Claim: US regulators OK updated version of decades-old antibiotic.
Verdict: SUPPORTS

Retrieved passages:
title: Bad Pharma
text: a competing antibiotic that was known to be effective at a higher dose than was used during the trial. Goldacre writes that 11 children died, divided almost equally between the two groups. The families taking part in the trial were apparently not told that the competing antibiotic at the effective dose was available from Médecins Sans Frontières in the next-door building. Chapter three describes the concept of "regulatory capture," whereby a regulator – such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the United States – ends up

title: Antibiotic use in livestock
text: requiring veterinarian supervision of their use and a prescription. In December 2013, the FDA announced the commencement of these steps to phase out the use of antibiotics for the purposes of promoting livestock growth. Numerous state senators and members of congress showed support for the Preservation of Antibiotics for Medical Treatment Act of 2013 and Preventing Antibiotic Resistance Act of 2015. These acts proposed amendments be made to the Federal Food, Drug and Cosmetic Act which would limit and preserve the use of antibiotics for medically necessary situations. Both of these bills died in Congress in 2015. In 2015, the

title: Veterinary Feed Directive
text: class; these drugs will remain over the counter. The USDA states that Ionophores, Bacitracin, Bambermycins, and Tiamulin will remain over the counter. Injectables, boluses, or other dosages are not affected by this regulation. There are other drugs that can be found through the FDA that will not require a prescription to purchase. To ensure the judicious use of antibiotics in food producing animals, the new regulations went into effect on January 1, 2017 and many drugs changed from OTC to Rx status for medicated water and feed. Distributors and retailers that use these products are required to meet the new

title: Antibiotic
text: is coordinated by the US Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), as well as other US agencies. An NGO campaign group is "Keep Antibiotics Working". In France, an "Antibiotics are not automatic" government campaign started in 2002 and led to a marked reduction of unnecessary antibiotic prescriptions, especially in children. The emergence of antibiotic resistance has prompted restrictions on their use in the UK in 1970 (Swann report 1969), and the EU has banned the use of antibiotics as growth-promotional agents since 2003. Moreover, several organizations (including

title: Antibiotic
text: John Innes Centre and universities in the UK, supported by BBSRC, resulted in the creation of spin-out companies, for example Novacta Biosystems, which has designed the type-b lantibiotic-based compound NVB302 (in phase 1) to treat "Clostridium difficile" infections. Possible improvements include clarification of clinical trial regulations by FDA. Furthermore, appropriate economic incentives could persuade pharmaceutical companies to invest in this endeavor. In the US, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act was introduced with the aim of fast tracking the drug development of antibiotics to combat the growing threat of 'superbugs'. Under this Act, FDA can approve antibiotics

title: Antibiotic
text: 1977. In March 2012, the United States District Court for the Southern District of New York, ruling in an action brought by the Natural Resources Defense Council and others, ordered the FDA to revoke approvals for the use of antibiotics in livestock, which violated FDA regulations. Before the early 20th century, treatments for infections were based primarily on medicinal folklore. Mixtures with antimicrobial properties that were used in treatments of infections were described over 2000 years ago. Many ancient cultures, including the ancient Egyptians and ancient Greeks, used specially selected mold and plant materials and extracts to treat infections. The

title: Antimicrobial resistance
text: standards by which the FDA approves antibiotics targeted at resistant organisms. On 12 December 2013, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 was introduced in the U.S. Congress. The ADAPT Act aims to fast-track the drug development in order to combat the growing public health threat of 'superbugs'. Under this Act, the FDA can approve antibiotics and antifungals needed for life-threatening infections based on data from smaller clinical trials. The Centers for Disease Control and Prevention (CDC) will reinforce the monitoring of the use of antibiotics that treat serious and life-threatening infections and the emerging resistance,

title: Infectious Diseases Society of America
text: resistance and the lack of development of new antibiotics. According to IDSA, new antibiotic development has slowed to a standstill due to market failure and regulatory disincentives. Antibiotics aren't as profitable as other drugs (e.g., drugs to treat chronic conditions such as diabetes or asthma, which patients take for years). Also, the U.S. Food and Drug Administration (FDA) has long delayed publishing workable guidance describing how companies should design antibiotic clinical trials. Moreover, once a new antibiotic makes it to market, physicians hold it in reserve for only the worst cases rather than rushing to use it on all their

title: Triclosan
text: amended tentative final monograph that would establish conditions under which OTC topical health-care antiseptic drug products are generally recognized as safe and effective and not misbranded. FDA is issuing this notice of proposed rulemaking on topical antimicrobial drug products after considering the public comments on that notice and other information in the administrative record for this rulemaking. FDA is also requesting data and information concerning the safety and effectiveness of topical antimicrobials for use as hand sanitizers or dips.” In the 1994 update to the rule, TCS was effectively removed from the drug category which made it available for use

title: Antimicrobial resistance
text: issue up to $62 million from 2013 to 2019. Using authority created by the Pandemic and All Hazards Preparedness Act of 2006, the Biomedical Advanced Research and Development Authority in the U.S. Department of Health and Human Services announced that it will spend between $40 million and $200 million in funding for R&D on new antibiotic drugs under development by GlaxoSmithKline. Antimicrobial susceptibility testing (AST) can help practitioners avoid prescribing unnecessary antibiotics in the style of precision medicine, and help them prescribe effective antibiotics, but with the traditional approach it could take 12 to 48 hours. Rapid testing, possible from

title: ADAPT Act
text: ADAPT Act The Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 was introduced in the U.S. Congress on 12 December 2013. The ADAPT Act aims to fast track the drug development in order to combat the growing public health threat of 'superbugs'. Under this Act, FDA can approve antibiotics and antifungals needed for life-threatening infections based on data from smaller clinical trials. The CDC will reinforce the monitoring of the use of antibiotics that treat serious and life-threatening infections and the emerging resistance, and make the data publicly available. The FDA antibiotics labeling process, 'Susceptibility Test Interpretive Criteria

title: Antimicrobial resistance
text: and make the data publicly available. The FDA antibiotics labeling process, 'Susceptibility Test Interpretive Criteria for Microbial Organisms' or 'breakpoints' is also streamlined to allow the most up-to-date and cutting-edge data available to healthcare professionals under the new Act. On 18 September 2014 Obama signed an executive order to implement the recommendations proposed in a report by the President's Council of Advisors on Science and Technology (PCAST) which outlines strategies to stream-line clinical trials and speed up the R&D of new antibiotics. Among the proposals: The U.S. National Institutes of Health plans to fund a new research network on the

title: Antimicrobial resistance
text: "de-emphasized or dropped development of antibiotics". On January 20, 2016 at the World Economic Forum in Davos, Switzerland, more than "80 pharmaceutical and diagnostic companies" from around the world called for "transformational commercial models" at a global level to spur research and development on antibiotics and on the "enhanced use of diagnostic tests that can rapidly identify the infecting organism". Some global health scholars have argued that a global, legal framework is needed to prevent and control antimicrobial resistance. For instance, binding global policies could be used to create antimicrobial use standards, regulate antibiotic marketing, and strengthen global surveillance systems.

title: Antimicrobial resistance
text: of antibiotic-resistant bacterial strains in livestock. The long-established practice of permitting OTC sales of antibiotics (including penicillin and other drugs) to lay animal owners for administration to their own animals nonetheless continued in all states. In 2000, the FDA announced their intention to revoke approval of fluoroquinolone use in poultry production because of substantial evidence linking it to the emergence of fluoroquinolone-resistant "Campylobacter" infections in humans. Legal challenges from the food animal and pharmaceutical industries delayed the final decision to do so until 2006. Fluroquinolones have been banned from extra-label use in food animals in the USA since 2007. However,

title: Antibiotic use in livestock
text: started cutting down drastically in 1994, now using 60% less. In the Netherlands, the use of antibiotics to treat diseases increased after the ban on its use for growth purposes in 2006. In 2011, the European Parliament voted for a non-binding resolution that called for the end of pre-emptive use of antibiotics in livestock. A revised regulation on veterinary medicinal products, proposed in procedure 2014/0257/COD, would limit the use of antibiotics in prophylaxis and metaphylaxis. An agreement on the regulation between the Council of the European Union and the European Parliament was confirmed on 13 June 2018. In 2011 the

title: Antibiotic use in livestock
text: Korea. In 2007 "The Korea Times" noted that Korea has relatively high usage of antibiotics in livestock production. In 2011, the Korean government banned the use of antibiotics as growth promoters in livestock. In 1970 the FDA started recommending that antibiotic use in livestock be limited but set no actual regulations governing this recommendation. By 2001, the Union of Concerned Scientists estimated that greater than 70% of the antibiotics used in the U.S. are given to food animals (for example, chickens, pigs, and cattle), in the absence of disease. In 2004 the Government Accountability Office (GAO) heavily critiqued the FDA

title: Antibiotic use in livestock
text: among other measures to contain the threat to human health. The CDC asked leaders in agriculture, healthcare, and other disciplines to work together to combat the issue of increasing antibiotic resistance. Some scientists have said that "all therapeutic antimicrobial agents should be available only by prescription for human and veterinary use." The Pew Charitable Trusts have stated that "hundreds of scientific studies conducted over four decades demonstrate that feeding low doses of antibiotics to livestock breeds antibiotic-resistant superbugs that can infect people. The FDA, the U.S. Department of Agriculture and the Centers for Disease Control and Prevention all testified before

title: Criticism of the Food and Drug Administration
text: infants. Since 1993, all EU countries have maintained a ban on rBGH use in dairy cattle. The FDA has also been criticised for permitting the routine use of antibiotics in healthy domestic animals to promote their growth, a practice which allegedly contributes to the evolution of antibiotic-resistant strains of bacteria. The FDA has taken recent steps to limit the use of antibiotics in farm animals. In September 2005, the FDA withdrew approval for the use of the fluoroquinolone antibiotic enrofloxacin (trade name Baytril) in poultry, out of concern that this practice could promote bacterial resistance to important human antibiotics such

title: Antimicrobial stewardship
text: are standards against which therapy may be judged." In the 1980s the antibiotic class of cephalosporins was introduced, further increasing bacterial resistance. During this decade infection control programs began to be established in hospitals, which systematically recorded and investigated hospital-acquired infections. Evidence-based treatment guidelines and regulation of antibiotic use surfaced. Australian researchers published the first medical guideline outcomes research. The term AMS was coined in 1996 by two internists at Emory University School of Medicine, John McGowan and Dale Gerding, a specialist on C. difficile. They suggested "...large-scale, well-controlled trials of antimicrobial use regulation employing sophisticated epidemiologic methods, molecular biological

title: Poultry farming
text: prevention of that bacterial infection.” The FDA is not trying to regulate all antimicrobials at this time - only those antibiotics which are considered “medically important.” For example, bacitracin, a common antibiotic found in over the counter antibiotic ointments, is not classified as “medically important.” Also, ionophores, which are not a part of human medicine but given for improving the health of livestock, are also not included in this regulation. Poultry feed can also include roxarsone or nitarsone, arsenical antimicrobial drugs that also promote growth. Roxarsone was used as a broiler starter by about 70% of the broiler growers between