Rogers / 5 Senator Adams

S.S._____

A BILL
To allow all terminally ill patients to gain access to experimental drugs prior to their FDA approval.
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Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE
This act may be cited as the Expansion of Experimental Drugs Act of 2015.
SECTION 2. FINDINGS
Congress hereby finds and declares that,
1) Legislation approved or pending in more than 20 states allows terminally ill patients to access drugs that have not
been approved by the Federal Drug Agency.
2) Ongoing clinical trials only have room for a fraction of the number of people who stand to benefit from the
drug once its shown to be safe and effective.
3) Withholding experimental drugs from the most gravely ill has fueled several states to pass so called right-to-try legislation that would make these drugs available without FDA approval for terminally ill patients with no
other options.
4) The Tufts Center for the Study of Drug Development says it normally takes 5.5 to 10.5 years for a drug to
receive FDA approval.
5) Colorado, Missouri and Louisiana all passed right-to-try legislation this year that would enable those with
terminal illnesses and no other treatment options to secure investigational drugs after their first phase of clinical
trials (there usually are at least three) before final FDA approval if the drug manufacturer is willing to provide
them.
6) Under FDA rules for drug testing, Phase One, the first studies to use human subjects, is quite limited in the
number of patient participants typically 20 to 80.
7) The FDA receives about 550 applications a year from drug companies to supply drugs to individuals before
final approval and agrees to nearly all of them.
8) Expanded access, also called compassionate use, provides a pathway for patients to gain access to
investigational drugs and medical devices for serious diseases or conditions.
9) Only three percent of patients today are enrolled in clinical trials; for everyone else, their only hope for obtaining
potentially life-saving medications is to ask the FDA for special permission.
10) Right-to-try expands access to potentially life-saving treatments years before patients would normally be able to
access them.
11) Since early 2014, more than 20 states have introduced so-called "right-to-try" bills in the hopes of allowing
terminally ill patients to access experimentaland potentially life-savingtreatments more easily.
SECTION 3. STATUTORY LANGUAGE
A) Experimental drugs shall hereby become available to patients diagnosed with terminal illnesses prior to their
FDA approval. This will remove the lengthy application process to receive the drugs. Experimental drugs shall
hereby extend to patients of all ages who have been formally diagnosed, to all Americans who are legal residents
to the United States of America, regardless of medical histories. All states must hereby follow these regulations
and allow for patients to experiment with these drugs. The parameters by which all qualifying patients must
possess will be decided by the FDA and approved by Congress.
B) Drugs shall be distributed to the patients as soon as they are available, given that a compromise can be made
between the patient, the company of the experimental drug, and the insurance company of the patient. The
financial cost of the use and access to these drugs by patients will be endorsed by the Department of Health. The
patient must have a serious or immediately life threatening disease or condition, have no comparable or
satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition, and be unable to obtain the
investigational drug under another IND or to participate in a clinical trial.
C) The Expansion of Experimental Drugs Act shall be enacted immediately. It shall be renewed every 10 years.