Pharmaceutical Companies Call for Incentives for New Antibiotics
By: Cohen, Placitella & Roth @ Jun 06, 2016
So-called “superbugs,” or antibiotic-resistant bacteria, are a widespread and growing international problem. These bacteria no longer respond to the antibiotics designed to destroy them, making the infections they cause more deadly and difficult to treat. Many of these infections occur in hospitals, and the Philadelphia area is not immune. According to the Centers for Disease Control and Prevention, nearly 2 million Americans each year are infected with these superbugs, and at least 23,000 deaths each year are a direct result of these infections. Now, a number of international pharmaceutical and diagnostic companies are calling for governments to offer economic incentives to encourage the development of new antibiotics needed to fight bacteria that have grown resistant to existing medications.
The World Economic Forum declaration
As reported by the New York Times, more than 80 of the world’s drugmakers and diagnostic companies released a declaration at the World Economic Forum in Davos calling for governments to work with companies to fight the problem of antimicrobial resistance. Signatories to the declaration include AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, and others.
Fewer and fewer new antibiotics have been developed over the past few decades, in part because pharmaceutical companies no longer find such work sufficiently profitable. Antibiotics are generally used for short periods of time to treat infections, and sell at low cost. Drug companies find it much more lucrative to focus on new drugs to treat cancer or other chronic conditions, which sell for more money and are used over longer periods of time. Through the declaration, the companies are calling for:
- Reimbursement for developing antibiotics that better reflects their true value to society, as well as the costs of their development;
- New “transformational commercial models” to encourage development and cut down on unnecessary antibiotic use, one of the leading causes of antibiotic resistance; and
- Better use of diagnostic tests to more quickly identify infecting organisms. This will help to ensure that antibiotics are not being used to treat a viral infection, for which they are ineffective.
The GAIN Act
The U.S. has already begun to implement new incentives for antibiotic development. In 2012, President Obama signed into law the Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act. The GAIN Act contains the following provisions to spur development of new antibiotics:
- An additional five years of market exclusivity for new qualified antibiotics, meaning that the drug’s manufacturer enjoys more years of exclusive drug sales before generic equivalents will be available;
- Expedited and priority review and approval from the FDA for qualified drugs;
- Additional guidance from the FDA on the development of antibiotics that target specific bacteria, which has not been previously available; and
- A mandate for the FDA to prepare a list of “qualifying pathogens” with the potential to pose a serious threat to public health.
Contact a Philadelphia medical malpractice lawyer
Superbug infections can often be caused by a hospital or medical professional’s failure to take appropriate precautions. If you or a family member have suffered an antibiotic resistant infection, or if you have endured the tragedy of losing a loved one to such an infection, you may be able to recover for your loss. Reach out to the Philadelphia attorneys of Cohen, Placitella & Roth PC to learn more.