Drug Shortages Act Needed As Coronavirus Threats Grow

Legislation recently introduced in the US House of Representatives will help curb drug shortages, particularly in light of potential COVID-19 supply chain issues.

The Preventing Drug Shortages Act (H.R. 6080) was introduced by a group of Congressional representatives on March 5.1 It would help mitigate shortage triggers by enhancing transparency throughout the drug supply chain process and strengthening FDA interagency efforts to fend off drug shortages, US Representative Richard Hudson (R-NC) said in a press release.2

The bill would also empower the FDA to enforce greater reporting standards on drug and active pharmaceutical ingredient makers to identify and correct vulnerabilities in their supply chains.

“Drug shortages under normal circumstances result in significant strain throughout our healthcare system-from patients to hospitals and physicians,” said Rep. Scott Peters (D-CA).2 “Unfortunately, the health emergency presented by COVID-19 is exacerbating these problems and we are already beginning to experience its adverse reactions on global drug supply chains.”

FDA recently confirmed the first drug shortage related to manufacturing delays in China due to COVID-19.

“The coronavirus outbreak has demonstrated how susceptible our nation’s drug supply chain is to disruptions that could have devastating impacts on our public health because of our overreliance on China for generic drugs. The coronavirus has already caused 1 shortage and it’s unclear if there are more to come,” Rep. Anna Eshoo (D-CA) said.2

“We are pleased to see members of the House of Representatives take steps to address the critical shortages of vital, life-saving medications jeopardizing patient care in the United States,” said Tom Kraus, JD, vice president of government relations for ASHP in a press release.3 “Pharmacists and other health care providers struggle to obtain reliable supplies of essential medications, resulting in delay or prevention of treatment, serious harm to patients, and unnecessary costs to our health care system.”

Although ASHP has been working on drug shortage prevention initiatives for years, the legislation is particularly timely “as the rise of COVID-19 shines a light on the dangerous implications the lack of transparency in the drug supply chain has on our health care system,” ASHP said.3

The new legislation reflects key elements of several of the recommendations to address drug shortages that ASHP previously made with the American Society of Anesthesiologists, the American Hospital Association, and the American Society of Clinical Oncology.

References:

1. Rep. Peters, Scott H. [D-CA-52]. H.R. 6080 – Preventing Drug Shortages Act. March 4, 2020. https://www.congress.gov/bill/116th-congress/house-bill/6080

2. Hudson Introduces Preventing Drug Shortages Act in Wake of Coronavirus [news release]. Congressman Richard Hudson’s website. https://hudson.house.gov/press-releases/hudson-introduces-preventing-drug-shortages-act-in-wake-of-coronavirus/#dialog.

3. ASHP Statement on the Preventing Drug Shortages Act [news release]. ASHP’s website. https://www.ashp.org/News/2020/03/05/ASHP-STATEMENT-ON-THE-PREVENTING-DRUG-SHORTAGES-ACT.