HELP Advances Califf’s FDA Nomination

Dr. Robert Califf, the White House’s nominee to lead the Food and Drug Administration (FDA), was approved by the Senate Health, Education, Labor and Pensions (HELP) Committee last week by voice vote. Dr. Califf is currently the FDA’s deputy commissioner for medical products and tobacco. He is a cardiologist and a longtime researcher at Duke University. He received statements in support of his nomination from Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) at the start of the executive session. Presidential candidate Bernie Sanders (I-Vt.) was absent from the vote on Tuesday, but expressed his opposition to the nomination in a statement, reiterating concerns he had first voiced during Califf’s confirmation hearing in November. He cites Dr. Califf’s ties to the drug industry and has criticized Califf’s opposition to the importation of drugs from Canada as a means to lower costs. Sen. Sheldon Whitehouse (D-R.I.) also spoke about the need to deal with the price hikes by drug companies producing pharmaceuticals to treat rare diseases. Before his nomination is voted on by the full Senate, Sen. Lisa Murkowsk (R-Alaska) wants the agency to address her concerns regarding genetically-engineered salmon. Chairman Alexander expressed hopes that these conversations would be quick. During the executive session, Chairman Alexander also stated his continued commitment to introducing a medical innovation bill to parallel the House’s 21st Century Cures, but no timeline was offered.

HELP Releases Report on Monitoring of Medical Device Safety

Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee Patty Murray (D-Wash.) has released a report titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” The report includes the results of HELP’s Democratic staff investigation into the bacterial infection outbreak in Seattle stemming from medical devices known as duodenoscopes, used to diagnose and treat conditions of the pancreas and bile duct. The manufacturer of the device, Olympus, knew by early 2013 that bacteria could spread even after cleaning the duodenoscope according to specifications. The outbreak was discovered in September of 2013, but the Food and Drug Administration (FDA) did not begin alerting hospitals and the public until February 2015. A total of 250 people in 10 states and four countries became ill as a result of these particular duodenoscopes. The report concludes that the outbreak was able to spread nationwide because hospitals and federal regulators failed to take timely action. Outdated adverse event databases and untimely and incomplete manufacturer and hospital self-reporting are blamed for the FDA’s misunderstanding of the severity of the outbreaks. The report recommends that Congress fund a medical device monitoring system, and that the FDA implement a way to more quickly communicate information about adverse events.

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