In February 2014, the Food and Drug Administration (FDA) along with Michele Obama announced an overhaul to the nutrition facts label required on all packaged foods. Among the proposed changes includes updating the serving sizes.
"Big government" is a toxic term. It has become shorthand for waste, debt, big brother, and corruption rolled into a neat, yet nefarious, package. But when it comes to the function of government, bigger can be better. And bigger can strengthen capitalism.
Assuming that the judge affirms his position in his final ruling and the FDA decides not to appeal (or appeals and loses), this decision represents a major victory for Amarin and the pharmaceutical industry more broadly.
Misleading pharmaceutical marketing can be far more insidious than Kim Kardashian's recent social media flub with Diclegis, and it is with these more serious transgressions that the FDA must keep a careful eye.
Foods we once enjoyed without thinking suddenly aren't so delicious now that chain restaurants and movie theaters are complying with FDA mandates to post menu item calorie, fat, sodium and sugar content (I'm talking to you, Cheesecake Factory, Starbucks and Pizza Hut).
After stopping thalidomide, Dr. Kelsey could've walked through the revolving door into a career with Big Pharma, but she stayed at the FDA, retiring in 2005 at 90 years old. Now that's a life of public service.
Although designated an "orphan disease" because it affects less than 200,000 Americans, Amyotrophic Lateral Sclerosis (ALS) saw millions of benefactors stand tall last year to douse themselves with ice water in support of a cure. The numbers were staggering.
What the 21st Century Cures Act ignores is the prevailing, patient agnostic approach to drug development. We need to move toward a patient-centric approach to drug development and approval, and we should start with cancer treatments.
Over a month ago, I had the chance to attend hearings at the FDA on a drug being considered for approval for female sexual health. Even as the weeks pass, the experience remains fresh in my mind and catalyzes lots of conversations (with folks who like to discuss this sort of thing).
The cap on dietary fat has, indeed, long outlived any utility it ever had. So, too, has a big, fat debate that has diverted us for far too long to nutrients, from the foods that would be a far more constructive, and healthy focus.
Ending deferral of blood donations based on sexual orientation entirely is the only way to simultaneously avoid discrimination, preserve the safety of the blood supply, and maintain the FDA's credibility.
Federal regulators are human, and, like everyone else, they make mistakes. The public reasonably expects that, upon discovering a significant mistake, regulators will take appropriate action to correct it.