Reliance on Drug Imports, Coronavirus Supply Chain Concerns Raised in House Hearing

Regulatory NewsRegulatory News
| 27 February 2020 | By Michael Mezher 

The prospect of pharmaceutical supply disruptions caused by the ongoing coronavirus (COVID-19) outbreak, as well as concerns with the US Food and Drug Administration’s (FDA) oversight of foreign drug manufacturing, were raised by representatives during a House Appropriations subcommittee hearing Thursday.
Suzanne Murrin, deputy inspector general for evaluation and inspections at the Department of Health and Human Services Office of Inspector General, fielded questions from representatives on her office’s oversight of FDA, with some representatives demanding answers about drug safety and supply chain security in light of the impact the coronavirus outbreak has had on China.
Ranking Member Jeff Fortenberry (R-NE) grilled Murrin over FDA’s oversight of foreign drug manufacturers and said the coronavirus outbreak highlights the risks of the US dependence on imports, noting that about 40% of finished drugs and 80% of active pharmaceutical ingredients are made in other countries.
“This is all the more urgent given the outbreak of the coronavirus, this has extenuated the need to produce critical drugs and medical supplies right here,” Fortenberry said.
Fortenberry also pointed to a recent preliminary report from the Government Accountability Office (GAO) on FDA’s foreign inspections program that found that most foreign inspections are preannounced, in some cases up to 12 weeks in advance, giving foreign manufacturers more time to prepare for inspections than domestic manufacturers who are subject to unannounced inspections.
Murrin said she would get back to the committee with responses to those issues and pointed out that OIG is currently reviewing FDA’s foreign inspection process and is developing an oversight plan for HHS’ coronavirus response.
Murrin noted that FDA has taken steps to improve its foreign inspection processes since the OIG’s 2015 report. “In response to our work, FDA resolved all 289 outstanding preapproval inspections of generic drug manufacturers, most of which were for foreign manufacturers,” she said.
Medical Devices
Murrin added that one of OIG’s biggest concerns is the cybersecurity of networked devices, such as infusion pumps and pacemakers.
“Without appropriate security controls, these devices can be susceptible to cybersecurity threats such as ransomware and unauthorized remote access,” she said, adding that FDA is “working in the right direction” in its implementation of pre- and postmarket cybersecurity guidance.
Murrin also said that OIG would recommend that FDA “establish procedures for securely sharing information about cybersecurity threats to key stakeholders.”


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