No vote in US Congress on proposal to create new pathway for approving antibiotics.

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, 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, including military members and veterans, have access to new antibacterial drugs that treat serious or life-threatening infections through the creation by the Food and Drug Administration of a limited population approval pathway for antibacterial drugs.” Vijay Das, of the non-profit consumer advocacy group Public Citizen, called the amendment a “reactionary assault on safety and science that would undermine the FDA, drive up healthcare costs, and harm patients and public health.” He added, “This amendment does nothing to address the scientific bottlenecks to antibiotic drug discovery.” Critics associated the amendment with other active congressional efforts. Das said it was linked to the 21st Century Cures Act, which he described as an “extreme deregulatory bill.” Zuckerman described the amendment as a “vague version of the PATH [Promise for Antibiotics and Therapeutics for Health] Act,” which was introduced into the Senate in January by the Republican Orrin Hatch and the DemocratMichael Bennet, who also co-sponsored the budget bill amendment. Like the amendment, the PATH Act called for the creation of a “limited population pathway” for approving antibiotics and was the focus of an investigation published last week in The BMJ. If passed, the PATH Act would lower the evidentiary requirements for FDA approval of new antibiotics that target “unmet medical need” in specific, limited populations of patients. But, as The BMJ’s investigation showed, despite support from groups such as the Infectious Diseases Society of America and the Pew Charitable Trusts, it is unclear whether drugs approved under PATH would actually be limited in their use and not prescribed “off label,” a particular concern because of the potential for increasing antimicrobial resistance. The proposed legislation explicitly states that it is not intended to “restrict the prescribing of antibiotics” by healthcare professionals. The BMJ’s investigation found that there was no evidence that five new antibiotics approved under legislation similarly meant to simulate the development of new antibiotics and passed in 2012 met previously unmet medical need, tackled antimicrobial resistance, or were more effective than pre-existing antibiotics. Zuckerman said, “Our major concern is that the bill would allow antibiotics to be approved based on very small ‘targeted’ studies. Most studies would not include any children or enough women, people over 65, or minorities to establish safety or effectiveness for them. “After approval, however, the new antibiotics would be widely advertised and used by all adults and children, potentially harming them.” The amendment came on the eve of the release of a national action plan against antibiotic resistance, published by theWhite House. National Center for Health Research staff said, “The plan makes it clear that the approach of this amendment to the Budget bill will not even make a dent in the problem of antibiotic resistance. And, without the safeguards that are needed, it will make matters worse.” Critics of the PATH Act and the 21st Century Cures Act have endorsed a competing bill known as the Helping Effective Antibiotics Last (HEAL) Act, introduced by the Democrat congresswoman Rosa DeLauro. Lisa Plymate, co-chair of the National Physicians Alliance FDA Taskforce, said that HEAL “goes further than current proposals to address antibiotic resistance” and “ensures new treatments are not merely new, but are also effective and safe—the heart of what matters to patients and physicians alike.” The offices of Senators Hatch and Bennet did not respond to a request for comment.