On Saturday, the ongoing government shutdown broke the record for the longest halt in federal government activity in US history as it hit the 22-day mark. With no end in sight, and stories of economic hardship among federal workers already piling up, the head of the Food and Drug Administration offered an update on how the regulatory agency is faring.
“The lapse in funding represents one of the most significant operational challenges in FDA’s recent history,” Commissioner Scott Gottlieb tweeted Sunday morning. Gottlieb nevertheless wrote that the agency would expand its activities beyond what it has done during previous shutdowns. With regard to drugs, this includes expanded inspection beyond “for-cause” inspects to include foreign and domestic drug, device and pharmacy compounding surveillance inspections; surveillance sampling of imported high-risk medical products; and expanded surveillance and response for product recalls.
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“It is not business as usual at FDA,” Gottlieb wrote. “Many key functions aren’t getting done. But we’re focused on maintaining core activities that directly impact consumer safety and save lives.”
The shutdown – which has forced about 800,000 federal workers to be furloughed or work without pay – is due to President Donald Trump refusing to approve a budget unless it includes $5.7 billion for a wall along the US-Mexican border.
So far, for at least some drugmakers, the shutdown has had a limited effect in terms of their routine interactions with the FDA. “From our standpoint, disruption has been minimal,” said Matthew Weinberg, CEO of Washington-based biopharma regulatory consultancy The Weinberg Group, in a phone interview. The FDA project managers with whom his firm interacts have been responsive, and meeting requests have been accepted. However, he added that the firm has not yet tried to submit an Investigational New Drug application – used to seek agency approval to begin a clinical trial – during the shutdown. In addition, it is with clients that have already paid user fees to the FDA that the agency is continuing to work.
“Due to the absence of an FY 2019 appropriation or continuing resolution for FDA, I am unable to respond to non-user fee-related messages,” Weinberg said, quoting an email from an FDA project manager he declined to name. The consultancy has not tried to submit any items for which user fees have not been paid to the agency.
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“I think the people at the FDA work hard and do the best they can,” Weinberg said. “I’m sure this is a trying time for everyone. I’m sure there are people working who aren’t getting paid – we need to be cognizant of that before wondering why they aren’t doing more.”
Still, the longer the shutdown goes on, Weinberg added, the more likely it is that drugmakers’ timetables and drug development generally will face disruption. Last week, experts explained to NBC News that a prolonged shutdown lasting “months or years” – as the president has suggested – would also mean that companies looking to make initial public offerings would be stuck in limbo. Given that biopharma companies often have to go public long before having a product on the market in order to raise sufficient capital for clinical and even preclinical development, that would be especially problematic for the sector.
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