One of the most pressing scientific issues facing Congress today is the risk that antibiotic resistance presents to human health. Unlike other political-scientific hot potatoes, such as global warming, the House and Senate crossed the aisle to pass a bipartisan bill to speed new antibiotics to market, and are working on a new bill to make FDA approval even easier.
Unfortunately, there is an enormous gap between what the science tells us is needed and the Congressional approach.
In addition to the obvious biological cause of antibiotic resistance, two major problems contribute to antibiotic resistance—lack of new antibiotics to fight resistant bacteria and misuse and overuse of existing antibiotics.
Congress has focused on the first by creating financial incentives for companies to develop new antibiotics, and changing the scientific criteria for FDA approval to make it easier to get new antibiotics approved. The GAIN (Generating Antibiotic Incentives Now) ACT, passed in 2012 as part of a larger law, provides an additional five years of patent protection for certain antibiotics and makes them eligible for fast-track review by the FDA.
Congress is currently considering the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which offers companies an even easier pathway to FDA approval for antibiotics used by "a limited population of patients" who urgently need new drugs. But ADAPT contradicts that purpose by specifying that doctors have the authority to prescribe these drugs for any patient under any circumstances. The bill also encourages FDA to approve these drugs based on smaller studies, Phase 2 rather than controlled Phase 3 trials, and surrogate endpoints rather than meaningful health outcomes.
In contrast, the Center for Disease Control and Prevention has stated that, "Perhaps the single most important action needed to greatly slow down the development and spread of antibiotic resistant infections is to change the way antibiotics are used." Unfortunately, neither GAIN nor ADAPT does anything to discourage the overuse of new or old antibiotics.
Human misuse includes prescribing antibiotics for colds, flu and other viral infections for which antibiotics are ineffective. It also includes widely prescribing new antibiotics when older antibiotics would be just as effective, instead of saving new antibiotics for when they are most needed. Changing doctors' prescribing habits is difficult, however, despite recent efforts such as the "Choosing Wisely Campaign."
The most important issue missing from these legislative efforts isn't human-centered at all—it is the routine use of antibiotics in animals. The FDA reports that 80 percent of antibiotics in the U.S. are used for food-producing animals, not for humans, and that many are used to promote animal growth in cows, sheep, chickens and hogs, rather than to keep them healthy. The resulting resistant bacteria can spread from animals to humans. And yet, a bill to address that problem, introduced by Rep. Louise Slaughter and other House members in every Congress since 1999, has never had a hearing or vote in the House. Nor has Sen. Dianne Feinstein's recent companion bill in the Senate. In fact, a much weaker bill introduced by Rep Henry Waxman last year, which would merely require data collection on use in farm animals, attracted only 10 co-sponsors and never had a hearing, vote or Senate companion bill.
Provisions to reduce human misuse of antibiotics were in the GAIN Act, but deleted before it was passed. Earlier this year, the FDA proposed strategies to reduce the use of antibiotics in livestock—unfortunately, they are voluntary and unenforceable.
Last month, however, the President's Council on Advisors on Science and Technology issued a report on antibiotic resistance that takes a very different approach than Congress or the FDA. Rather than focusing on financial incentives and reducing the research burden on pharmaceutical companies, this report includes a range of scientific insights and strategies about what kind of research is needed to develop antibiotics that will save lives. The challenge now is to translate those complex and evidence-based ideas into a bill that can pass Congress.
Opinions expressed in this blog are those of the author and are not necessarily the opinions of AAAS, its officers, general members, and/or AAAS MemberCentral department or staff.