No vote in US Congress on proposal to create new pathway for approving antibioticsBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1767 (Published 31 March 2015) Cite this as: BMJ 2015;350:h1767
- Peter Doshi
US senators agreed late on 26 March to “set aside” a proposal to create a special approval pathway at the Food and Drug Administration (FDA) for antibiotics. Public interest advocacy and government watchdog organizations celebrated the news after scrambling to urge senators to vote against the amendment, which had been added to the US congressional budget bill and introduced earlier in the day.
“The amendment sounded innocuous, but it sets the stage for a very risky bill,” said Diana Zuckerman, president of the National Center for Health Research. Zuckerman, who coauthored a commentary published in The BMJ last week,1 warned that current congressional efforts would “roll back” historical regulatory standards meant to protect patients. In the hours leading up to the Senate session, her team urged dozens of senators to vote against the amendment.
The amendment aimed “to establish a deficit-neutral reserve fund relating to ensuring that patients, …