating them.”

“Saying that GPOs are the primary contributor to such market distortions is like the mall industry calling out bad weather as the cause for spikes in shoplifting.” 

“Isn’t it far more likely that the shortages for certain specialty drugs are a result of them being expensive to manufacture and, based on current reimbursement policy, not very profitable businesses in the first place?”

“In its report, the GAO noted that, of the 168 shortages of controlled substances that were reported from January 2011 through June 2013, nearly 70% began between 2008 and 2013. About half of these were pain relievers and most were generics. As we have noted previously, shortages have sometimes been blamed on FDA enforcement of quality-control problems or manufacturers existing markets.”

Unlike a drug manufacturer or wholesaler, NECC was a compounding pharmacy, licensed only to sell medications to fill individual prescriptions...In other words, it wasn't allowed to market drugs in batches to clinics and doctors--even though that was exactly what it was doing."