FDA, Drugmakers Continue Work to End Critical Drug Shortages

Kerry Dooley Young

June 22, 2018

The US Food and Drug Administration (FDA) this week issued a statement about its efforts to address shortages of intravenous fluids, injectable opioids, and EpiPen epinephrine shots (Mylan). The agency said it has expedited reviews of applications from makers of saline to try to add capacity and additional supply. The FDA said it is also working closely with the maker of the EpiPen epinephrine shot and producers of injectable analgesics.

In recent years, the FDA has worked more closely with drugmakers in an attempt to avoid shortages. The number of new shortages tracked by the FDA's drug divisions has decreased to 39 for 2017, from a peak of 251 in 2011. But even with these advances, physicians and pharmacists still have to scramble to find workarounds for a shortfall of saline and inadequate supply of other crucial treatments.

In the meantime, medical groups and lawmakers are calling for a broad effort to tackle the underlying causes of chronic shortages of critical medicines in the United States.

"Over the last decade, hospitals and health systems have experienced shortages of widely used critical medical products," Roslyne Schulman, director of policy at the American Hospital Association (AHA), told Medscape Medical News in a statement.

"While we have appreciated the efforts of the FDA to help alleviate the recent shortages, more needs to be done because acute and chronic drug shortages impact patient care, hospital operations, and the ability to continue to provide the highest quality of care possible," Shulman said. 

The AHA joined other medical groups last year in offering a set of recommendations to address the drug shortages. Their suggestions included having the Federal Trade Commission consider the risk of altering or disrupting the manufacturing of critical medicines due to pharmaceutical mergers and acquisitions. The recommendations were also supported by the American Society of Clinical Oncology, the American Society of Anesthesiologists, and the American Society of Health-System Pharmacists (ASHP).

These medical groups also have suggested that Congress should require the Department of Health and Human Services and the Department of Homeland Security (DHS) to identify ways that they can support manufacturers of critical products. In a 2017 report, the groups suggested "exploring funding opportunities to support the continued flow of products needed during emergency situations."

Creating new funding opportunities almost certainly would require new legislation. Lawmakers in both parties appear to be setting the stage for future work on drug shortages. On June 15, a bipartisan group of senators asked FDA Commissioner Scott Gottlieb to convene a taskforce to examine the "root causes" of drug shortages.

The taskforce should submit recommendations to Congress by the end of 2019, said Senators Chris Murphy (D-CT) and Bill Cassidy, MD (R-LA), and more than 20 colleagues, including Senator Rand Paul, MD (R-KY), in the letter to Gottlieb.

"We appreciate the work of the agency to mitigate the impact of shortages created in the wake of Hurricane Maria and recent shortages resulting from manufacturing deficiencies," the senators write. "However, drug shortages continue to present consistent, frequent, and significant risks for patients and threaten the stability of our health care system."

Business Case

A noted researcher on drug shortages has argued that the solutions to this issue rest in business at least as much they do in regulation.

"To everyone yelling at FDA to fix this — it's really the drug companies that need to get their houses in order," tweeted Erin Fox, PharmD, from the University of Utah, Salt Lake City, on June 21. "FDA can't make any company make anything — no matter how life saving or critical."

In an April article in the New England Journal of Medicine, Fox proposed creating financial incentives, such as  tax relief for facility repairs, to keep companies interested in making the kinds of drugs often subject to shortages.

These shortages frequently occur with older, generic, injectable medications, which are produced by a only small number of suppliers. Fox also suggested that DHS "mandate that saline be considered part of the essential infrastructure, which would require the relevant companies to develop business continuity plans."

For now, though, physicians and pharmacists must try to marshal limited supplies of critical medicines, such as the EpiPen epinephrine shots.

"When you consider the dangers of anaphylaxis, epinephrine supply issues are always extremely concerning for patients who have severe allergies, their families, and the physicians who care for them," Robert A. Wood, MD, president of the American Academy of Allergy, Asthma & Immunology, told Medscape Medical News in a statement. "Delaying epinephrine administration could be the difference between life and death."

The FDA has reminded physicians, pharmacists, and patients that there are alternative epinephrine products that can be used safely, while also detailing the response of Mylan, the maker of the EpiPen product, to the shortage.

"Based on Mylan's information, the FDA anticipates the issue to be short-term," said Douglas Throckmorton, MD, deputy center director for regulatory programs in the agency's Center for Drug Evaluation and Research, in a blog post.

The FDA also is keeping in "constant communication" with Pfizer as it addresses issues involved at a Kansas plant that led to a shortage of injectable opioid analgesics, Throckmorton said.

"While Pfizer currently expects that delays will continue until 2019, we are working with them to increase supplies before then," he writes. "Pfizer recently coordinated with the agency to release some of the products that were on hold due to potential quality issues to distribute them with instructions for the safe handling and use to help mitigate any risks to patients."

The FDA has also worked with Akorn Pharmaceuticals, Fresenius Kabi USA, and West-Ward Pharmaceuticals in their efforts to increase production of injectable analgesics.

"However, it is taking time for these companies to produce enough product to cover the shortfall in the market," Throckmorton said. "We will continue to share updates on our website as this situation progresses."

With saline, the 2017 hurricane that devastated Puerto Rico worsened an existing shortage, Throckmorton said. FDA assisted Baxter in its effort to raise its production of saline products, while also expediting reviews of other companies' applications and supplements to add capacity and additional supply, he said.

Jillanne M. Schulte Wall, JD, director of federal regulatory affairs for the ASHP, noted the limits of the FDA's ability to resolve drug shortages.

"While we're happy that more product is making its way into the market, we share FDA's belief that there's still much more work to be done to get to the end goal — a continuous supply chain where shortages are thing of the past," she told Medscape Medical News.  "ASHP is continuing to advocate for changes that move this goal closer to reality."

More information about the FDA's efforts is available on the agency's website.

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