FDA Issues Draft Guidance to Aid Development of Critical Drugs

FDA is discussing with other agencies changing the model for reimbursement of certain new, anti-microbial drugs that meet critical public health needs, possibly by using a licensing model so that acute care institutions that are most likely to prescribe these medicines would pay a fixed licensing fee for access to the drug.

The U.S. Food and Drug Administration has issued a draft guidance to help companies develop drugs using the Limited Population Pathway for Antibacterial and Antifungal Drugs, also known as the LPAD pathway, which was established by Congress under the 21st Century Cures Act. In a statement, FDA Commissioner Dr. Scott Gottlieb said the agency believes this program will advance development and approval of antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs.

When finalized, the guidance will support drug development by describing the criteria, processes, and other general considerations for drugs approved under the LPAD pathway. In reviewing an application submitted under the pathway, FDA will consider the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in the limited population.

"The guidance will also assist companies in developing labeling, including prescribing information, patient labeling and carton/container labeling, to inform the medical community that the drug was approved under the LPAD pathway based on a benefit-risk assessment in a limited population.The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. According to our colleagues at the Centers for Disease Control and Prevention, each year in the U.S. at least 2 million people become infected with bacteria that are resistant to antibiotics and 23,000 people die each year as a direct result of these infections," Gottlieb's statement says. "As more and more bacteria grow resistant to currently available antibiotics, we must tackle the issue on all fronts and seek new approaches to this persistent and potentially deadly problem. This means helping to ensure good antibiotic stewardship and use in appropriate clinical scenarios. It also means spurring the development of new antibiotics, for instance, by pursuing novel incentive models for developers that take into consideration the challenging economic and usage dynamics of these products."

He noted that, as resistant strains of bacteria increase, "there has unfortunately been an overall decline in antibiotic drug research driven largely by the significant obstacles to developing innovations in this category. This is especially true when it comes to developing new antibiotics that work through novel mechanisms that can evade existing patterns of resistance." The cost of developing new drugs also is a factor, and his statement discusses a set of incentives created by Congress for antibacterial and antifungal drugs that treat serious or life-threatening infections. This includes the qualified infectious disease product (QIDP) designation; new drug applications that are designated as QIDP can receive fast track designation, priority review designation, and a possible five-year extension of any exclusivity that the application qualifies for upon approval.

FDA is discussing with other agencies, such as the Centers for Medicare and Medicaid Services, changing the model for reimbursement of certain new, anti-microbial drugs that meet critical public health needs, possibly by using a licensing model so that acute care institutions that are most likely to prescribe these medicines would pay a fixed licensing fee for access to the drug, which would offer them the right to use a certain number of annual doses.

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