WASHINGTON, D.C. – U.S. Senator Jim Inhofe (R-Okla.) today joined Senator Sam Brownback (R-Kan.) in introducing legislation to allow seriously ill patients to access potentially life-saving investigational treatments, without the bureaucratic delays that currently limit the availability of many of these treatments.
The Access, Compassion, Care and Ethics for Seriously ill Patients Act (ACCESS Act) would offer seriously-ill patients a three-tierd approval system through the Food and Drug Adminstration (FDA) for treatments showing efficacy during clinical trials.
“Almost every American has a family member or someone close to them who has suffered from cancer or other chronic diseases and have been left frustrated at the lack of innovative treatment options,” Senator Inhofe said. “New technologies and scientific breakthroughs are being made daily in medicine, offering potentially life-saving treatments for previously untreatable terminal illnesses. Americans deserve access to these breakthrough treatments, but unfortunately, bureaucratic restrictions and regulations often delay their availability, sometimes preventing terminally ill patients from ever having the chance to undergo these promising clinical trials.
“These unnecessary delays can not be allowed to be the cause of one more American dying from a disease when there exists a potentially viable treatment.”
The legislation allows for compassionate investigational access drugs to be covered by Medicare through a five-year demonstration project. The bill also makes a technical correction that would allow Medicare Part D plans to cover more off-label drugs uses on a patient-by-patient basis if it is deemed medically necessary. Currently, Part D plans may cover drugs used off-label only if the drug’s use is published within one of three medical abstracts.
Senator Inhofe also co-sponsored this legislation in the 109th Congress.