Yesterday we reported on the alarming rise in the incidence of C. difficile (Clostridium difficile) bacterial infections and deaths due to increases in both its prevalence and its antibiotic resistance. The development and discovery of new antibiotic drugs would help counter the problem, but pharmaceutical companies are largely unmotivated to enter this research arena, mainly because investing in such drugs is not profitable. A new proposal by the Infectious Diseases Society of America (IDSA), however, may change that.
The latest IDSA proposal, announced yesterday, calls on the FDA to regulate certain antibiotics as orphan drugs for rare diseases, which expedites their approval process. First enacted in 1983, the Orphan Drug Act offers companies various incentives, including tax credits and marketing rights, to develop drugs for uncommon diseases (generally those affecting fewer than 200,000 people in the U.S.). A similar program could work for antibiotics, claims IDSA, since the unmet need for this class of drugs is just as great if not greater.
Among the targeted list of drug-resistant infections and superbugs are MRSA and C. difficile, which have reached crisis proportions in the U.S., according to Janet Woodcock, head of the FDA s drug center. Under the IDSA proposal, companies that develop new antibiotics that treat these specific bacterial strains could enroll fewer patients into clinical trials and obtain faster responses from the FDA in order to gain expedited approval. In addition, the IDSA would work with insurers and doctors to ensure that antibiotics approved via this pathway would not be abused, especially by overuse a practice that has contributed to the current situation of drug-resistant germs.
We need antibiotics to be used for life-threatening infections that lack medical treatments ¦and not for your kid s ear infection, Woodcock added.
Yet ACSH's Dr. Josh Bloom was far from convinced that the IDSA proposal would accomplish much. It is unlikely that this would even remotely provide sufficient incentives for drug companies to get back into antibiotic research, he says. Most companies have abandoned their programs in the last decade, and it would require serious financial incentives far above what IDSA proposed to lure some companies back. This is not a problem that will go away anytime soon. At best, this is a modest start."
