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Texas, North Carolina, Consider Expanding Lifesaving Drug Access

June 25, 2019

As terminally ill patients exhaust approved options for treatments that could extend or save lives, Texas and North Carolina are taking steps to expand access for citizens suffering from serious chronic illnesses.

Recently introduced bills in those two states would expand access to treatments not currently approved by the Food and Drug Administration (FDA). Both states have right-to-try laws that allow terminally ill patients access to experimental procedures and treatments not yet approved by the FDA.

House Bill 805, filed by Texas Rep. Tan Parker (R-Flower Mound) on January 24, would expand the state’s right to try law to permit patients with severe chronic diseases to use drugs, biological products, and devices not yet granted FDA approval. Like terminally ill patients, “patients who are batting a severe chronic disease that is debilitating or causes severe pain do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval from the United States Food and Drug Administration,” the bill states.

In North Carolina, a bipartisan coalition of four sponsors and ten cosponsors introduced House Bill 934 on April 16. In addition to expanding right to try to patients with serious chronic illnesses, the bill would allow patients to access stem cell treatments not yet approved by the FDA. On May 2, the North Carolina House unanimously passed the bill and moved it to the Senate for consideration.

Moral, Medical Justifications

A sponsor of the North Carolina bill, Rep. Hugh Blackwell (R-Raleigh), says right to try laws are both morally and medically justified.

“It simply seems somewhat heartless to deny a potentially saving treatment while that treatment undergoes further testing to determine its effectiveness or safety,” said Blackwell. “In the case of those the initial legislation sought to benefit, if an experimental treatment is ineffective or unsafe, they seem hardly able to be worse off,” said Blackwell.

States Drive Change

The federal Right to Try law went into effect on May 30, 2018, and states continue to advance legislation to help suffering patients by extending right to try beyond the federal law. Blackwell recognizes that our system of government allows states, subject to the constraints of the Constitution, “to experiment governmentally in areas not exclusively the province of the federal government.”

“In this instance, thus, North Carolina can express its views in an area that affects the wellbeing of its citizens, perhaps encouraging the federal government to move forward in similar fashion at its level,” said Blackwell. “This appears to be what happened with the recently passed federal tight to try legislation, passed after many states had already taken similar action.”

FDA Obstacles

Christina Herrin, campaign manager for Free to Choose Medicine, an initiative of The Heartland Institute, which publishes Health Care News, says North Carolina is moving in a positive direction to broaden the scope of the current right to try law, though the federal government stands in the way of needed reforms.

“Casting a larger net will allow more patients access to potentially lifesaving treatment,” said Herrin. “But it still doesn’t address the root of the problem: the antiquated drug approval process. It still takes 12 years and 2.9 billion dollars to get a drug from lab to market. Too many patients are waiting and dying while the FDA bureaucracy churns,” said Herrin.

 In Texas, H.B. 804 explicitly recognizes the problems with the onerous FDA approval process, with the bill stating “the standards of the United States Food and Drug Administration for the use of investigational drugs, biological products, and devices may deny the benefits of potentially life-altering treatment to patients with a severe chronic disease.”

Building a Parallel Track

Herrin says the FDA should implement an enhanced “parallel track” to augment the FDA approval process.

“Parallel track was used in the '80s to create access to lifesaving treatment for more than 12,000 AIDS patients who would have otherwise died,” said Herrin. “We need to expand parallel track to include more diseases and more patients. Patients who may not have 12 years to wait for drug approval will get quicker access to cutting-edge drugs, and their experience with the drugs would supplement the standard clinical process.”

Blackwell says the proposed reforms would give terminally ill patients and those with a serious chronic illness the power to choose treatments without government interference.

“Moreover, in those circumstances, allowing a patient to make the choice seems not only reasonable but an appropriate occasion for personal choice, once made known of possible side effects and consequences, both known and unknown, by medical providers,” said Blackwell.

Kelsey E. Hackem (khackem@gmail.com)writes from Washington.

 

Official Connections:

North Carolina state Rep. Hugh Blackwell (R-Raleigh)

https://www.ncleg.gov/Members/Biography/H/580

Texas state Rep. Tan Parker (R-Flower Mound)

 https://house.texas.gov/members/member-page/?district=63