Drugs

Bill to Speed Rare Disease Trials

Bipartisan legislation intended to accelerate the development of rare disease treatments by making clinical trials faster, cheaper, and more accessible to patients was to be introduced in the House on 10/22 by Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA). CNBC Cures reports that the Faster Clinical Trials Act is intended to make it easier for patients to participate in clinical trials and to reduce the time it takes to start such trials. It would also encourage drug companies to use computer simulations in early-stage drug development and would address some of the common reasons why FDA suspends clinical trials to avoid delays.

Auchincloss told the network that the bill aims to create a network of “reusable” clinical trial sites so “you’re not recreating the wheel every time you’re trying to do a new drug. You have a platform, and now you’re just trying one thing after another.”

Griffith said the bill is trying to bring clinical trials to patients, rather than the current model in which patients must travel to a clinical trial site.

The legislation would create an FDA Center for Clinical Trial Innovation to coordinate networks of clinical trial sites. It also gives specific instructions to the agency’s Rare Disease Innovation Hub, including giving it the authority to consult with drug companies about their concerns and provide help to agency review teams.

The Duke-Margolis Institute for Health Policy at Duke University helped to draft the bill. Griffith said he does not expect it to come up for a vote until next year. Auchincloss’ office told CNBC they are working with a bipartisan group of senators to introduce companion legislation.

Auchincloss said he expects the House will approve the bill because it appeals to a wide range of people, from drugmakers and patient groups who want faster and cheaper clinical trials to members of the MAHA (Make America Healthy Again) movement who want greater access to experimental treatments. “There’s something in here for everyone to like,” he said.

FDA Releases 27-Page Mylan FDA-483

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Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

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SARMS Pharm Sentenced in Unapproved Drug Case

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FDA Releases 27-Page Mylan FDA-483

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

Support For and Ideas to Change GDUFA 4

SARMS Pharm Sentenced in Unapproved Drug Case