FDA Adds 1,000 New Employees During FY 2020
FDA commissioner Stephen Hahn says that over the past year the agency has seen about 1,000 net growth in staff due to a streamlined hiring spree authorized by the recent CURES Act. “For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net gain of 1,027, compared to a FY19 net gain of 135,” he told the Friends of Cancer Research virtual annual meeting 11/13. “We have also made significant progress with the percentage of CURES hires from outside the agency, as 54% of our CURES hires have been external. This represents an important achievement for the agency especially at a time when our focus has rightfully been on the global pandemic.”
Hahn said that despite Covid-19 weighing on resources, FDA’s cancer-related work continues full force. “For instance,” he said, “we are studying closely whether, as some reports have indicated, patients with cancer have worse outcomes than others with Covid-19. One way we’re gathering these (and other) data is with the Covid-19 Evidence Accelerator, run by the Reagan-Udall Foundation and Friends of Cancer Research. Among other research activities, the Accelerator community is applying real world data to help characterize the natural history of patients with cancer and Covid-19, including long-term sequelae, thereby strengthening our science-based response to this unprecedented public health emergency. We are also leveraging our research-based collaborative agreements with several main real-world data companies to support rapid characterization of COVID-19 incidence in cancer populations, as well as its impact on treatment and outcomes.”
Hahn also said the agency is continuing to address the impact the pandemic has had on conducting clinical trials of medical products due to quarantines, infection of participants, site closures, travel limitations, or interruptions to the supply chain for the investigational product. “We are studying and supporting sponsors and trial sites in their work addressing these challenges,” he told the conference. “For instance, we released the FDA Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic and have updated the guidance several times to address inquiries received from stakeholders.”
Additionally, drug approvals have not slowed down due to Covid-19, according to Hahn. As of 10/30, CDER had approved 42 novel drugs, including 15 new drugs to treat patients with various forms of cancer. “Several of these approvals have been ‘firsts’ for oncology, including: The first FDA-approved therapy, Tabrecta (capmatinib), to treat non-small cell lung cancer with specific mutations; Retevmo (selpercatinib), the first therapy approved specifically for lung and thyroid cancer patients with the RET gene alterations; and Tazverik (tazemetostat), the first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer that often occurs in young adults.”