News Scan for Feb 24, 2016

FDA candidate confirmed
H5N1 outbreaks in France
MDR-TB drug partnership

US Senate approves Califf to head FDA

The US Senate today overwhelmingly confirmed Robert Califf, MD, as the new Food and Drug Administration (FDA) commissioner after nominal opposition faltered, media outlets reported.

Califf was approved by an 89-4 majority after opposition speeches by Sens. Edward J. Markey, D-Mass., Joe Manchin III, D-W.Va., Kelly Ayotte, R-N.H., and Richard Blumenthal, D-Conn. They focused more on what they perceived as a failure of the FDA to address addiction to prescription painkillers than on the nominee himself, the New York Times reported.

Califf, a cardiologist and clinical researcher from Duke University, was also opposed by presidential candidate Sen. Bernie Sanders, D-Vt., because of past support of his research by the drug industry, the Washington Post reported. But Califf, in a confirmation hearing last fall, defended the funding, which he said is routine practice.

"I think if you look at my record, I've never been a proponent of lowering standards. If anything, I've argued for raising them," he said at the hearing. He added, "To advance, we must find common ground with industry and academia on the science without compromising [the] fundamental role of the FDA."

Califf received broad support from health and patient advocacy groups, the Post reported.

In a statement of support, Health and Human Services Secretary Sylvia Burwell said, "Dr. Califf is the right person with the right experience to build on the FDA's unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market. I look forward to working with Dr. Califf to ensure the FDA can carry out every aspect of its critical mission."

Califf succeeds Margaret A. Hamburg, MD, MPH, who left the FDA in March 2015 after heading the agency for 6 years.
Feb 24 New York Times story
Feb 24 Washington Post article
Feb 24 Burwell statement


France reports two new H5N1 avian flu outbreaks

France's Dordogne region is responding to two outbreaks of highly pathogenic H5N1 avian flu, according to a report yesterday from French agricultural officials to the World Organization for Animal Health (OIE).

The first outbreak occurred on a farm in the Dordogne commune of Saint-Paul la Roche. Officials identified H5N1 during the course of surveillance related to a Nov 2015 outbreak on the farm, and the 2,000 susceptible ducks are scheduled to be destroyed today.

The second H5N1 outbreak occurred on a farm in the commune of Beauregard et Bassac. The virus was confirmed in ducks ready to begin the gavage process (oral feeding for foie gras production), and the 6,000 susceptible ducks will be culled tomorrow.

The OIE report says that the causes of the two outbreaks are unknown.
Feb 23 OIE report


Tuberculosis drug partnership allows access to life-saving treatments

The World Health Organization (WHO) today announced an initiative that will allow countries to access delamanid, a drug that treats multidrug-resistant (MDR) tuberculosis (TB), through the Global Drug Facility (GDF).

The initiative represents a collaboration between the Stop TB Partnership, which administers the GDF, and Otsuka, the manufacturer of delamanid, according to a Stop TB Partnership news release. The GDF provides low-cost access to drugs that effectively treat MDR-TB and extensively drug-resistant TB.

Delamanid joins bedaquiline, the other MDR-TB treatment available through the GDF. Availability and accessibility of two effective drugs is predicted to significantly improve MDR-TB treatment outcomes and reduce deaths, according to the release.

The partnership attempts to remove barriers to MDR-TB treatment, including the fact that drugs prescribed to treat resistant strains are expensive and must be used for periods that can last more than 2 years. Only 50% of the approximately 500,000 people diagnosed as having MDR-TB each year are treated successfully, the WHO said.

Delamanid is available now through the GDF for $1,700 per 6-month, full-course treatment. All countries eligible for drug financing through the Global Fund to Fight AIDS, TB and Malaria can access delamanid through the GDF.

The partnership represents movement toward the WHO's target to end TB as a global health threat by 2035.
Feb 24 Stop TB Partnership press release

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