FDA Commissioner Scott Gottlieb speaks in a fireside chat at BIO 2018.
A government shutdown that has dragged on for more than a month and is now the longest in the nation’s history has caused financial hardship for countless federal employees and alarm about increasing risks to public safety and the economy. But more than four dozen organizations are raising another specter: that the Food and Drug Administration will be unable to deliver life-saving therapies to patients.
In an open letter Tuesday to President Donald Trump, Republican Senate Majority Leader Mitch McConnell, Democratic House Speaker Nancy Pelosi and minority leaders Sen. Chuck Schumer and Rep. Kevin McCarthy, 52 groups focused on patient advocacy and medical research implored the officials to reopen the federal government. The shutdown, now at 33 days, is the result of Trump’s refusal to sign a spending bill that does not include $5.7 billion for his proposed wall along the southern border. McConnell has also blocked two House bills to reopen the government.
“On behalf of patients across this country, we are greatly concerned that the agency is currently not fully funded, and thousands of vital FDA employees are not working or able to operate at full capacity,” the letter read. The shutdown, the organizations said, “has begun to put future scientific discovery and innovation in jeopardy.”
Signatories included the American Society of Clinical Oncology, the American Society of Gene & Cell Therapy, the National Organization for Rare Diseases, the National Multiple Sclerosis Society, the National Osteoporosis Foundation and others.
One potential side effect is that new generic drugs will take longer to reach the market, some other groups said. In a statement, Center for Medicine in the Public Interest President Peter Pitts said that could mean hospitals are forced to wait longer to receive them, while the makers of the branded originator products get additional market exclusivity. The group was not among the signatories to the letter.
In a series of tweets, FDA Commissioner Scott Gottlieb detailed how the agency would prioritize activities amid the shutdown. In particular, while at least for some people disruption to FDA services due to the shutdown has been minimal, but the agency can only conduct activities for which user fees have already been paid. However, agency staffers are unable to even respond to emails that do not relate to user fee-funded activities.
The shutdown has affected other agencies that deal with the biotechnology and pharmaceutical industries as well. On Thursday, San Diego-based Gossamer Bio used a legal workaround to go ahead with its initial public offering despite the Securities and Exchange Commission being mostly closed down.
Photo: Alaric DeArment, MedCity News
