FDA Policy/General

Hacked Clinton Email Implicates FDA in Irregularities

A Hillary Clinton presidential campaign hacked email released by Wikileaks shows how former president Bill Clinton and other top Democrats lobbied Biogen and FDA to gain a compassionate use exemption for Tysabri (natalizumab) and its use in a dying top donor, Fred Barron. At the time (2008), the drug was approved for treating multiple sclerosis and being studied in myeloma patients. According to the email, Barron did not meet entry criteria to qualify for taking the drug.

Their efforts persuaded then-commissioner Andrew von Eschenbach to direct agency officials to discuss the matter with Biogen. “FDA told them there would be no prejudice to the clinical trial if this drug were used for Fred,” the email said. “They were appreciative but gave no indication they would change their position, which is that a corporate decision has been made they would not go outside the clinical trial. I am really upset about this, personally, since FDA has been great to help.”

Eventually, with help from Nancy Pelosi (D-CA), FDA and the Mayo Clinic worked together to get the drug administered without the company’s consent, according to the Dallas Morning News but it was unsuccessful in saving Baron’s life.

Meanwhile, another hacked email showed how the Clinton Campaign monitored the nomination process of Robert Califf, particularly allegations that he was too close to industry to take on the leadership position. The email contended that when Bill Clinton was in office, his commissioner, David Kessler, was “clean” from an industry influence perspective. “We could certainly signal that we want someone willing to stand up to Pharma (in the same way Kessler stood up to Tobacco),” the email suggested.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome