Government shutdown threatens drug approvals: 5 things to know

Alia Paavola -

The partial government shutdown soon could impede the FDA's ability to review new drugs, a blow to drugmakers expecting to receive approval of their highly anticipated drugs, according to STAT.

Five things to know:

1. Although the federal agency has retained about half of its workforce during the shutdown because of application fees paid by drugmakers and devicemakers, FDA Commissioner Scott Gottlieb, MD, warns that the agency has only about three more weeks' worth of funding. And, President Donald Trump has warned the government shutdown could last "months or even years."  

2. The FDA was able to review drug applications before the shutdown began but is unable to accept new applications, which means fees are not coming in.

3. More than 10 drugmakers expect the FDA to decide on the efficacy and safety of their products in March. This would be after the FDA ran out of money.

4. As a result, such products as  a potential depression treatment from Janssen Pharmaceuticals; a diabetes drug from Sanofi; and a multiple sclerosis drug from Novartis, would not be able to be reviewed, according to the report.

5. If the shutdown continues, it could also affect drugs slated for approval later this year.

Read the full report here.

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