Dive Brief:

• AdvaMed has called for a renewed effort to sustain and strengthen COVID-19 test manufacturing after the White House warned it only has funding to maintain capacity through June. 
• The White House warning that Congress risks "squandering" capacity built up through targeted federal investments added urgency to AdvaMed's reply to a HHS request for information about how to preserve and expand testing capacity.
• AdvaMed is calling for the creation of a permanent public-private diagnostic testing forum, more funding for the strategic national stockpile, warm-base manufacturing agreements and increased investment in the Biomedical Advanced Research and Development Authority.

Dive Insight:

Last month, HHS put out a request for information about how to sustain the "testing and manufacturing capacities that have been established domestically over the last 12 months [to] prevent capacity loss due to market volatility." The comment period closed on Wednesday.

On Tuesday, a senior administration official set out the need to sustain the current capacity in a White House press call.

"Without additional funding, we do not have the ability to maintain our domestic testing capacity beyond June. So, after spending the last year building up our testing capacity, Congress now risks squandering that capacity heading into the second half of this year. And because it takes months of ramp-up to rebuild capacity, failure to invest now will leave us less prepared for any potential future surges," the official said, speaking on background. "So, providing funding only when cases rise is far too late to make a difference. Bottom line: We need funding now so we're prepared for whatever comes next."

The concerns, which the White House reiterated in a fact sheet, form the backdrop for the HHS request for information that spurred AdvaMed to describe the actions it thinks will help sustain capacity in its 13-page response to the executive branch department.

AdvaMed's list of recommendations is topped by the creation of a permanent public-private diagnostic testing forum.

The trade group envisages the forum improving short- and long-term preparedness for public health emergencies through "heightened, regular, data-driven coordination" between public and private players to inform a policy "to sustain bolstered manufacturing capacity and lab capacity, as drops in demand occur, in between spikes of increased need for testing."

As AdvaMed sees it, the presence of such a forum could have ensured rapid antigen test capacity was maintained in the summer of 2021, when demand fell sharply, avoiding the shortages the U.S. faced when cases surged later in the year. AdvaMed called for warm-base manufacturing contracts that summer but, lacking a public-private forum, failed to persuade the government to act. 

AdvaMed used the reply it submitted to HHS this week to reiterate its call for warm-base manufacturing.

The group wants the federal government "to contract with diagnostic manufacturers that have invested in expanded capacity during the COVID-19 pandemic to sustain these increased manufacturing levels," adding that contracts "might also include provisions to support the development, manufacturing, and deployment of diagnostics not already available on the commercial market." 

The lobby wants the government to rapidly issue requests for 12 to 24 month warm-base manufacturing agreements that enable companies to ramp up capacity to meet peak demand in 60 to 90 days. That would enable the government to trigger the clause upon the detection of a threat and have sufficient testing capacity in place far faster than happened at the start of the COVID-19 pandemic.

President Joe Biden set out a plan for dealing with future surges of COVID-19 earlier this month. However, Congress needs to agree to provide additional funding if the White House is to enact the strategy.