Every now and then our government gets something right. This is one of those times.
What is unfortunate is that it should have never come to this in the first place. Because 20 years ago our government got it really wrong, for which we are now paying a steep price.
Misguided regulation requiring too many patients for clinical trials implemented by the FDA the 1990s drove virtually all of the pharmaceutical companies out of the antibiotic research area, leaving us vulnerable to the certain development of bacterial resistance, and the illness and death that accompany it. Resistant infections now kill more Americans per year than breast and prostate cancers combined.
Yet, now there is a serious effort to correct this with backing from Congress and the FDA. It effectively reverses 1990s policy by allowing trials consisting of very small numbers of patients (approximately 200) in cases where there are unmet medical needs.
Antibiotics expert and ACSH advisor Dr. David Shlaes, who has long worked with the FDA on this critical issue explains:
The FDA is already moving in the direction envisioned by the proposed LPAD (Limited Population Antibacterial Drug) legislation. This is clearly seen in the recently released draft guidance in developing antibacterial drugs for patients with unmet needs - i.e. serious antibiotic resistant infection. Most important, is that the FDA is finally backtracking from the days where it was almost impossible to develop new antibiotics to trying and succeeding in finding new ways to bring needed drugs to patients and physicians. That said - they still have a long and uphill road to climb. Maybe the proposed LPAD legislation would make this easier for them - I don t know.
ACSH s Dr. Josh Bloom notes, It s unfortunate it had to come to this. Had things been done properly, there would have been 20 years of work followed (presumably) by a decent, steady flow of badly-needed new drugs. Not only did that not happen, but by now running small trials in sick patients, safety issues will inevitably pop up. Still, this is far better than two years ago.
And it is nice to know that, like almost nothing else these days, the legislation is bipartisan. Here is the letter sent by ISDA to Senators Hatch (R, Utah) and Michael Bennet (D, Colorado). And a bill supported by both parties in the House was introduced this past Friday. There is no doubt it will pass.
They are probably just as scared as the rest of us if not, they should be.