Here we go again. Last month, this column discussed the poor decision making that went into the pricing of Makena, the injection to prevent preterm labor in certain at-risk patients marketed by K-V Pharmaceutical Co., of St. Louis. (See BioWorld Today, May 3, 2011.) I could have added something about the gout drug Colcrys, approved in October 2009 and manufactured by URL Pharma Inc., of Philadelphia, which has caught similar flak . . . but I didn't, because the cases are actually quite different.
Back in June 2006, the FDA launched a formal initiative to get unapproved drugs off the market. That seems like a laudable goal. Over the years there have been some notable cases of unapproved products that resulted in injury or death. A high potency vitamin E injection called E-Ferol used to prevent blindness in premature infants, for instance, resulted in an estimated 40 deaths before it was yanked in 1983. Unapproved formulations of quinine used off-label for leg cramps resulted in 93 deaths before being banned in 2006. But while keeping dangerous medicines from the public is the core of the FDA's mission, some of the negative consequences of that effort have been on display over the last month . . . and served to further tarnish the industry in the eyes of the public.
It has become common wisdom that, in the face of patent expirations and sparse pipelines at major pharma companies, biotechs are in a strong position to negotiate advantageous deal terms – and not just companies with late-stage assets, but a whole spectrum of the industry. Sounds like good times ahead. But as 2011 gets under way, it's not so clear that the industry has the upper hand in its dealings with big pharma, nor that these large companies are necessarily looking first to the biotech industry to solve their problems.
The year is dead, long live the year. It's hard for us to resist looking back from time to time, nor should we. We live moment by moment, so it can be surprising to widen our view and see how much has changed in a year.