Rep. DeLauro investigates recent device approvals
This article was originally published in The Gray Sheet
Executive Summary
Rep. Rosa DeLauro, D-Conn., requests information from FDA on all devices, drugs and biologic products approved or cleared during the final days of the Bush administration - between November 2008 and January 2009. "I long have been concerned about the influence of industry and political interests in the approval process," DeLauro wrote in a Feb. 12 letter to acting FDA Commissioner Frank Torti. "I fear that this influence has permeated the culture of the agency and has resulted in the approval of a number of products that later were proven to be unsafe and/or ineffective." DeLauro asks for a response by Feb. 26
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.