- July 07, 2020
In an interview on the Device Talks Weekly podcast, Whitaker laid out steps he believes the federal government and med-tech industry must take, including addressing medical device and supply stockpiles and strengthening supply chains. Above all, Whitaker said, any response is strongest when government and industry work together, a lesson learned early on when the U.S. Centers for Disease Control and Prevention (CDC) attempted to roll out the first line of COVID-19 diagnostic tests.
Critics of the Trump administration’s handling of the pandemic have pointed to the failure to roll out a diagnostic test early enough to slow the spread of the virus that has killed over 70,000 people in the US. “One of the biggest mistakes or flaws was early on when the CDC sort of fumbled that first task,” Whitaker said. “That was not the private sector that bungled it. There were not mistakes made by the private-sector companies. There were mistakes made by career officials at CDC. And it’s not to criticize, it’s just to recognize the reality that it takes both of us be successful. You’re not going to solve a crisis or be prepared for a crisis if it’s government-owned,” Whitaker added. “It’s just not going to happen.”
The trade group leader gave the Medtech industry high marks for its response to demands for critical medical equipment, calling it “frankly excellent.” Early reports of the pandemic certainly suggested ventilator and protective personal equipment supply could be a problem, but no one could anticipate the actual demand. “I wouldn’t say at the beginning of this year I knew it was going to be this acute,” Whitaker said. “You got the sense in February [and early March] … that we were getting ready to get hit with something that could be potentially catastrophic.”
Efforts to meet that demand led to the Trump administration invoking the Defense Production Act (DPA). Whitaker said he was initially concerned that the government would use the act to take control of factories. However, those fears have been unfounded so far and Whitaker credited the administration for using the DPA to make critical ventilator parts a higher-priority import. “It allowed those products to get into the country more quickly and not get held up at ports of entry,” he said. “So that was a very good use of the DPA. My assessment now is they used it appropriately, but it’s still in place. This is not over. And I think we need to make sure we’re continuing that dialogue, so it’s not used in the wrong way.”
Asked to assess the federal government’s response, Whitaker — who worked on pandemic preparation as Chief of Staff for the U.S. Department of Health and Human Services (DHHS) under President George W. Bush — said he does not tend to “look back and criticize, particularly in the middle of a crisis, but I’m not sure the U.S. government or any other government for that matter can be fully prepared for a pandemic with a novel virus. And that was the case here.”
“I think the honest answer is, we weren’t fully ready for it,” he said.
Whitaker added that he puts more weight on pandemic response than on preparation, and he credited the federal government with engaging with industry to meet the needs created by the pandemic. He specifically mentioned the FDA’s quick work to issue emergency use authorizations (EUAs) for devices and diagnostics and said AdvaMed will seek clarification on how EUAs will be considered after the crisis is over.
REFERENCE: Mass Device; 06 MAY 2020; Tom Salemi