The Culture of Antibiotics Regulation

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Scholars discuss the challenges of promoting antibiotic development and preserving existing drugs.

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This past year, scientific innovation and flexible regulation have allowed for a multifaceted response to the coronavirus pandemic. But looking ahead, is the scientific community prepared for a bacterial outbreak?

Scientists across the globe are raising alarm bells that antibiotic resistance is reaching dangerous levels. This phenomenon occurs when bacteria develop the ability to survive exposure to the drugs designed to kill them. According to the Centers for Disease Control and Prevention, at least 2.8 million people in the United States are infected with antibiotic-resistant bacteria each year, leading to more than 35,000 deaths. The crisis is only growing more severe—one study found that incidents of antibiotic resistance have doubled in the past 20 years.

Regulation can play a key role in responding to this threat.

First, regulators can create incentives that preserve the effectiveness of existing antibiotics. Misuse and overuse of antibiotics—both in patients and in livestockaccelerate the development of antibiotic resistance. The National Action Plan for Combating Antibiotic-Resistant Bacteria describes several ways in which state and federal agencies are working to promote the responsible use of antibiotics, such as the requirement that hospitals develop antibiotic stewardship programs. In addition, earlier this year, the U.S. Food and Drug Administration (FDA) sought public comment on its preliminary proposal to limit the duration of antibiotic use in livestock.

Second, regulation can promote the development of new antibiotics to tackle resistant strains. Antibiotic development has plummeted since its peak in the 1950s; in fact, pharmaceutical companies have failed to develop any new class of antibiotics in over 30 years. One reason for this “discovery void” is that developing new antibiotics is not particularly profitable, which pushes firms to pursue more lucrative projects. In 2012, the U.S. Congress passed the Generating Antibiotic Incentives Now Act in an attempt to increase the profitability of antibiotic development by extending market exclusivity by five years. Although the Act contributed to some new drug development, FDA acknowledged that the antibiotic pipeline remains “fragile” and that more incentives are needed to close the development gap.

The dangers of antibiotic resistance are more salient now than ever. In the early stages of the pandemic, antibiotics were commonly prescribed to COVID-19 patients. Experts warn that the overuse of antibiotics among those patients has exacerbated the problem of antibiotic resistance. Moreover, patients who have extended hospital stays are at increased risk of contracting an antibiotic resistant infection.

In this week’s Saturday Seminar, experts explore how regulatory reforms can address the crisis of antibiotic resistance.

  • Public policies designed to address antibiotic resistance involve difficult moral tradeoffs, Jonathan Anomaly of the University of Pennsylvania argues in an article published in the Georgetown Journal of Law & Public Policy. Anomaly explains that in both the medical and agricultural industries, people tend to overuse antibiotics because the benefits are felt on the individual level while the costs are dispersed across the population. Anomaly suggests that policymakers can address this collective action problem by implementing user fees on antibiotics, which can in turn fund research on antibiotic development, diagnostic tests, and new vaccines. Anomaly also supports the use of transferable vouchers to promote new antibiotic development. Under this program, firms could extend market exclusivity for another drug it manufactures in exchange for producing new antibiotics.
  • In an article in the Food and Drug Law Journal, Jonathan J. Darrow, Michael S. Sinha, and Aaron S. Kesselheim of the Program on Regulation, Therapeutics, and Law argue that the incentives provided by patent law do not align with the structure of the antibiotic market. Darrow, Sinha, and Kesselheim explain that patents provide incentives for markets that have high profit potential and a large consumer base. Treatments and cures for infectious diseases, however, have lower profit potential due to public and governmental pressure to lower costs and a consumer base that shrinks as disease spread decreases. The authors support initiatives backed by government funding and argue for “advance market commitments” to purchase set amounts of new drugs to counter the effects of profit-limiting legislation.
  • The existing patent law regime recognizes only a small fraction of the intellectual work required to create and maintain the value of drugs that treat antimicrobial-resistant infections, argues Gregory Salmieri of the Salem Center for Policy. In an article published in the George Mason Law Review, Salmieri notes that antibiotic treatments require continued intellectual developments over time. Furthermore, he suggests that current policy solutions fail to stimulate both the development and stewardship of new antimicrobials. Salmieri recommends that policymakers address the issue by implementing a new property right for antibiotics. This right would function like a patent but could be indefinitely renewable so long as a drug remains effective.
  • In an article published in the Annals of Health Law and Life Sciences, Donna (Hanrahan) Gambaccini describes federal efforts to curb antibiotic resistance. Gambaccini criticizes the Obama Administration’s creation of a Task Force for Combating Antibiotic-Resistant Bacteria and other similar measures as “feel good actions without statutory and regulatory teeth.” Gambaccini urges FDA to establish a Risk Evaluation and Mitigation Strategy that would limit the prescription of certain antibiotic drugs to situations where they are clinically necessary, which would prolong the lifespan of antibiotics. Gambaccini also calls on Congress to pass a new drug approval pathway specifically for antibiotics with reduced clinical trial requirements.
  • If food producers continue to deliver antibiotics to food-producing animals in ways that breed antibiotic resistance, those drugs will rapidly lose their effectiveness, argues Emilie Aguirre of Duke Law School. In an article published in the Food and Drug Law Journal, Aguirre suggests that the global nature of the food system requires that countries adopt an international approach to regulating the misuse of antibiotics in food-producing animals. Aguirre recommends a “democratic experimentalist” regime that would organize data collection and inform the standards produced by the World Organisation for Animal Health. According to Aguirre, this model would produce the collective effort necessary to reduce the “subtherapeutic” use of antibiotics in animals.
  • Top-down command and control regulation cannot adequately address antibiotic resistance in low-income and middle-income countries, argues Gerard Porter of the United Kingdom’s University of Edinburgh School of Law and coauthors in an article published in BMJ Global Health. Instead, more flexible regulatory principles called “smart regulation” can supplement and improve upon traditional approaches, according to Porter and his coauthors. “Smart regulation” aims to promote regulation by outside parties and establish a “regulatory enforcement pyramid” with progressively serious penalties for violations. For example, Porter and his coauthors propose a system in which pharmacies selling antibiotics without a prescription could receive a warning, followed by a fine, and then face temporary closure or even criminal charges.

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.