Walker Encourages FDA to Expand Patient Access to Potentially Lifesaving Drugs
WASHINGTON, D.C.- U.S. Representative Mark Walker (R-N.C.) recently led a letter to Dr. Norman E. Sharpless, the acting Commissioner of the U.S. Food and Drug Administration (FDA), encouraging the FDA to expand the Parallel Track and improve patient access to potentially lifesaving medications that have been deemed safe, but not fully approved by the agency.
The letter is signed by U.S. Representatives Mo Brooks (R-Ala.), Ted Budd (R-N.C.), Glenn Grothman (R-Wis.), Jim Jordan (R-Ohio), Steve King (R-Iowa), Thomas Massie (R-Ky.), Mark Meadows (R-N.C.), Ralph Norman (R-S.C.), David Schweikert (R-Ariz.), and Ted Yoho (R-Fla.)
As the letter explains, "despite FDA’s efforts, it still takes on average 10 to 12 years and as much as $2.9 billion to bring a new treatment from lab to patients. This is much too long for many patients with critical illnesses who do not have time to waste. One innovative solution that the FDA has at its disposal is to expand the already existing Parallel Track to other critical diseases."
Created in 1992, the Parallel Track allowed individuals to access a breakthrough drug to treat HIV/AIDS years ahead of the drug’s final FDA approval, while the drug was still in Phase II and III clinical trials. Thousands of suffers had their lives saved because of this quicker access.
"Today, millions of Americans are similarly afflicted by or dying from Alzheimer's Disease, cancer, amyotrophic lateral sclerosis (ALS), and many other debilitating diseases," the letter reads. "However, the drug approval process remains outdated and is not compatible with the innovative nature of medicine in America today. Similar to the HIV/AIDS crisis, promising, potentially life-saving drugs for these diseases are mired in Phases II and III of the drug-certification process. Although often demonstrating amazing results for the few Americans allowed to participate in clinical trials, these much-needed drugs and therapies remain years and billions of dollars of investment away from FDA certification and full access by patients."
"In order to bring these drugs and therapies more quickly and at a lower cost to Americans, we strongly urge the FDA to expand the Parallel Track to target other devastating diseases," it concludes.
You can read the full text of the letter here.
The Parallel Track expansion would build on the successful efforts of the 115th Congress in passing the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, legislation that amended the Federal Food, Drug, and Cosmetic Act to exempt the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs.