House committee advances bills on advanced manufacturing, opioids and more

Regulatory NewsRegulatory News | 21 July 2021 |  By 

Following a brief markup on Wednesday, the House Energy and Commerce Committee advanced 24 bipartisan health- and cybersecurity-related bills to the House for consideration, including bills aimed at advanced and continuous manufacturing for pharmaceuticals, supporting vaccination and addressing the ongoing opioid crisis.

The first bill to be considered during the markup would amend the 21st Century Cures Act to enable the US Food and Drug Administration (FDA) to designate five national centers of excellence in advanced and continuous manufacturing. The bill, known as the National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act, or H.R. 4369, was introduced by Committee Chairman Frank Pallone (D-NJ) and Brett Guthrie (R-KY) and mirrors a similar bill that passed in the House last year. (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more, Regulatory Focus 29 January 2020)

For years, the US Food and Drug Administration (FDA) has nudged industry on adopting advanced and continuous manufacturing processes as a means of increasing quality and supply chain resilience. Legislators and multiple administrations have also championed the technologies as a means of onshoring pharmaceutical manufacturing. (RELATED: FDA touts advanced manufacturing to address COVID shortfalls, Regulatory Focus 4 August 2020)

Pallone, upon introducing the bill, said it reflects “The need to invest and support domestic pharmaceutical manufacturing is critical. Many of the supplies we rely on for pharmaceuticals, whether they be active ingredients, raw material, or glass vials, are produced largely overseas.”

The bill would authorize $100 million to support the centers of excellence and to cover administrative costs at FDA between FY2022-2026. As amended, only 8% of the amount made available each fiscal year may be used to cover federal administrative expenses.

“These centers would work closely with industry and the FDA to facilitate further research and development in advanced and continuous manufacturing technologies, support regulatory guidance and expertise, and develop an advanced manufacturing workforce here in the United States,” Pallone said.

Another bill that made it through markup would increase amount of funding the National Institutes of Health and FDA are able to provide to their supporting foundations, the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration, to between $1.25 million and $5 million annually.

Several of the bills target the ongoing opioid and substance use epidemic, and would authorize the State Opioid Response Grant program, designate methamphetamine as an emerging threat and require federal agencies to develop and disseminate training materials for pharmacists on verifying the identities of patients receiving controlled substances.

Additionally, four of the bills are intended to increase access to vaccines for children, pregnant and postpartum individuals, and nursing facility staff, as well as to raise awareness of human papilloma virus (HPV) vaccines.

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