President Barack Obama announced Tuesday that he would be recommending Dr. Robert Califf – a prominent cardiologist and researcher – as the next commissioner of the US Food and Drug Administration (FDA). The nomination is no surprise to insiders, who expected the announcement following Califf’s appointment as deputy commissioner in January.
Though Califf must await the Senate’s decision, those in the industry do not anticipate he will face much opposition. According to Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, “He’s widely respected by the medical community and represents a terrific choice to lead the FDA. He has good ideas but he doesn’t run over people with them. He will get along well with Congress.”
The announcement comes at a time when the FDA is facing more pressure than ever. Public advocacy groups are urging the agency to better regulate e-cigarettes, while the US Congress stresses the FDA to speed up new drug approval times.
In addition, the administration is working on regulating the ever-growing biosimilars market, as well as instating new rule governing food safety. Following his instatement at deputy commissioner for medical products and tobacco in January, Califf told reporters that he wanted to focus on streamlining the clinical trial process.
This objective was welcomed by everyone involved in the process of bring a new pharmaceutical to market. Countless lawmakers are currently backing bills in Congress aimed at speeding up the drug approval process.
A bill known as the 21st Century Cures Act has already been passed by the US House of Representatives, with a similar bill currently being considered in the Senate. The act would require the FDA to make a number of changes to its new drug review process, including the consideration of more varied forms of clinical trials, and using patient experience information to evaluate the drug.
Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research comments, “This is the right choice at the right time for a complex agency that impacts all Americans.”
A former colleague of Califf, Dr. Nancy Andrews, dean of the School of Medicine at Duke University, said that he’s data-focused when it comes to making decisions. She said, “He cares a lot about patients getting the right dose of the right medicine and not taking things that don’t help them.”
Califf comes with an impressive resume; he’s published over 1,000 research papers, and has run numerous clinical trials. Former commissioner Dr. Margaret Hamburg, served as head of the FDA for nearly six years before stepping down in March of this year.
Current acting commissioner Dr. Stephen Ostroff, will be replaced by Califf as long as he receives Senate approval. Califf’s previous position was as the vice chancellor of clinical and translational research at Duke University, where he emphasized the translation of scientific advances into applied medical care.
- Obama nominates Robert Califf as FDA commissioner – http://www.reuters.com/article/2015/09/15/us-fda-commissioner-califf-idUSKCN0RF2JX20150915