Posts Tagged ‘FDA’

A Revealing FDA Op-Ed About Lorcaserin and Obesity

September 10, 2020 — Back in February we complained about “a near complete failure of transparency in drug safety decision making” by FDA. Our complaint had to do with taking lorcaserin (Belviq) off the market. Today, FDA took a step toward a bit more transparency. In the New England Journal of Medicine, senior FDA officials explained their thinking about […]

The Tortured Pathway for a New NASH Treatment

June 30, 2020 — It’s tough getting good information these days. Good, factual information. Everybody wants to spin it. That’s undeniable in public policy. But it also seems to be true in drug development. Yesterday, the FDA definitively rejected an application from Intercept Pharmaceuticals for a new drug to treat NASH – nonalcoholic steatohepatitis. The company was shocked. Its […]

Quiet Progress: FDA OKs Setmelanotide Priority Review

May 18, 2020 — We call it stealth progress. Rhythm Pharmaceuticals last week gained approval from FDA for a priority review of setmelanotide for rare genetic forms of obesity in children. The indications are for obesity treatment in POMC and LEPR deficiency. Furthermore, the FDA has indicated it doesn’t plan to hold a public hearing on this drug This […]

Pseudoscience in the Midst of a Pandemic

March 18, 2020 — A public health emergency can have an unfortunate side effect. With the coronavirus pandemic, pseudoscience, quackery, and fraud are emerging, too. Diets and supplements to “boost” your immune system are a common form of this fraud. Honestly, sometimes this sort of misinformation flies under the radar of normally discerning people. But we praise Dietitians of […]

FDA Requests Lorcaserin Withdrawal, Scant Disclosure

February 14, 2020 — FDA yesterday requested that Eisai withdraw lorcaserin (Belviq®) from the market due to a small increase in cancer observed in a large cardiovascular safety study. Eisai disagreed with the request but complied with the request nonetheless. We have no data to help us understand what is going on. Is FDA over-reacting to a spurious observation? […]

Promise for a New Targeted Obesity Therapy Soon

August 9, 2019 — New data from Rhythm Pharmaceuticals this week tells us that a new, highly targeted obesity therapy may become available soon. The data come from two phase 3 studies of setmelanotide in rare cases genetic obesity. With these positive results in hand, Rhythm expects to file for FDA approval in late 2019 or early 2020. Thus, […]

Getting Tangled Up in Added Sugar

July 7, 2019 — How much added sugar is in a five-pound bag of sugar? It’s taken a while, but FDA has come up with a final answer to this challenging question. None. It’s all sugar, nothing added. The same goes for honey, molasses, or maple syrup. It turns out that the definition of “added” can be quite tricky. […]

When Adding Sugar Doesn’t Add Up to Added Sugar

April 20, 2019 — We are in the midst of a great change in how our food is labeled for nutrition. The Nutrition Facts label goes back to 1993, with no changes since 1999. That’s when trans fats gained a place on the label. Now, starting in 2020, the label will call out added sugar. That should be simple, […]

Plenity: A Capsule for Obesity That’s Really a Device

April 16, 2019 — FDA has just cleared a new capsule for obesity care that doesn’t fit neatly into any of the sorting boxes for obesity treatment. It’s not a drug, even though it looks like one. Instead, it’s a device. It’s a capsule full of hydrogel particles that swell into a mass to help your stomach feel full […]

What’s Healthy? FDA Will Have to Get Back to Us on That

April 3, 2019 — Just about three years ago, FDA started working on a new definition to guide your healthy eating. Don’t worry, they’re on it. Yep, they’re definitely going to issue new rules for what it takes to make a claim that a food product is good for you. But you have to understand. This takes time. We’ve […]