Today, Representatives Scott Peters (D-CA), Morgan Griffith (R-VA), & Michael McCaul (R-TX) introduced H.R. 2090, the bipartisan "Patient Choice Act of 2013,' which allows the terminally ill to purchase drugs that have received preliminary approval from the Food and Drug Administration (FDA), thereby increasing patient access to cutting-edge therapies. Many companies are currently moving overseas because of the lengthy lag-time between submitting a drug to FDA and getting approval.
"There are research facilities in San Diego developing potentially life-saving medicines and therapies, which have been proven safe after rigorous testing. Unfortunately, because of the lengthy FDA approval process, patients with the most urgent need aren't able to access them," Congressman Peters said. "We should be doing more to promote research and innovation here in the United States, and this bill is a way to incentivize researchers to stay here while getting patients remedies that they need."
Congressman Peters continued, "I am proud to work across the aisle with my colleagues, Mr. Griffith and Mr. McCaul, to introduce this bipartisan bill that can fully utilize the high quality research that we're doing in San Diego for the betterment of patients across the country."
Given the burdensome approval process currently in place at the FDA for new medicines, many patients do not have access to drugs that could save their lives. This bill provides an avenue for the FDA to fast-track the provisional approval processes for drugs that are deemed safe or are approved in select "listed countries' in Europe already. Drugs given provisional approval would be available to consenting patients with terminal illnesses, while the drug continues through the standard process toward full FDA approval.
"Patients and their physicians need and deserve options as they battle deadly diseases," Rep. Griffith said. "For patients whose doctors have exhausted current medical options and have been told that the end of life is nearing, why should the federal government interfere if the patient wishes to spend their own money on an experimental treatment plan? The Patient Choice Act would empower a patient faced with that dilemma to help move the ball down the field in the area of medical science and medical knowledge. In rare cases, the individual may be cured or the patient's life lengthened. But even when that doesn't occur, the individual will have the satisfaction of knowing that they helped save someone in the future."
"The Patient Choice Act offers hope to patients by giving them more treatment options and control over their own health decisions, said Congressman McCaul, Chairman of the Childhood Cancer Caucus. "I am particularly proud to support legislation which will spur the development of much needed treatments for children with cancer and other rare disease for which there are few treatment options available."