For Lessons On Dangers Of Relaxing FDA Regulations, Look No Further Than This $94K Cancer Drug
In an era where officials speak of deregulating and "streamlining" the FDA, a story of a blockbuster drug demonstrates the possible pitfalls of removing thorough vetting of experimental treatments.
Los Angeles Times:
Trump And Congress May Make It Easier To Get Drugs Approved — Even If They Don’T Work
In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer. A study had found that only a small number of patients — those with a certain gene mutation — might be helped by the drug, the company said.The news upended a 2010 decision by the Food and Drug Administration to greatly expand use of the $94,000-a-year drug, despite warnings from a panel of experts that said there was little evidence it actually worked. (Petersen, 2/3)
The New York Times:
Trump’s F.D.A. Pick Could Undo Decades Of Drug Safeguards
President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk. (Thomas, 2/5)