Incentives for antibiotics innovation

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Antibiotic-resistant bacteria are an enduring problem on a global scale, as we often have the occasion to report. Addressing the conditions that are conducive to such resistant bacteria is one important tack to combat this problem: For instance, poverty, crowding, and poor sanitation in developing countries favor the spread of germs, and having cheap antibiotics available without a prescription encourages bacterial resistance. Furthermore, in all countries, over-use or taking an inadequate course of these medications also encourages resistance. However, as a recent editorial at points out, the other crucial means of countering such resistant bacteria lies in the development of new antibiotics. Unfortunately, the pipeline for antibiotics is barely existent; the FDA has approved only two new antibiotics since 2008. Enter the Infectious Diseases Society of America (IDSA) which recommends that the development of new antibiotics be supported with research grants and rewarded with tax incentives.

As the doctors who comprise IDSA observe, pharmaceutical companies have little financial incentive to devote resources to the development of antibiotics. Such medications aren't as profitable as drugs used to treat chronic ailments, and the antibiotics that would be necessary to kill current resistant bacteria would still be used only rarely. Thus the FDA is considering a fast track for some new antibiotics, a process that would allow for limited approval based on an initial small clinical trial, instead of the two large ones typically required. Congress has also taken steps to address the dearth of new antibiotics: Included in the FDA user-fee bill (due to be passed in October) is the bipartisan act called Generating Antibiotic Incentive Now (GAIN). GAIN would provide pharmaceutical companies with a greater financial incentive, extending by five years a company's ability to exclusively market a new antibiotic.

The development of antibacterial resistance is pretty much a given, regardless of how carefully an antibiotic is used, says ACSH's Dr. Josh Bloom. There were penicillin-resistant organisms discovered within one year of the introduction of the drug. The only way to stay ahead of the game is by constantly searching for new antibiotics. Unfortunately, this has virtually ceased in the U.S., partly due to more stringent FDA requirements that have made clinical trials much more difficult. We will pay for this sooner or later if it s not addressed.