Res. No. 478
Title
Resolution calling on the United States Congress to pass, and the President to sign, a bill which requires expanding access to breakthrough drugs for individuals with all serious diseases.
Body
By Council Member Holden
Whereas, The United States (U.S.) Food and Drug Administration (FDA) defines a serious disease or condition as a disease or condition associated with morbidity that has substantial impact on day-to-day functioning, yet the morbidity need not be irreversible, provided it is persistent or recurrent; and
Whereas, Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one; and
Whereas, The FDA defines a "breakthrough drug" as one that is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints; and
Whereas, The FDA will expedite the development and review of breakthrough drugs; and
Whereas, The FDA's Center for Drug Evaluation and Research (CDER) has received 64 breakthrough therapy designation requests since October 2017, and has granted 23 applications, including for a drug which helps individuals with cystic fibrosis and one for individuals with human immunodeficiency virus type 1 (HIV-1); and
Whereas, Thousands of New Yorkers are living with serious diseases; and
Whereas, According to the American Cancer Society, an estimated 110,800 New Yorkers across the state have been diagnosed with cancer in 2018; and
Whereas, According to the Department of Health (DOH), the crude rate of deaths resulting from all invasive malignant tumors is 141.8 p...
Click here for full text