Senator Josh Hawley (R-MO) is introducing a new bill on Thursday, aimed at protecting the medical product supply chain in light of the coronavirus.
“The coronavirus outbreak in China has highlighted severe and longstanding weaknesses in our medical supply chain. This is more than unfortunate; it’s a danger to public health. Our health officials need to know the extent of our reliance on Chinese production so they can take all necessary action to protect Americans,” said Hawley in a statement.
According to Hawley’s office, The Medical Supply Chain Security Act would:
Require that manufacturers report imminent or forecasted shortages of life-saving or life-sustaining medical devices to the Federal Drug Administration just as they currently do for pharmaceutical drugs. This new information on devices would be added to the FDA’s annual report to Congress on drug shortages.
Allow the FDA to expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.
Give new authority to the FDA to request information from manufacturers of essential drugs or devices regarding all aspects of their manufacturing capacity, including sourcing of component parts, sourcing of active pharmaceutical ingredients, use of any scarce raw materials, and any other details the FDA deems relevant to assess the security of the U.S. medical product supply chain.
“Stronger reporting requirements will help reveal the degree to which our medical product industry is reliant on Chinese production and uncover exactly how vulnerable our medical supply chain really is,” the press release said.
The FDA has warned about the possibility of “potential disruptions to supply or shortages of critical medical products” due to the virus.
"We are keenly aware that the outbreak will likely impact the medical product supply chain," said FDA Commissioner Stephen Hahn in a press release.
The FDA said it is reaching out to drug and device manufacturers in an effort to identify potential disruptions or shortages. Axios reported on Sunday that about 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives —are at risk of a shortage.
Other lawmakers have also raised concerns about the medical supply chain. Rep. Bill Pascrell (D-NJ) and Sen. Bob Menendez (D-NJ) wrote a letter to the FDA earlier this week, asking for more details about how the agency aims to protect the supply chain. The lawmakers said the United States’ reliance on China for drugs and active pharmaceutical ingredients could be a national security risk.
“As the outbreak continues, the risk to the medical supply chain is potentially calamitous due to global dependence on Chinese manufacturing,” Pascrell and Menendez wrote in the letter. “[W]e are concerned about the health and well-being of our own constituents and nation’s ability to access drugs and protective equipment imported from China.”
Howard Sklamberg, a former FDA deputy commissioner, told Yahoo Finance the severity of drug shortage risks depends on how long the outbreak lasts and where it is concentrated.
“Whether the virus becomes a big issue in several countries that are centers of drug production, at the same time,” said Sklamberg.
FDA inspections in China postponed
The FDA stopped inspections at factories in China because of the State Department’s travel warning. The agency said it has other ways to monitor products coming from China, including import screening, testing and records requests. Officials can also stop drugs from entering the United States if they believe they are risky.
“If the coronavirus outbreak goes on longer and in places like China, the shortage risk is a real one, but I do not think that American consumers should be worrying about the safety of the drugs in their medicine cabinet or that they get from the hospital or from doctors,” said Sklamberg.
But the Government Accountability Office has reported “long-standing concerns about FDA’s ability to oversee the increasingly global supply chain.” According to the December report, about 40% of finished drugs and 80% of active drug ingredients are located overseas.
The FDA typically does pre-approval inspections when an entity is applying to supply drugs to the United States, “surveillance inspections” periodically and “for-cause” inspections when there is a suspected problem with a drug. Sklamberg told Yahoo Finance the halt on inspections is not a reason for consumers to panic.
“The system is built on a whole bunch of...mechanisms that prevent problems from occurring,” said Sklamberg. “The fact that there are delays in surveillance inspections —it's not ideal. It's not the way FDA has designed the system to operate, but it also should not be alarming to people.”
Jessica Smith is a reporter for Yahoo Finance based in Washington, D.C. Follow her on Twitter at @JessicaASmith8.