FDA Issued Stop Distribution Letters to Companies Producing BMPEA-containing Supplements

4/29/2015 Pressure from various officials finally got the FDA to step in regarding beta-methylphenethylamine (BMPEA), a substance used in weight loss, energy boosting and pre-workout supplements. The FDA issued stop distribution letters to companies producing BMPEA-containing supplements. This is a move I can support, unlike many other FDA positions on non-Big Pharma products. Image: Wikipedia,

States Asking Big Pharma About Astronomical Drug Prices

Colorful Pills by Vera Kratochvil Continual increases have states asking big pharma about astronomical drug prices. Many states are even proposing legislation that will force big pharma to share its development costs and profits as justification for ever-increasing prices. Tony DeLuca, a democratic representative in Pennsylvania, introduced legislation this week saying, “We need to have some

Medtronic’s Preemption Win in the 10th Circuit – With An Interesting Twist

The Tenth Circuit issued an opinion on Tuesday, finding that state law claims asserted against Medtronic, manufacturer of the InFuse bone growth stimulator were preempted by FDA approval of the medical device under the Medical Device Act (“MDA”). Plaintiff in the case alleged that Medtronic representatives promoted an off-label, posterior surgical approach for the device,

Food Safety Experts have done What with Big Tobacco?

In a landmark investigation released this week, the Center for Public Integrity (CPI) uncovered the alarmingly small and insular circle of experts who are used by food manufacturers to determine if a new ingredient is “Generally Regarded As Safe,” or GRAS. The investigation discovered that at least one of 10 particular consultants participated in over

Is the GRAS Food Safety process a Racket?

A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts.