President Obama nominates Dr Robert Califf as new FDA head
pharmafile | September 16, 2015 | Appointment | Manufacturing and Production, Medical Communications |
US President Barack Obama has put forward Dr Robert Califf as the next commissioner of the FDA, according to a White House statement.
Dr Califf has been serving as the FDA’s deputy commissioner for medical products and tobacco since January, following the departure of former commissioner Dr Margaret Hamburg, who stepped down in March after one of the longest contemporary tenures for an FDA commissioner, at nearly six years. FDA scientist Dr Stephen Ostroff has been serving as the interim commissioner since Hamburg’s departure.
Califf has strong medical and regulatory credentials, as the former vice chancellor of Duke University’s School of Medicine and a professor of cardiology and medicine at the school.
Califf is being nominated to the top spot at the FDA during a time of critical change, when the Agency is pushing through reforms designed to make the US regulator more aggressive when looking to approve orphan drugs and treatments for patients with unmet medical needs.
The US Congress is expecting Senate approval for the 21st Century Cures Act in the coming months. The major FDA reform bill is intended to further expedite drug development, involve patient voices in the regulatory process more, make it easier for companies to communicate the economic value of drugs, and encourage transparency in payments to doctors.
Commenting on the announcement to nominate Dr Califf, along with several other senior Government posts, President Obama said: “I am confident that these experienced and hardworking individuals will help us tackle the important challenges facing America, and I am grateful for their service. I look forward to working with them.”
