HENRICO, V.A. –  U.S. Representative Abigail Spanberger is calling on the U.S. Food and Drug Administration (FDA) to answer pressing questions about the potentially life-threatening consequences of ongoing drug shortages across the country.

The number of drug shortages in the United States continues to rise. According to a recent study, U.S. healthcare providers experienced 186 new drug shortages in 2018—a 27 percent increase from 2017 and the highest amount of shortages in the previous five years. These shortages can lead to delays in patient treatment, decreased quality of patient care, and increased operations costs at U.S. hospitals and pharmacies.

In June 2018, the American Medical Association declared drug shortages a public health crisis. Following this announcement, the FDA established the Agency Drug Shortages Task Force to identify the root causes of these drug shortages and to recommend potential solutions in a report to Members of Congress. However, this report has not yet been submitted to Congress. In a letter sent to Acting FDA Commissioner Norman “Ned” Sharpless this week, Spanberger and a bipartisan group of her colleagues reaffirmed that addressing drug shortages is a priority for Members of Congress—and they asked for the release date of the Task Force’s report.

“While we appreciate the ongoing efforts of the Food and Drug Administration to prevent these shortages, it is imperative that FDA balance shortage prevention programs with similar efforts to respond expeditiously to new shortages,” the letter states. “This is especially important given the number of factors that can contribute to drug shortages, ranging from environmental disasters to issues with manufacturing quality standards. We recognize that many shortages require case-specific solutions, which require the agency to be flexible in its response.”

“We would appreciate FDA’s prompt response to this inquiry,” the letter continues. “In addition, we ask that FDA include in its response the date when the Drug Shortages Task Force will submit its report to Congress.”

Drug shortages of critical medicines such as epinephrine and ketamine can significantly hinder the delivery of high-quality patient care. A disruption in the regular supply of drugs threatens patients and can lead to:

• Substitution of suggested treatments with alternatives therapies,
• Compromised or delayed medical procedures, and
• Rationing of prescription drug doses.

The bipartisan letter was led by U.S. Representatives Eliot Engel (D-NY-16) and Brett Guthrie (R-KY-02) and signed by Spanberger and 89 additional House Members. The Spanberger-signed letter has been endorsed by the American Hospital Association, the American Society of Health-System Pharmacists, the American Society of Clinical Oncology, and the American Society of Anesthesiologists.

Click here to read the full letter.

BACKGROUND

Last month, Spanberger met with Central Virginia families, patients, providers, and pharmacists to learn more about the challenges caused by overpriced prescription drugs in Henrico County and to discuss potential legislative solutions to the drug affordability crisis

 

Spanberger has long fought to expand access to affordable healthcare coverage and prescription drugs for all Central Virginians. Earlier this year, Spanberger introduced and led a bipartisan bill to hold pharmacy benefit managers accountable. In April, this legislation passed unanimously out of the House Ways and Means Committee, and the bill passed out of the House Energy and Commerce Committee in July.

Earlier this year, she also joined a majority of the U.S. House in passing a bipartisan bill she cosponsored that would make it easier for Central Virginians to access lower-cost prescription drugs. The bill would prohibit pharmaceutical companies from participating in certain anti-competitive practices that block cheaper generic drugs from entering that market.

And in January, she helped introduce the Medicare Negotiation and Competitive Licensing Act, which would authorize the U.S. Department of Health and Human Services to negotiate directly with pharmaceutical providers within Medicare Part D to help lower costs.

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