This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.
This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes. Specifically, the rule addresses how frequently the FDA inspects some facilities, and the listed duties of the inspector.
In the past, the FDA required biennial inspections of drug and biological manufacturing facilities. However, with the introduction of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, the biennial inspection requirement was replaced with a requirement for the FDA to inspect manufacturing plants on a risk-based schedule.
The direct final rule aligns with the FDASIA framework, accommodates the risk-based framework, and clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently as appropriate.
“Biologics are at the forefront of some of the most significant medical advances of the 21 century, but many are also complicated to manufacture. The new regulations reflect the FDA's flexibility to prioritize its inspectional resources to higher-risk facilities, such as those that produce vaccines or gene therapies, and those that have complex manufacturing steps and must be more closely monitored due to the potential for more risk,” said said FDA Commissioner, Scott Gottlieb, MD, in a statement.
“While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase. We’ll continue to inspect facilities at the same standards and enforce the laws and regulations on manufacturing that help protect patients,” Gottlieb added.
In addition to clarifying the frequency of inspection of manufacturing plants, the rule also removes outdated “duties of inspector” requirements. The FDA has deemed that it was unnecessary to list these obligations in the document because those duties are duplicated in the Federal Food Drug and Cosmetic Act (FFDCA). The removal of these regulations, however, does not change the inspection requirements, nor does it amend the actual duties of an investigator.
The final rule applies to all licensed biological products. The FDA hopes that this change will clarify its flexibility to prioritize its inspection resources to higher-risk facilities, such as those involved in the manufacturing of products that raise potentially significant safety concerns.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.