FDA Drug Expert Ellis Unger Joins Law Firm
Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has joined Hyman, Phelps & McNamara as a principal drug regulatory expert. After 24 years at FDA, Unger retired from the agency last year to spend more time with family. He joined FDA in 1997 as a medical officer at CBER, and in 2003 transitioned to CDER when regulatory authority for therapeutic biologics was transferred there and he began serving as Division of Cardiovascular and Renal Products deputy director. In 2009, Unger moved to the Office of Drug Evaluation-I in 2009.
In his new role, Unger will “assist companies on a multitude of drug and biological product legal, regulatory, and policy issues,” the law firm said. “His experience at FDA and insights into the FDA approval process broaden and strengthen our capabilities in ways that will benefit our clients.”
Unger may best be remembered for being embroiled (see story) in the review and approval of Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen). At the time, he found himself in contentious dispute with then-CDER director Janet Woodcock that saw her overriding his decision to reject the drug’s approval (see earlier story). In response to a memo from FDA commissioner Robert Califf that ruled in Woodcock’s favor to approve eteplirsen, Unger complained that proper procedures were not followed because Woodcock failed to review all evidence and analyses before she rendered her decision, and that the decision would set a general precedent — where accelerated approval could be provided for a rare disease based solely on the medical and scientific judgment/opinion of the Center director.
Unger was also particularly troubled that the approval could lower the standard for all rare disease drugs. He questioned whether any increase in a surrogate endpoint could be used to support approval for other drugs. “Perhaps granting accelerated approval to drugs that show a mere scintilla of an effect on a surrogate endpoint represents a stroke of brilliance — one that will stimulate investment in the development of drugs for these disorders,” he told Califf. “But in my opinion, this approach should receive broader public (and FDA) input before being implemented. Your decision seems to say that the ‘reasonably likely’ standard for accelerated approval need have no quantitative component at all.”
This trepidation about accelerated approval appears to have again been raised in FDA’s recent controversial approval for Biogen's Alzheimer’s therapy Aduhelm (aducanumab). Accelerated approval has become more of a contentious issue at the agency and was raised during the recent confirmation process for now-commissioner Califf, who vowed to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments (see earlier story). He said that within 30 days of taking office he will “take strong action to hold companies accountable for producing the required scientific evidence after obtaining accelerated approval.”