Pharmaceutical

FDA chief nominee Califf faces tough opposition from senators

fda logo FDA chief nominee Califf faces tough opposition from senatorsDr. Robert Califf’s long-term, significant ties to the pharmaceutical industry prove he would be soft on drug companies pushing new opioid painkillers which, in turn, would worsen the country’s prescription drug abuse epidemic, and for this reason, Califf is unacceptable choice to head the Food and Drug Administration (FDA), said Sen. Joe Manchin, D-W.Va. in a written statement. Manchin added he would filibuster the nomination, using that time to read letters from West Virginia families affected by opioid abuse.

Califf currently serves as the FDA’s deputy commissioner for medical products and tobacco. His 2014 financial disclosures revealed he had been funded by several major drug makers including Amgen Inc., Bayer Healthcare LLC, Bristol-Myers Squibb, Eli Lilly and Co., Janssen Research & Development LLC, Merck & Co Inc., Novartis AG, and Roche AG.

Califf had previously worked as a cardiologist and medical researcher at Duke University, where he oversaw clinical trials of several pharmaceutical drugs prior to their being reviewed by the FDA. In one controversial case, during a study on the blood thinners it was revealed that two blood-testing devices, called INRatio, had been the subject of two FDA warning letters over concerns that the devices could deliver false test results. The devices were recalled, but researchers continued to use them during testing of certain blood thinners. This data was ultimately used by the FDA and drug regulators in other countries to show safety and effectiveness in order to approve the drug. This issue prompted an investigation by European drug authorities; however, the FDA has yet to review the case.

Democratic presidential candidate Sen. Bernie Sanders has also expressed concerns about Califf’s nomination for similar reasons. Currently, Califf’s nomination is on hold until lawmakers make a final decision.

Sources:
Law360