Articles Posted in FDA

Invokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give…

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes…

Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women. As with all other drugs, Fosamax had side effects, one of which was…

Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five…

Dr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription…

If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right? 21st Century Cures Act: The…

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad…

Boston Scientific is facing more than 36,000 product liability cases because of injuries the mesh has caused, including infections and erosion of surrounding tissue, according to the Minneapolis Star Tribune. Transvaginal slings are used as treatment for incontinence and surgical meshes are surgically implanted to strengthen tissue in women suffering from pelvic organ prolapse. more…

In every lawsuit the court issues key rulings which will impact the outcome of the case. By “court” I mean the presiding judge. Some court decisions end the lawsuit (e.g., a judge granting a defendant’s summary judgment motion). Some decisions kick a leg of the stool out from under one party (granting a motion to…