GAIN Act Gives Pharmaceutical Companies Incentive To Make First New Antibiotics In 15 Years: Antibiotic Resistance Fight Continues
Dr. Margaret Chan, director-general of the United Nations World Health Organization, warned that the world faces a post-antibiotic apocalypse. Chan foretold that we will experience "... an end to modern medicine as we know it. Things as common as strep throat or a child's scratched knee could once again kill. Some sophisticated interventions, like hip replacements, organ transplants, cancer chemotherapy, and care of preterm infants, would become far more difficult or even too dangerous to undertake," says Forbes.
In a world where antibiotic resistance is becoming a growing issues, only nine new antibiotics have been approved by the Food and Drug Administration (FDA) in the past 15 years. In a recent survey of the development programs of the largest drug companies, only five new antibiotics were under development and none of them had new mechanisms of action, meaning they treated infections the same way old and increasingly ineffective antibiotics do presently.
One of the world's most pressing threats is antibiotic resistance. The drugs are important tools in fighting off life-threatening bacteria-based diseases, but they are commonly used to treat minor afflictions like sinusitis and common colds. This use, when not absolutely necessary, allows bacteria to gain strength — as the antibiotic kills less harmful bacteria, the few which survive can continue to proliferate and escape the drug's effects if administered again.
Often, we feel that medicines will always work as long as we take them when we are told. However, when a medicine, like an antibiotic, depends on another organism for its efficacy, issues with drug use and overuse can arise.
Generating Antibiotics Incentives Now (GAIN) Act, a bill politicians hope to pass, will give pharmaceutical companies more incentive to develop new and effective antibiotics. It will also require the FDA to give antibiotic approval and testing priority over other tasks. The instance of antibiotic-resistant infections is increasingly affecting Americans, particularly children and the elderly.
However, pharmaceutical companies have put a lot of focus on making drugs to manage chronic issues like high cholesterol, dementia, arthritis, psychological disorders, and heart disease. Such drugs are often highly profitable, as users need to take more of them, often once or twice daily. whereas antibiotics are taken for a short amount of time, usually a maximum of 10 days. Similarly, there have been many efforts put into place to reduce the prescription of antibiotics in the effort to reduce likelihood of resistance, but this is not favorable for pharmaceutical companies, who rely on the sale of these drugs to make profits.
However, the damage has already been done. PatentDocs estimated 50 percent of Staphylococcus bacterial infections, which can cause abscesses of the skin and food poisoning, are already resistant to many antibiotics on the market. On the same note, 15 percent of Acinetobacter infections, which can infect people with compromised immune systems, are resistant to all forms of treatment currently available.
The current problem and reason for why new drugs are not being made is the losses pharmaceutical companies must face in order to make them. Antibiotic development, before this act, was often not profitable because of resistance and lack of use.
The GAIN Act hopes to give pharmaceutical companies incentives to create new antibiotics to fight these dangerous and resistant bacterial infections. These incentives include market exclusivity for five years: if a pharmaceutical company successfully makes a new drug, that company will have the right to be the sole provider of that drug for five years, with no generics available. Not only is this promising for the companies, who will likely make great profit, but these drugs can also potentially save millions of lives.