Hahn Takes Heat in Hearing on Coronavirus
FDA commissioner Stephen Hahn was criticized during a House Appropriations subcommittee hearing 3/11 about delays in coordinating laboratory-developed tests amid the coronavirus outbreak. Subcommittee chair Sanford Bishop (D-GA) said he was worried about Hahn and the Trump Administration’s “confusing and inaccurate predictions” about how many coronavirus tests would be available in the U.S. (see earlier story).
Hahn said FDA began reaching out to its lab partners in January before any virus case had been detected in the U.S to encourage test development and to lend assistance to test developers. He said the agency has worked with over 100 developers to date on diagnostic tests using a template it provided.
While responding to Bishop’s concerns, Hahn did not address any delay in putting in place a new policy 2/29 to permit certain laboratories to use tests they develop and validate (see story). Many critics have questioned why it took so long to put the policy in place. The policy, which dramatically improved the testing capacity, permits certain laboratories to use validated diagnostics before the agency has completed the review of their Emergency Use Authorization requests.
During questioning, Hahn stated that there have been 2.5 million tests distributed throughout the U.S. that could assess almost 1 million patients. However, Rep. Mark Pocan (D-WI) noted that recent information from former FDA commissioner Scott Gottlieb indicates that test processing limitations have led to only 16,000 tests being run per day, and it may reach 20,000 per day by the end of the week. Hahn, who is part of the Trump Administration’s coronavirus task force, had to admit he did not know the actual number of tests being run each day.
If Gottlieb’s numbers are in line, an irritated Pocan said, “then that is a real problem.” He criticized the task force for touting the numbers of tests being shipped without disclosing that limitations permit only a fraction of the tests to be performed. “The problem is people believe that they are not being told the total truth,” he said, adding that it was frustrating that the number of tests performed could not be recited by Hahn. Asked if reports are true that shortages are occurring with reagents used in the testing, Hahn said he was aware of pressure on the supply system with reagents and FDA’s shortage group is working to identify alternative reagents.
Ranking member Robert Aderholt (R-AL) expressed concern with the U.S. drug supply, which may be at risk when many of the drugs in the U.S. are sourced from over 150 countries. Hahn assured the subcommittee that the drug supply is safe and secure. He said it would be wise to look at the issues of redundancy in manufacturing. “We have to do whatever we can to stimulate advanced manufacturing with pharmaceuticals and to encourage domestic production. I think that will give us the appropriate redundancy and allow us to ramp up when we need to for essential medications and vaccines.” Hahn also said FDA lacks full and robust information about the medical product supply chain. “We have number of legislative proposals in the drug, device and animal drugs sphere that would give us additional information to help keep an accurate track of the supply chain,” he said.