Bipartisan House Bill Would Add 12 Months Transferable Exclusivity for 'Priority' Antimicrobials

Regulatory NewsRegulatory News | 02 July 2018 |  By 

A newly introduced bipartisan bill would seek to encourage the development of new antimicrobials by offering sponsors an additional 12 months of transferable exclusivity once certain priority antimicrobials are approved.

According to a summary provided to Focus by House staff, the bill known as the Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 and introduced by Reps. John Shimkus (R-IN) and Tony Cardenas (D-CA), would create a committee of experts from government and the physician community to develop a list of critical need antimicrobial priorities within 60 days. And within 180 days, the committee would publish a list of such antimicrobials.

Sponsors may request designation as a “priority antimicrobial product” before or after filing for licensure. But only 10 exclusivity awards will be issued, according to the bill summary, and Congress will discuss if an expansion of the program is necessary after the ninth is awarded.

Other stipulations: The exclusivity award “must be conveyed to another drug product and can be parceled for periods less than 12 months and to one or more drugs,” the summary says, meaning the additional 12 months does not have to be applied to the antimicrobial and can be sold. 

Biologics, cosmetics and drugs seeking licensure under the supplemental approval pathway are not eligible.

In addition, five years after the enactment of the bill, or after the fifth exclusivity extension is granted, the CDC and GAO will study how the program is working.

Monika Schneider, research associate at the Duke-Margolis Center for Health Policy, told Focus the transferability incentive would make antimicrobial development, which currently does not have a very good return on investment, attractive to both large and small sponsors, particularly as the bill would not require new funding from Congress.

But she also cautioned that a consequence of such a law would be that the development of new antimicrobials would occur at the expense of other patients paying for brand name drugs for a longer period of time.

Kevin Outterson, executive director of the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, explained via Twitter that the exclusivities could be worth more than $1 billion.

The bill comes as the 21st Century Cures Act called to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive criteria, also known as antimicrobial "breakpoints."

The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) also met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

HR 6294


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