H.R. 7071 – Accelerating Access to Critical Therapies for ALS Act

Summary:

This bill establishes a grant program, as well as a new center within the Food and Drug Administration (FDA), to facilitate access to investigational therapies for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig’s disease, a progressive and fatal disease).

Specifically, the Department of Health and Human Services (HHS) must award grants for the provision of investigational drugs for ALS and other rapidly progressing neurodegenerative diseases through an expanded access (i.e., compassionate use) program. HHS may award these grants to (1) a small business that is the sponsor of an investigational new drug application, or (2) a participating clinical trial site for such a sponsor.

Additionally, HHS must establish within the FDA a Center of Excellence for Neurodegenerative Diseases. The center shall have duties and authorities similar to those of the FDA’s Oncology Center of Excellence, which helps expedite the development of medical products and assists providers in requesting access to investigational drugs. (Cosponsors)

ANGIE CRAIG’S POSITION: Representative Craig co-sponsored the bill on 08/22/20.

STATUS: Introduced 6/01/20 by Rep. Fortenberry, Jeff [R-NE-1]

INFORMATION RELATED TO THE BILL:

  • Congressman Jeff Fortenberry (NE-01) offered the following statement after introducing the Accelerating Access to Critical Therapies for ALS Act in the U.S. House of Representatives. The bill expands ALS patient access to promising treatments beyond the clinical trial and establishes a Center of Excellence for Neurodegenerative Diseases at the FDA to accelerate development and approval of such therapies.

    “Just over one month ago, my wife’s brother died from ALS. He was 37, with a wife and four small children. His suffering, the heartache, the toll on his family is repeated over and over in families throughout America,” Fortenberry said.

    “New treatments for ALS are bringing hope. But drug trials can drag on for a decade or longer. Victims of fast-moving ALS do not have that kind of time. Our regulatory process does not match the urgency of the disease. It’s killing hope. Let’s do something about it,” Fortenberry added.

    Rick Laswell of Lincoln added: “Having ALS has led me to want to do whatever I can to help others with the same awful disease. Congressman Fortenberry’s bill ACT for ALS gives me hope that people in Washington are listening to our cry for help.”

    (Source: Rep. Jeff Fortenberry Press Release, 06/16/20)

ADDITIONAL DETAIL:

Link to the text of the bill.

Link to bill information (support and opposition) on Countable.

Link to bill information on GovTrack.

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