Look at a cautionary tale New drug two possible stories: First and only for preterm birth Or the price spike? $10 to $20 per injection to $1500 per injection Estimate impact on HC system: $30,000 per pregnancy for as many as 140,000 pregnancies per year or $4.2 billion
Someone started a FB page where patients expressed anger, can ’t tell who started page and their agenda The mainstream media reported that the page existed and had quickly gained fans
What happened: March of Dimes, who had been worried about purity and consistency of the compounded drug and also had received $1M in donations from KV, praised Makena March of Dimes claimed they were not informed about cost ahead of time and as media backlash continued, they removed support from KV
What happened: First, members of Congress announced they ’d look at orphan drug determinations The FDA announced they would not enforce exclusivity with legitimate scripts KV shares plummeted more than 30% KV announced a price cut
If a video mentions a drug, then safety information needs to be embedded within the video Four applicable FDA Warning Letters: not about YouTube or video, but the content not following existing guidelines