Perspectives: FDA Nominee’s Laissez-Faire Regulatory Posture Bad For Public Health
Read recent commentaries about drug-cost issues.
Stat:
Scott Gottlieb's Fervor For Deregulation Could Harm Patients
The Senate will soon begin the process of considering President Trump’s nomination of Dr. Scott Gottlieb, who has close professional and financial ties with the pharmaceutical and biotechnology industries, for commissioner of the Food and Drug Administration. A trial that began in a federal courtroom in Boston in January is a timely reminder of how the laissez-faire regulatory posture that Gottlieb is expected to promote can harm the public’s health. (Renee M. Landers, 3/16)
The Hill:
Trump’s Nominee To Lead FDA Could Make Drug Prices Low Again
President Trump is neither a fan of regulation nor high drug prices. So it is no surprise that his nominee to head the Food and Drug Administration, Scott Gottlieb, is a candidate sent straight from central casting. Gottlieb, who is himself a doctor, American Enterprise Institute scholar, and former deputy commissioner of the FDA under President George W. Bush, has long been on record as a critic of the FDA’s overly risk-averse approach to approving new drugs and generic forms of existing ones. (Mytheos Holt, 3/17)
Stat:
My Child Is Fighting A Rare Disease. A 'Streamlined' FDA Won’t Help Her
My 4-year-old daughter, Elle, is in the fight of her life. Her older sister, Milla, lost her fight last November. Their opponent? Batten disease, a rare, fast-moving, and fatal condition that destroys the central nervous system’s ability to function. Elle has a chance to help manage, or maybe even beat, her disease that Milla didn’t have: a clinical trial in which an investigational protein is infused directly into Elle’s brain every 14 days. (Frazer Gieselmann, 3/17)
Stat:
Here's One Drug Safety Rule The FDA Should Enact — Quickly
Next month, the Food and Drug Administration is likely to miss another target date for implementing a rule to improve generic drug safety. If that happens, the American public will lose. The rule is important because it addresses a maddening quirk in the law. Right now, brand-name drug makers can change product labels after learning about potentially harmful side effects. But generic companies cannot do the same thing — unless such a change has already been made to the corresponding brand-name drug. (Ed Silverman, 3/20)
Bloomberg:
There's A Middle Ground In Amgen's Drug-Price Battle
The February news that Amgen Inc.'s cholesterol-lowering drug Repatha helped prevent heart attacks was one of the most exciting biotech events of the year, renewing faith in the drug's blockbuster potential. But the full trial results behind that headline, which Amgen released on Friday, disappointed investors, sinking the company's shares more than 6 percent. (Max Nisen, 3/20)
Bloomberg:
PTC Sticks Its Face In A Drug-Pricing Wasps' Nest
It's generally considered good sense to give wasps' nests a wide berth. But PTC Therapeutics Inc. just paid $140 million in cash and stock for the pleasure of sticking its face in one. PTC on Thursday bought the Duchenne Muscular Dystrophy (DMD) drug Emflaza from Marathon Pharmaceuticals. The drug is an old steroid widely and cheaply available in other countries. Marathon got FDA approval for it last month and proceeded to price it at a hefty $89,000 per year. (Max Nisen, 3/16)
The Philadelphia Inquirer:
A Toehold On The Confusing World Of Pharma Pricing
I'm about to violate my own HIPAA protections to illustrate the illogical nature of health-care costs. I have toenail fungus on one toe. Right foot, middle toe. Gross, I know. I never did anything about it until a routine visit to the dermatologist last year. When she saw that nasty dawg, she told me there were meds that could fix it. (Michael Smerconish, 3/19)
Bloomberg:
Eli Lilly Wants You To Know Its Price Hikes Don't Work
The drug-pricing debate focuses too much on President Donald Trump's Twitter account, and too little on the fact that price hikes don't work that well any more. According to a report it released Monday, Eli Lilly & Co. had a 50-percent-off sale on its drugs in the U.S. in 2016, giving half the list price of its medicines back to insurers and pharmacy benefit managers, on average. It raised list prices by 14 percent, but only received 2.4 percent of that increase. (Max Nisen, 3/20)
