The year began with a prediction from Senator Mitt Romney to pharmaceutical executives that “change is coming”. There have been high profile hearings on the topic in the Congress and legislation that moved in both the Senate and the House … Continue reading
In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading
In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading
In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading
I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one … Continue reading
