Dr. Robert Califf on track to be appointed FDA Commissioner

Chip Davis, president and CEO of the Generic Pharmaceutical Association (GPhA), announced this week that Dr. Robert Califf has received enough votes from the Senate Committee on Health, Education Labor and Pensions (HELP) in favor of his nomination as the new commissioner of the Food and Drug Administration (FDA).

If confirmed by the Senate, the new commissioner’s first major decision will involve the pharmaceutical industry, which is waiting for an explanation in regards to biosimilars regulations, Davis said. "We look forward to working with Dr. Califf and the agency to expedite patient access to safe and effective generic drugs and biosimilars,” he said.

Dr. Califf will also have to address the agency’s actions for improvement on the generic drug application backlog. The GPhA will also make efforts to safeguard continued safety standards and maintain a high level of manufacturing procedures. The FDA will provide assistance in ensuring these practices, Davis noted.

Shareholders have also been concerned about the Proposed Rule on generic drug labeling, which is something that Dr. Califf and the FDA will be working with the GPhA to resolve. Another concern that will be addressed is the upkeep of patients’ safety information, Davis said. The FDA and GPhA will work together to keep these documents more up to date to avoid any safety risks in regards to their patients.

Davis said the GPhA are eager to get started in working with Dr. Califf and the FDA to resolve these important issues.