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MARKET INTEL by PharmaCompass
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By PharmaCompass
2018-09-20
Impressions: 64 Article
The FDA has pulled out all stops to reduce antibiotic resistance (AMR). Last week, FDA Commissioner Scott Gottlieb announced the agency’s 2019 Strategic Approach for Combating AMR. “This is an ongoing, agency-wide initiative to build on our past efforts, and to coordinate policy and external partnerships to help confront AMR,” Gottlieb said in a speech at Pew Charitable Trusts last week.
Antimicrobial resistance — the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug — is a serious, complex and costly public health problem.
According to the CDC, every year at least 2 million people in the United States alone develop serious infections caused by antimicrobial-resistant pathogens, and at least 23,000 people die as a direct result of these infections.
Gottlieb said FDA’s strategy to deal with AMR is comprehensive, and brings all its centers to work together, via one platform. The strategy addresses four key areas.
First, FDA is facilitating product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms.
Second, the agency is promoting antimicrobial stewardship. “Careful stewardship across human and animal health can help preserve the effectiveness of available treatments and may help slow the development of antimicrobial resistance,” Gottlieb said.
Third, the FDA is supporting the development of tools for surveillance of antimicrobial use and for determining when pathogens develop resistance.
And finally, the agency is advancing scientific initiatives to help all stakeholders answer critical questions related to AMR.
FDA’s Center for Drug Evaluation and Research (CDER) Office of Antimicrobial Products also issued a Request for Information (RFI) to solicit informal input from the public and private sectors to obtain external input into developing an annual list of regulatory science initiatives specific for antimicrobial products.
FDA has also brought into effect reimbursement reforms for antimicrobial treatments. These could include “a mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes,” Gottlieb said.
Gottlieb also offered the idea of using a “subscription-based model” that could see hospitals paying a flat rate for access to a certain number of doses of a new antimicrobial.
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