A proposal to encourage drugmakers to develop new antibiotics by offering market exclusivity vouchers could cost an additional $4.5 billion in public and private drug spending, according to a study published Oct. 20 in Oxford Academic.
A bill proposed in 2018 called the REVAMP Act introduced the idea of offering drugmakers market exclusivity vouchers if they developed new antibiotics, which could be later redeemed when seeking approval for another drug.
The bill never gained traction, but researchers looked into the costs of the proposal because they thought the idea would come back up amid a growing interest in the scarcity of antibiotics and increasing efforts to lower drug costs.
Researchers found that the bill would have cost an additional $4.5 billion in drug spending over the course of a decade if the REVAMP Act had taken effect in 2007. The excess cost was attributed to the added exclusivity drugmakers would have received for drugs that would have otherwise faced generic competition, according to STAT.
The study was conducted by identifying 10 antibiotics approved from 2007 to 2016 that would likely have qualified for a market exclusivity voucher under the REVAMP Act. By using a simulation, researchers matched the antibiotics with top-selling drugs that had been fast-tracked for approval but faced market exclusivity within a year, following the conditions required by the bill.
Looking at all other drugs, not just the fast-tracked ones, increased the 10-year cost estimate to $26.9 billion.
Many large drugmakers, including Novartis, AstraZeneca and Sanofi, have avoided antibiotic development, according to STAT. Yet, at least 2 million people in the U.S. get an infection resistant to current antibiotics each year, and at least 23,000 die. There hasn't been a new class of antibiotics since the 1980s.
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