Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.More info
The lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent.
On Jan. 31, 2013, The Pew Charitable Trusts hosted a one-day conference, "A New Pathway for Antibiotic Innovation: Exploring Drug Development for Limited Populations." Pew brought together government regulators, infectious disease physicians, public health specialists, pharmacists, pharmaceutical company representatives, and payors to weigh the merits of a proposed new Food and Drug Administration approval mechanism: a limited population regulatory pathway. The proposal promises to bring urgently needed medicines to the sickest patients by reducing some of the economic and regulatory barriers to antibiotic innovation.
Some general themes emerged from the conference:
- Payors, health care providers, and pharmaceutical companies generally supported the concept of a limited population regulatory pathway.
- The pathway could increase the feasibility and lower the costs of clinical trials for high-need antibiotics.
- Limited population antibiotics would likely command premium pricing, which could provide a reasonable return on investment for antibiotic developers.
- Premium pricing could ensure that limited population antibiotics are not used indiscriminately, thus preserving the effectiveness of these critical drugs over time.
- A special designation or labeling alone would not curtail unnecessary use of the limited population antibiotics, but could signal that these drugs are different from other antibiotics and should be treated accordingly.
- Strict restrictions or penalties on the use of limited population antibiotics were not recommended, but all participants agreed that stewardship—the proper management and data-driven use of these drugs — would be important for success of the pathway.
For more detail, download and read the event proceedings transcript (PDF file).
The President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.More info
Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. According to a Centers for Disease Control and Prevention report, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 of them die. Doctors routinely encounter patients with infections that do not respond to available treatment, and when new drugs come to market, bacteria quickly develop resistance. To ensure that the supply of new antibiotics keeps pace with these evolving pathogens, it is necessary to have a robust pipeline of new drugs and innovative pathways to get this medicine to the patients who need it the mostMore info
The process of creating new medicines is complex, time-consuming, and costly. Moving a potential therapy from concept to market can take between 10 and 15 years and cost developers as much as $1 billion. Indeed, industry also bears the cost of failure: For every drug that ultimately receives approval from the U.S. Food and Drug Administration, some 5,000 to 10,000 compounds don’t make it through the process.More info