U.S. Food and Drug Administration Commissioner Scott Gottlieb warned drugmakers on the second day of the new year that his agency was able to provide only limited services during the ongoing government shutdown — a closure the Republican head of the Senate signaled could last for weeks.
The FDA furloughed more than 7,000 of its employees on Dec. 22, 2018, or about 41% of its staff, when Congress failed to fund 25% of the U.S. federal government — a shutdown that is now into its second week.
The shutdown comes as a number of drugmakers are waiting to hear from the FDA in next few months on the companies' pending applications. Among those is Alkermes PLC, which is expecting a decision by Jan. 31 on whether it will be permitted to market its experimental medicine to treat major depressive disorder, known as ALKS 5461.
An FDA advisory committee, however, advised against approval at a Nov. 1, 2018, public meeting.
Immunomedics Inc. also is awaiting a decision by Jan. 18 on its application for its experimental drug, known as sacituzumab govitecan, to treat metastatic triple-negative breast cancer.
Among the other companies waiting on approval decisions for new medicines or additional uses of their already approved products in the next couple of months are Merck & Co. Inc., Sanofi, Novartis AG and Novo Nordisk A/S.
The FDA, which approved a record number of new medicines in 2018, declined to tell S&P Global Market Intelligence whether drugmakers should expect the decisions on their pending marketing applications to be delayed.
The agency was able to retain about 59% of its employees using funding and user fees it collects from the industries it regulates that were carried over from the previous fiscal year. But the FDA declined to say how much funding it currently has on hand and how long those funds could carry the agency during the shutdown.
In addition, the FDA and the Department of Health and Human Services declined to say if the food and drug agency would need to soon furlough additional employees beyond the 7,053 who were told to stay home on Dec. 22, 2018, until the shutdown ends.
The FDA is part of HHS, but its appropriations are funneled through the U.S. Department of Agriculture, which is part of the 25% of the federal government whose funding ran out on Dec. 21, 2018.
Currently, about 800,000 of the federal government's employees are furloughed or working without pay.
'As long as it takes'
President Donald Trump on Jan. 2 said he would keep the shuttered agencies closed for "as long as it takes" to get the funding he wants for his proposed border wall between the U.S. and Mexico.
He again demanded Congress provide more than $5 billion for the wall.
After congressional leaders met with Trump, Senate Majority Leader Mitch McConnell, R-Ky., told reporters he was "hopeful" a deal could be reached, though he said it could take weeks.
McConnell acknowledged he did not think any particular progress was made during the Jan. 2 White House meeting with congressional leaders from both parties, though he emphasized it was a "civil discussion."
Rep. Nancy Pelosi, D-Calif., is expected to take the House gavel on Jan. 3 and then lead Democrats in her chamber in passing a legislative package aimed at reopening most of the now-shuttered agencies, funding them through the end of September, the remainder of the fiscal year.
The legislation, however, would fund the Department of Homeland Security only up to Feb. 8 while negotiations continued on border security — a timeline the Republican-controlled Senate had initially agreed on for the 25% of the government that is closed.
McConnell, however, said he would not bring the Democrats' legislation to the Senate floor for a vote because Trump said he would not sign it.
Tweets and memos
In a Dec. 31, 2018, memo to employees, Gottlieb said he knew the lapse in appropriations funding "creates personal uncertainty for many of you, and private hardships."
Ahead of the shutdown, the commissioner told his staff "I deeply regret that we face these challenges."
One FDA worker told CBS News he was having to resort to donating his blood plasma to make ends meet during the shutdown.
On the FDA's jobs website, the first thing prospective employees currently see is a notice about the agency's lapse in funding, which could harm its recruiting efforts.
Throughout the shutdown, Gottlieb has been communicating with employees, industry and the public mostly through Twitter.
In a series of late-evening tweets on Jan. 2, Gottlieb said the lapse in FDA funding would "limit many medical product related activities," including the development of certain guidelines.
During the shutdown, regulators cannot accept new applications for medical products — new drugs, medical devices and biologic therapies — that require the payment of a user fee because the FDA is not allowed to accept those fees without Congress passing appropriations for the agency, the commissioner said.
The FDA, however, can accept new regulatory submissions for which no fee is required for new drugs and biologic medicines, including those that fall within the fee exemption for previously filed applications, Gottlieb said.
The FDA chief said he would provide additional information on Jan. 3 on how the shutdown is expected to affect applications for generic drugs and biosimilars — medicines intended to be lower-cost versions of biologic therapies.