NAPSR News: A new bill has been proposed to streamline U.S. regulatory approvals for antibiotics

WASHINGTON - Dec. 11, 2014 - PRLog -- A new bill has been presented by U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT)  to develop a new pathway for antibiotic drug approvals called the Promise for Antibiotics and Therapeutics for Health (PATH) Act .This act is anticipated to streamline access and promote research and development for lifesaving antibiotics for patients, especially for veterans who are prone to antibiotic-resistant bacteria while overseas. According to the Department of Defense, ‘superbugs’ or anti-biotic resistant bacteria have affected more than a third of returning Iraq and Afghanistan veterans.

“Antibiotic-resistant bacteria pose serious and unique challenges to health care professionals,” Bennet said. “This bill will allow new antibiotics that show promise combating these bacteria to reach patients more quickly and save lives. It will also encourage bioscience companies to invest in innovative research to develop these lifesaving drugs.”

“By addressing antibiotic-resistant bacteria, we can make major strides in preventing a significant number of illnesses and deaths in the United States,” Senator Hatch said. "I am excited to build on the progress we have made. The PATH Act is needed to spur the innovation of new antibiotics and give patients with unmet medical needs access to important antibiotics faster.”

A new study in the UK suggested that due to the looming presence of antimicrobial resistance an estimated 10 million individuals will die from drug resistance infections by 2050. The implementation of the (PATH) Act aims to accelerate FDA Approval for antibacterial drugs ‘for an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need.” The bill also mandates, a special designation from the FDA be indicated on the approved drug’s label outlining use in limited, high-risk populations approved under this pathway.

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The NAPSRx® is a trade association for pharmaceutical sales reps, sales managers and sales trainers who work in the pharmaceutical industry. NAPSRx® provides Continuing Medical Education to its members as well as CNPR® Certification to candidates who look to enter a pharmaceutical sales career. The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals.

The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®.
Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information or visit the website at http://napsronline.org/.