U.S. Senator Pat Roberts (R-Kan.) today voted to improve pediatric drug and device research, incentivize antibiotic research and help address critical drug shortages --especially common in rural areas like in Kansas.
Roberts voted for the Food and Drug Administration (FDA) Safety and Innovation Act which included several provisions he supported as a member of the Senate Committee on Health, Education, Labor and Pensions.
"This bill contains provisions to advance medical research specifically for children, to address drug shortages and to expedite development of antibiotics to better fight infectious disease," Roberts said. "It will help address critical deficiencies in our health care delivery system while improving much needed medical research in America."
In addition to reauthorizing the user fee agreements, the bill, S. 3187, includes The Better Pharmaceuticals and Devices for Children Act, cosponsored by Senator Roberts, to permanently extend programs to ensure medications are effective and safe for children by providing an incentive for pharmaceutical companies to invest in pediatric research while providing predictability and accountability for pediatric drug and medical device development.
Since the enactment of these programs, approximately 426 drug labels have been revised with important pediatric information and the number of "off-label" drugs used in children has declined from 80 to 50 percent. There was also a five-fold increase in the number of small-market medical devices designated for pediatric use.
The legislation also includes the Generating Antibiotic Incentives Now Act (GAIN), cosponsored by Sen. Roberts, which boosts development of products to treat serious and life threatening infections. It provides meaningful market incentives and reduces regulatory burdens to encourage development of new antibiotics.
According to FDA, the approval of such drugs has decreased by 70% since the mid-1980s. The development of just one new antibiotic can take upwards of ten years.
The legislation includes requirements for reporting on drug shortages and also provides transparency and accountability to help determine the reason for the particular shortage.
"When I am back in Kansas talking to folks about health care, I often hear about the problem with drug shortages," Roberts said. "As difficult as it is to hear from my hospital administrators and pharmacists in Kansas about the difficulties they are having in getting drugs to fill prescriptions for patients, nothing compares to the patients and families of patients who can't get their drugs; who can't get their treatment; who are already scared about the future; and now can't get their lifesaving medication due to a shortage. This bill should help these folks sleep a little better at night."
The bill was approved by the Senate with a vote of 92 to 4.