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November 18, 2015.
The Senate hearing to weigh the appointment of Robert Califf to be the next commissioner of FDA was a fairly friendly event, with members of the Senate Health, Education, Labor and Pensions (HELP) Committee tossing out mostly softball questions about a range of policies and programs. The nominee agreed that FDA should move forward with efforts to develop medical countermeasures, combination products, sunscreens, and therapies for neonates, and that there’s a need to improve postmarket surveillance of medical devices and to clarify labeling for seafood.
In response to several comments about rising drug prices, Califf agreed with some committee members that FDA’s best strategy for addressing drug costs is to do “a good job with generics.” This involves moving generics through the approval process more efficiently, he said, and to support biosimilars coming along.
Efforts to streamline clinical trials also could reduce development costs, Califf suggested, and keeping track of looming drug shortages can help avoid monopoly situations in the market. And he acknowledged that standards on drug compounding could support use of these products as alternatives to costly medicines while generics are in development.
The most pointed comments came from Sen. Bernie Sanders (D-Vt), who stated that he did not support Califf’s nomination because he’s “not strong enough on drug cost issues.” Sanders insisted that Americans should be able to reimport brand-name drugs from Canada, and that Medicare should be able to negotiate drug prices. Califf noted the Obama administration supports Medicare negotiation on some drugs, but expressed concerns about ensuring the safety of reimports.
Several senators raised concerns about whether Califf’s work for pharma companies in conducting clinical trials at Duke University opens him to bias and industry influence. To questions from Sen. Elizabeth Warren (D-Mass) about the extent of sponsor control over trial design, analysis and publications, Califf outlined how developing a clinical protocol is a collaborative effort between sponsor and investigators, with vetting from FDA and institutional review boards. But he emphasized that all his projects ensured researcher access to study databases and control over resulting publications.
Califf concluded by pointing out that he donated research payments from industry to nonprofit organizations to show that “I’m interested in the work, not the money.” He emphasized the importance of academia collaborating with industry, while retaining their independence in developing innovative technologies as safe and effective therapies for patients.