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 Food and Drug Administration, a story of a blockbuster drug demonstrates the possible pitfalls of removing thorough vetting of experimental treatments. Meanwhile, the CEOs who met with the president reveal what happened behind closed doors, a California lawmaker takes aim at drug coupons, spiking insulin prices make diabetes one of the country's most expensive diseases and more pharmaceutical news.
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)
The Washington Post:
What CEOs Say Happened In Trump’s Closed-Door Meeting With Big Pharma
Since the early days of his campaign, President Trump vocally criticized rising drug prices. Occasionally, he faulted the government's inability to negotiate directly on drugs purchased through Medicare, a practice prohibited by law. But in a meeting Tuesday with pharmaceutical executives, Trump's words were less clear. The executives say, behind closed doors, Trump never brought up government intervention on drug pricing. Meanwhile, Trump's public remarks were loaded with conflicting signals. (Johnson, 2/3)
California Healthline:
Hoping To Control Health Costs, California Lawmaker Targets Prescription Drug Coupons
A California lawmaker has introduced a bill that would ban drugmakers from issuing coupons that lower patients’ prescription copayments for certain drugs. The bill by Assembly member Jim Wood, D-Healdsburg, would prohibit distribution of discount coupons for prescription drugs where a cheaper, FDA-approved equivalent exists. (Bartolone, 2/6)
Sacramento Bee:
Diabetes Among The Most Expensive American Diseases, As Drug Prices Spike
With an estimated 30 million Americans struggling with diabetes, the disease is one of the nation’s most entrenched chronic conditions. It’s also one of the most expensive. (Buck, 2/5)
Stat:
Lilly Cuts 200 R&D Jobs, But Says An Alzheimer's Failure Not Why
On the heels of a recent failure of an Alzheimer’s drug clinical trial, Eli Lilly is eliminating about 200 research and development jobs, a company spokeswoman confirmed, although she maintained the cuts are strictly an effort to fine-tune its workforce and are not related to the recent flop. The drug maker is calling its cutback a “voluntary reallocation program,” a move that will reduce its global R&D staff of roughly 7,000 people by nearly 3 percent. Lilly currently employs about 40,000 people worldwide. (Silverman, 2/3)
NPR:
Heat, Humidity And Aging Make Medicine Less Potent
Most of us have reached for a painkiller, at one time or another, only to discover the date on the label shows it's expired. But what does an "expiration" date on medicine really mean? Is it dangerous if you take it anyway? Less effective? It turns out that date stamped on the label actually means a lot. It's based on scientific evidence gathered by the manufacturer showing how long the drug's potency lasts. (Neighmond, 2/6)
