Lives hang in the balance while the FDA bureaucracy churns – Washington Examiner

The McLinn family of Indianapolis is still fighting for their seven-year-old son, Jordan, who was diagnosed at the age of 3 with Duchenne muscular dystrophy. This is an aggressive disease that results in muscle weakness and loss first attacking the extremities, eventually moving to the heart and other internal organs. There is no known cure, yet, but there are treatments that can help manage symptoms and slow progression of the disease.

For people like Jordan McLinn, failure or needless delay of the Food and Drug Administration to grant a compassionate use request (also known as expanded access) can mean the difference between walking or being wheelchair-bound.

Currently, the FDA has the authority to not approve access to potentially life-saving medicine based on the agency's criteria meaning, the FDA must determine that "the potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated."

In a country that prides itself on upholding individual liberties, it's contradictory that the government reserves the right to grant or deny individuals who are fighting for their lives access to potentially life-saving medicine simply based on the agency's perspective calculation of what is reasonable or not.

Time for a reality check: There is nothing reasonable about being diagnosed with a terminal illness.

Acknowledging the transformative nature of technology and medicine, there is an immeasurable benefit to removing an inadequately-run government barrier from the equation. Someone who is fighting for their life should not also have to battle the government for access to potentially life-saving medicine. Their lives hang in the balance while the bureaucracy churns. Not to mention, it takes an average of 10 years for a new drug to reach the final approval stage before it is legally sold, prescribed, or marketed.

For Jordan and many others, this is too late.

In cases where no other alternatives exist, it is inhumane to not allow terminally-ill patients to access medical treatment. "Right to try" has passed in 37 states, from liberal states such as California and Illinois to conservative states such as Georgia and Texas.

At the federal level, there is bipartisan support in both chambers. The Trickett Wendler Right to Try Act, S. 204, sponsored by Sen. Ron Johnson R-Wis., accompanied by 46 co-sponsors, passed the Senate last week by unanimous consent. Terminally-ill patients who reside in states that have already passed right to try laws wouldn't have to worry about federal bureaucrats interfering. The states would have the power to supersede federal restrictions.

For patients who have exhausted all other options, right to try could be a matter of life or death and would put the power of choice in the hands of the patients and their doctors. This legislation would protect patients' access to potentially life-saving medicine that has cleared phase one of the FDA's approval process.

This bill does not attempt to strip away the precautions and structure of the FDA to provide safe and effective medications to patients.

Healthcare is extremely personal, and the decision to pursue medical treatment should be at the discretion of the patient and medical professionals, not in the hands of Washington bureaucrats. That said, this legislation does not force the hand of pharmaceutical drug companies either -- it merely cuts out an arbitrary barrier for those seeking treatment who have exhausted all other possibilities.

This is a humanitarian issue where people's lives are currently left in the hands of Washington bureaucrats. From a federalism perspective, the states are the laboratories of democracy. With overwhelming support and passage of right to try in 37 states, this bill would provide alternative pathways for patients to access medicine without dancing around the red tape that is federal bureaucracy.

The Right to Try Act, H.R. 878, the companion legislation to the Trickett Wendler Right to Try Act, has been introduced by Rep. Andy Biggs, R-Ariz., and is languishing in the House Energy and Commerce Committee. Similarly, this legislation would require a medical doctor's consent that the patient has exhausted all other possibilities and is in accordance with state law where right to try has already been passed. The bill would also require that the medicine in question not be legalized and open to the public until successfully passing all stages of the clinical approval process carried out by the FDA.

The human cost of not passing right to try is innumerable and it would be a travesty for the House not to vote to protect a patient's freedom of treatment choice. With Republican control of both chambers and the executive branch this would be a win for healthcare freedom. President Trump, along with Vice President Pence, have made it a national priority to pass right to try -- while he was governor of Indiana, Pence signed right to try into law.

Advocates like the McLinn family have paved the way for this legislation by staying vocally active on the issue and sharing their story. Thankfully, there is a national movement to free terminally-ill patients of bureaucratic restraints.

Christina Herrin is a contributor to the Washington Examiner's Beltway Confidential blog. She is the legislative outreach manager for FreedomWorks.

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Lives hang in the balance while the FDA bureaucracy churns - Washington Examiner