Health Subcommittee to Review 20 FDA/Health Bills

The House Energy and Commerce Committee Health Subcommittee has announced a 3/17 hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.” The hearing will discuss various draft legislative proposals to revamp FDA’s approval and oversight of medical products, among other issues.

For example, the subcommittee will review Reps. Fred Upton (R-MI) and Donna DeGette’s (D-CO) 173-page bipartisan Cures 2.0 Act to change how the U.S. provides care to patients and to speed the delivery of groundbreaking cures, treatments, and innovations. One of the bill’s key provisions is the creation of an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health that would be charged with finding new cures and treatments to a slate of illnesses that affect millions of U.S. patients, such as cancer, diabetes, ALS, and Alzheimer’s (see earlier story).

Cures 2.0 also includes Title 3, a large section devoted to FDA reforms. These include:

• 301. Report on collaboration and alignment in regulating digital health technologies.
• 302. Grants for novel trial designs and other innovations in drug development.
• 303. FDA cell and gene therapy.
• 304. Increasing use of real world evidence.
• 305. Improving FDA–CMS communication regarding transformative new therapies.
• 306. Establishment of additional Intercenter Institutes at the Food and Drug Administration.
• 307. Accelerating timeline for breakthrough and RMAT designations.
• 308. Guidance regarding development and submission of chemistry, manufacturing, and controls information for expedited approval.
• 309. Post-approval study requirements for accelerated approval.
• 310. Recommendations to decentralize clinical trials.

Under novel trial designs, the legislation would award grants for (1) incorporating complex adaptive and other novel trial designs into clinical protocols and applications; and (2) the collection of patient experience data with respect to drugs and the use of such data and related information in drug development. Grant priority would be given to incorporating digital health technologies and real world evidence in drug development, it says. Additionally, the bill calls for guidance on the use of real world evidence in evaluating the safety and effectiveness of breakthrough devices and drugs.

The measure also calls for a guidance on the development and submission of chemistry, manufacturing, and controls (CMC) information for expedited approval drugs. The guidance should determine how, and by when, CMC information is required to be submitted throughout development and during the pre- and post-approval phases.

And, the bill calls for FDA to convene a meeting about innovative approaches and incentives to adopt decentralized clinical trials. “Decentralized clinical trial” is defined as a clinical trial method that includes the use of telemedicine or digital technologies to allow for the remote collection of clinical trial data from subjects, including in the home or office setting.

Here is the full list of legislation to be reviewed at the hearing:

H.R. 1730, “Speeding Therapy Access Today Act of 2021”

H.R. 2565, “FDA Modernization Act of 2021” 

H.R. 3085, “Equity in Neuroscience and Alzheimer’s Clinical Trials Act of 2021” or the “ENACT Act of 2021”

H.R. 3927, “Manufacturing API, Drugs, and Excipients in America Act” or the “MADE in America Act”

H.R. 4472, “Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021” or the “BENEFIT Act of 2021”

H.R. 4511, “FDA Advancing Collection of Transformative Science Act” or the “FACTS Act”

H.R. 5030, “Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act” or the “DIVERSE Trials Act”

H.R. 5566, “Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2021” or the “FORWARD Act of 2021”

H.R. 5585, “Advanced Research Project Agency–Health Act” or the “ARPA-H Act”

H.R. 6000, “Cures 2.0 Act”

H.R. 6584, “Diverse and Equitable Participation in Clinical Trials Act” or the “DEPICT Act”

H.R. 6888, “Helping Experts Accelerate Rare Treatments Act of 2022”

H.R. 6963, “Accelerated Approval Integrity Act of 2022”

H.R. 6972, “Give Kids a Chance Act”

H.R. 6973, “Enhanced Access to Affordable Medicines Act”

H.R. 6988, “Drug Manufacturing Innovation Act” 

H.R. 6996, the “Accelerating Access for Patients Act”

H.R. 7006, the “Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act” or the “INSPECTIONS Act”

H.R. 7008, the “Pre-Approval Information Exchange Act” 

H.R. 7032, the “Increasing Transparency in Generic Drug Applications Act”

H.R. 7035, the “Biologics Market Transparency Act”