Last week, Senate approved legislation that would authorize patients, who have been given a year or less to live the right to try experimental drugs without FDA approval. Vice President Mike Pence strongly backs the legislation, which is also being considered in Congress.
State Senator Bryan Simonaire, Republican from Pasadena, said it “gives hope where none exists.”
In a letter, a representative of Johns Hopkins Medicine — a hub for biomedical research — stated the institution has concerns the bill could “make it more difficult and complicated for patients to receive potentially life-saving investigational treatments.”
According to the Goldwater Institute, a total of 33 states have enacted similar laws, while 17 other states, including Maryland are considering legislation. The bill written by the Goldwater Institute is being utilized by Maryland and other states.
Under Maryland’s proposal, critically ill patients would be able to bypass the U.S. Food and Drug Administration (FDA) to access experimental medicines that have completed Phase I testing. According to the FDA, during this phase, drugs are tested for safety and dosage levels are determined. Subsequent phases test the drug’s side effects and efficacy. While 70 percent of the drugs will pass Phase I testing, only a quarter or third of those will be approved in the later phases.
Eligibility would depend on doctor recommendation and all approved treatment options had been exhausted. Also, a waiver would need to be signed by the patient to clear the insurer from any responsibility to pay for treatments. Patients would also need to try to join any open clinical trial, before moving to pursue the drug independently.
A revision of the measure will require health care insurers to continue the same standard of care, prior to the patient starting the experimental treatment. The eligibility standards set by hospice organization will not change under the proposed bill.