Important steps taken to address generic drug shortages – a problem that has become a national crisis that impacts the U.S. medical community daily.

The last week of October 2019 proved to be an active one on the subject of generic drug shortages and the urgent need to address them. Civica applauds the focus on a problem that impacts the medical community daily and the steps taken by some US government leaders to secure the quality and supply of essential generic medications. Below are three examples of important steps taken and work underway.

     1. The Mitigating Emergency Drug Shortages (MEDS) Act

Civica Rx strongly supports S. 2723, the “Mitigating Emergency Drug Shortages (MEDS) Act,” a recent bill from US Senators Susan Collins and Tina Smith.

Over the past two decades, shortages of generic, injectable drugs critical to the lifesaving work of hospitals in the United States have become commonplace. These drug shortages are so ubiquitous that hospitals and health care systems now maintain permanent drug shortage response teams that seek alternatives to unavailable drugs. As a result, time that hospital pharmacists, technicians, physicians, nurses and others would prefer to spend caring for patients is spent ensuring that the patients who most need short-supply drugs get whatever supply is available.

The typical drug in shortage is a generic, sterile injectable. Many are life-saving products commonly used in surgeries and in emergency rooms at hospitals. Anesthesia medications, antibiotics, pain management medications, nutrition and electrolyte products, and chemotherapy agents have all experienced shortages. Even the sterile saline solution used to administer drugs intravenously has been in short supply.

We fully support and are encouraged by the MEDS Act’s increased FDA authority around disclosures of root causes and expected duration of shortages, extension of reporting requirements for API manufacturers, contingency planning requirements for manufacturers, and incentives for manufacturers to step in to make essential drugs in shortage.

     2. New FDA Report: “Drug Shortages: Root Causes and Potential Solutions”

new report from the FDA on drug shortages identifies root causes of drug shortages including “a lack of incentives to produce less profitable drugs; a lack of recognition for manufacturers that have mature quality management systems; and a more complex and fragmented supply chain that makes it difficult for the market to recover after a disruption.”

We echo Erin Fox, Sr. Director of Drug Information at University of Utah Health, who tweeted, “The report is out! I am so encouraged by the focus on improving quality and transparency for quality.”

A few key takeaways from FDA drug center director Dr. Janet Woodcock, as reported in Inside Health Policy, include:

  • “There’s really a market failure here…even though there’s shortages and there are customers out there who desperately want to get their hands on these medicines, there’s nobody who’s willing to produce them, often, at a price they can offer.”
  • “I don’t know how much this has been contemplated in the efforts by Congress on drug pricing because they’re talking about the higher end,” Woodcock said. “But I do think we’re going to have to make sure we don’t have unintended consequences…and I think some of the shortages actually are unintended consequences of purchasing policies and so forth that people weren’t aware of what was happening on the other end.”
  • The market currently does not recognize or reward manufacturers for having mature quality management systems, Woodcock said. And that’s partially because purchasers have limited information on the quality of manufacturing facilities, and they’re unable to link drug products to specific facilities. “As a result, the market can’t really recognize and reward quality maturity because it’s not really available to them. And therefore, manufacturers are more likely to keep costs down by minimizing investments in this quality because it takes some investment to get to that level of reliability and this eventually then leads to quality problems triggering supply disruption and shortages.” FDA is calling for a system — that could possibly be carried out by the agency — that would measure and rate a facility’s quality management maturity and make that transparent to purchasers.

On a related note, Dr. Janet Woodcock recently authored the following opinion piece in FDA Voices“To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine.”

     3. Congressional Hearing on “Safeguarding Pharmaceutical Supply Chains in a Global Economy”

The Subcommittee on Health of the Committee on Energy and Commerce held a hearing on Wednesday, October 30, 2019. Representative Anna Eshoo facilitated the hearing, which included testimony from the FDA and renowned global supply chain experts.

Representative Eshoo facilitated the meeting and provided an opening statement, part of which is included below:

“There is a hidden health care crisis in this country that will affect us all: the crippling inadequacy of the American drug supply. Today, 90 percent of the medications that Americans take are generics. That’s because they’re cheap, and they’re supposed to be just as safe and effective as expensive brand name drugs. But the generic industry is broken, and it is putting millions of Americans’ health at risk. Our generic drug supply is broken in three devastating ways: shortages of lifesaving medications, subpar manufacturing contaminating our drugs, and an overreliance on foreign production of critical drugs and their ingredients.”

Much of the focus of the session was on concerns about an over-reliance on China for the manufacture of key pharmaceutical ingredients for generic drugs, related drug shortages and possible steps the US can take to secure the supply chain. Read Representative Eshoo’s Opening Statement here. The speakers testifying before the Committee provided written testimony as well (on the Energy and Commerce Committee website). Those testifying included:

  • Janet Woodcock, M.D.: Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Michael Wessel: Commissioner, U.S.-China Economic Security Review Commission
  • Rosemary Gibson: Author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine”

On a related note, Representative Eshoo and Representative Adam Schiff recently co-authored an OpEd in the Washington Post“China’s grip on pharmaceutical drugs is a national security issue.”

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