FDA and antibiotics

Screen Shot 2014-12-23 at 1.46.58 PMNormally, this wouldn t even make the news. A new antibiotic approved. Not only that, but it belongs to a class of antibiotics (called cephalosporins) from the class of 1960s, which is hardly novel. There are about 60 cephalosporins that have been approved since 1964, when cephalothin was launched by Lilly.
In the twenty years too late is better than nothing department, the antibiotic crisis is squarely in the news today after President Obama issued an executive order that will establish a new inter-agency task force for the sole purpose of developing a national strategy to combat antibiotic-resistant bacteria.
In a hard-hitting op-ed in today s NY Times, food writer Ruth Reichl takes the FDA to task for not taking strong action to limit or ban the use of antibiotics in food animals.
If you are looking for someone who is perfectly suited to interact with, provide guidance to, or simply scream at the FDA regarding their disastrous policies for clinical trials of new antibiotics that have put all of us as risk look no further than Dr. Shlaes first Science 2.0 piece.
We at ACSH have written frequently about the misguided change in mindset by the FDA two decades ago that brought most antibiotic research to a dead stop. No one has been deeper in the FDA trenches than ACSH advisor and infectious disease expert Dr. David Shlaes. He has been blogging, advising, lobbying, begging, and doing just about everything short of pulling his hair out to convince the infectious disease division of the FDA to reverse the disastrous changes in clinical trial policy that caused almost all drug companies to abandon research in this area.
The very good news is that antibiotic research by drug companies is slowly starting up again after a long sabbatical. But almost without exception, the complete story of how we got here is not told.
A long-running controversy has reared its head again whether or not antibiotics should be added to animal feed to promote the growth of cattle, sheep, pigs and poultry. This time, the FDA is considering whether to ban this practice, although they are only talking about voluntary compliance at this time. As would be expected, opinions vary widely, with farmers on one side and various medical and non-governmental organizations, and individuals on the other.
Former vice president of infectious disease research at Wyeth and ACSH advisor Dr. David Shlaes knows a thing or two about dealing with the FDA, and its misguided policies regarding approval of new antibiotics.