The act aims to mitigate common triggers of drug shortages by improving transparency throughout the drug supply chain process, and strengthening FDA interagency efforts to prevent shortages.
As health care providers become increasingly concerned by the potential effects of the novel coronavirus (COVID-19) on drug supplies, several members of the House of Representatives have introduced the bipartisan Preventing Drug Shortages Act.
The act aims to mitigate common triggers of drug shortages by improving transparency throughout the drug supply chain process, and strengthening FDA interagency efforts to prevent shortages. The bill would also give the FDA the power to enforce greater reporting standards on drug and active pharmaceutical ingredient manufacturers, in order to identify and correct vulnerabilities in their supply chains.1
“While we may never be able to predict or fully prevent the challenges posed by situations like the coronavirus outbreak, Congress should take steps to fortify drug supply chains,” said Rep. Scott Peters (D-CA), a sponsor of the bill, in a prepared statement.1
Drug shortages have become increasingly common in recent years, according to a statement from Peters, and outbreaks such as COVID-19 or natural disasters place increasing pressures on supply chains. Peters added that over-reliance on foreign pharmaceutical products is a concern in the battle to minimize drug shortages,1 an issue that has been brought to the forefront as COVID-19 impacts manufacturers in China.
“Many of our critical medications are sources from China and India, said Rep. Eliot Engel (D-NY), another sponsor of the article. “The growing outbreaks in these countries, and the first reported coronavirus-related drug shortage underscore the need to protect and secure our drug supply chain needs.”1
Several organizations have expressed support for the legislation. Premier Inc, a health system and medical provider alliance, released a statement saying the bill will help close gaps that endanger patients’ lives.2
“By requiring manufacturers of active pharmaceutical ingredients and raw materials to notify the [FDA] Food and Drug Administration of supply disruptions, the bill will also institute an early warning system allowing upstream visibility to potential shortages that can be actioned proactively,” the statement said.2
The American Society of Health-System Pharmacists (ASHP) also released a statement praising the bill’s sponsors for addressing drug shortages.
“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 ASHP Vice President of Government Relations Tom Kraus, JD, in the statement. “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.”3
The bill has been referred to the House Committee on Energy and Commerce.4