Facing a worldwide outbreak of the new coronavirus, the Academy worked with members of the House of Representatives to introduce legislation this week to protect our nation’s drug supplies.
The Preventing Drug Shortages Act would promote efforts to secure the drug supply chain and increase transparency from manufacturers on the cause and expected duration of shortages.
Eight lawmakers introduced the bipartisan bill: Rep. Scott Peters, D-Calif., Rep. Eliot Engel, D-N.Y., Rep. Brett Guthrie, R-Ky., Rep. Anna G. Eshoo, D-Calif., Rep. Richard Hudson, R-N.C., Rep. Michael McCaul, R-Texas, Rep. Kurt Schrader, D-Ore., and Rep. Gus Bilirakis, R-Fla.
Our support for this and for another Senate bill addressing drug shortage crises are vital in the Academy’s prioritized advocacy efforts to address ongoing drug shortages affecting ophthalmology practices.
The Academy last week also joined 13 hospital, pharmaceutical and other health organizations in a letter to Sen. Lamar Alexander, R-Tenn., chairman of the Committee on Health, Education, Labor, and Pensions, and ranking member Sen. Patty Murray, D-Wash, requesting quick passage of the Mitigating Emergency Drug Shortages (MEDS) Act. Introduced last year before the coronavirus outbreak, the bill is gaining momentum as the virus threatens overseas supplies used in drug manufacturing from China and other Asian factories affected by the outbreak.
Shortly before introducing the House bill, Reps. Hudson and Eshoo echoed the Academy’s concerns.
“Too often I’ve heard from constituents and providers that access to lifesaving drugs has been interrupted because of a drug shortage,” Hudson said. “We cannot let this continue to happen, especially as new threats like coronavirus emerge.”
“This legislation takes some first steps to increase what information the federal government needs to receive from drug manufacturers about ongoing shortages and requires manufacturers to have risk management plans to mitigate the impact of drug shortages that affect the American people,” Eshoo said.
To minimize that risk, the Academy wants drug manufacturers to report potential supply disruptions to the Food and Drug Administration, and we want the Department of Health and Human Services to step up monitoring of the nation’s drug supplies.
Manufacturers of active pharmaceutical ingredients currently do not have to report disruptions in supplies to the FDA, and many U.S. companies that buy those ingredients purchase them China, where information is scarce about when factories will resume normal production.
The Senate bill also would strengthen the Health and Human Services’ oversight to protect the nation’s drug supply chain by requiring that the agency issue recommendations on greater domestic manufacturing of finished dose formulations and active pharmaceutical ingredients.
As of March 5, the number of COVID-19 cases around the world was closing in on 100,000, with more than 3,300 deaths, including 11 in the United States. U.S. health experts believe that number will grow exponentially as it has in other countries.
Creating a system to monitor the nation’s drug supplies would give the U.S. “an early warning system that would allow the FDA upstream visibility to appropriately assess risk” for outbreaks of diseases like the coronavirus and for other natural disasters, such as Hurricane Maria, according to the letter sent to the Senate.
Only last week, in light of the coronavirus outbreak, FDA officials announced the agency had contacted more than 180 drug manufacturers about their supplies and stepped up its monitoring of the drug supply chain.
What the Academy is doing
- Alert on coronavirus: See daily updates to our alert on coronavirus. Stay on top of the latest news, journal articles and health care alerts, including updates from the Centers for Disease Control and Prevention and the World Health Organization.
- The Academy will keep its business offices open to create resources and alerts that will help your practice answer questions about the outbreak. In an address this week to staff, Academy CEO David W. Parke II, MD, said we’re making sure the Academy is responsive through any coronavirus outbreak in the U.S. “We’re in this for the long haul,” he said.