Repairing the Antibiotic Pipeline: Can the Gain Act Do It?

• Citation: Vol. 9 No. 1
• Publication year: 2013

Washington Journal of Law, Technology and Arts Volume 9, Issue 1 Summer 2013

Repairing THE Antibiotic Pipeline: Can THE GAIN Act Do It?

Caitlin Forsyth(fn1)© Caitlin Forsyth

ABSTRACT

Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance problem. There are, however, areas of promise in the Act that may mitigate its shortcomings and pave the way to the possibility of the Act's success.

TABLE OF CONTENTS

Introduction ...................................................................................... 2

I. The Need for the GAIN Act ..................................................... 4

II. The GAIN Act's Incentives ...................................................... 6

A. The Act Adds Exclusivity Periods to Qualified Antibiotics .......................................................................... 6

B. The Act Provides for Priority Review and Fast-Track Approval of Qualified Antibiotics ...................................... 8

C. The Act Creates a Study on Incentives for Qualified Infectious Disease Biological Products .............................. 8

III. The GAIN Act's Problems ....................................................... 9

A. The Act is Void of Meaningful Antibiotic Conservation Incentives .......................................................................... 10

B. The Act Will Likely Increase Healthcare Costs ............... 12

C. The Act's Incentives Are Likely Not Enough to Incentivize Pharmaceutical Companies to Undertake Costly and Risky Research and Development ................. 13

D. The Complicated and Oft-Maligned FDA Drug Approval Process Remains Largely Unchanged .............................. 14

IV. Areas of Promise in the GAIN Act ......................................... 15

A. The Act's Antibacterial Drug Development Task Force May Address Some of the IDSA's Proposals Not Expressly Adopted in the Act ........................................... 15

B. The Act's Recognition of Biologics as Another Solution to the Antibiotic Resistance Problem is Promising .......... 16

Conclusion ..................................................................................... 17

Practice Pointers ............................................................................. 18

INTRODUCTION

Antibiotic resistance is a worldwide epidemic. It is an acute domestic problem, as well. In 2006, methicillin-resistant Staphylococcus aureus (MRSA) killed more Americans (19,000) than emphysema, HIV/AIDS, Parkinson's disease, and homicide combined.(fn2) Furthermore, "[a]lmost 2 million Americans per year develop hospital-acquired infections (HAIs), resulting in 99,000 deaths, the vast majority of which are due to antibiotic-resistant pathogens."(fn3)

Antibiotic resistance and the lack of activity along the antibiotic development pipeline are problems worthy of Congress' attention. Existing antibiotics are losing their effectiveness due to antibiotic resistance and yet, antibiotic development efforts are slow to respond to this crisis. Antibiotic development is stunted because the pharmaceutical companies spearheading research and development are primarily concerned with maximizing profits and feel the scientific and economics challenges are not worth the investment. Antibiotics are typically not profitable for pharmaceutical companies because they are prescribed sparingly to stem antibiotic resistance.(fn4) Moreover, consumers only purchase small quantities of antibiotics as they are typically used for 7-14 days, whereas some profitable pharmaceuticals are taken for the duration of the consumer's life.(fn5)

Congress diverted its attention to the problem and recently passed the GAIN (Generating Antibiotic Incentives Now) Act. The GAIN Act incentivizes pharmaceutical companies to develop antibiotics. However, the GAIN Act's many incentives for antibiotic research and development are unlikely to repair the antibiotic pipeline and stem the problem of increasing antibiotic resistance.

Part I of this Article will discuss why Congress felt the need to implement the GAIN Act. Part II will discuss the Act's incentives for antibiotic development. Part III will discuss the Act's potential problems and explain why it may not repair the antibiotic pipeline. Part IV, however, will address potential areas of promise in the Act and will suggest how these provisions may mitigate the Act's problems.

I. THE NEED FOR THE GAIN ACT

Antibiotic resistance occurs when bacteria become resistant to antibiotics after being exposed to them.(fn6) This resistance is often due to a spontaneous gene mutation during bacterial cell replication that allows a cell to continue to divide and replicate, unlike its counterparts that were killed off by the antibiotic.(fn7) Increased antibiotic use correlates to a rise in antibiotic resistance because antibiotic use exacerbates natural selection of antibiotic-resistant bacteria.(fn8) Antibiotic resistance due to overuse is an increasing problem in the United States due to (1) the inappropriate use of antibiotics, when physicians prescribe antibiotics without first determining whether a patient has a bacterial infection that can only be cured with antibiotics; (2) the increased presence of antibiotics in our food supply, which potentially introduces more antibiotic-resistant bacteria into the human population; and (3) the extensive use of antibiotics in hospitals.(fn9) Because hospitals frequently prescribe antibiotics for patients, hospitals are prime breeding grounds for antibiotic-resistant bacteria.

The social and economic impact of antibiotic resistance is enormous and cannot be ignored. "Each year, antibiotic-resistant infections are responsible for tens of thousands of deaths, hundreds of thousands of hospitalizations and up to $26 billion in extra costs to the U.S. health care system."(fn10) For example, antibiotic resistant infections (ARIs) increase patient care costs and wage losses because ARIs typically lead to hospital stays that are up to two weeks longer than they would be if the patients had not contracted ARIs.(fn11) Alliance for the Prudent Use of Antibiotics, a nongovernmental organization, suggests that a mere 20% reduction in antibiotic resistant infections would save up to 5.2 billion U.S. healthcare dollars a year.(fn12) Despite the extent of the problem, few pharmaceutical companies are willing to devote the time and resources to antibiotic development.

There are several reasons why pharmaceutical companies are reluctant to pursue new antibiotics. One reason is that antibiotic development poses unique scientific challenges. For example, over a 10-year period, it took 72 candidate antibiotics to yield one FDA-approved product, whereas other pharmaceuticals required only 15 candidates to yield an FDA-approved product.(fn13) Drug development is facing increasing economic challenges-it currently costs $400- $800 million per approved agent.(fn14) Further, there are fewer perceived economic incentives for pharmaceutical companies to develop antibiotics than other drugs. Antibiotics do not generate as much revenue as other...