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# Continue Strong Compliance, Quality Programs: Attorneys
- URL: https://www.fdaweb.com/continue-strong-compliance-quality-programs-attorneys/
- Published: 2025-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:51:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5158533

Three Ropes & Gray attorneys write in their [2024 FDA Enforcement Review](https://www.ropesgray.com/en/insights/alerts/2025/01/2024-fda-enforcement-review-quality-and-transparency-remain-critical-concerns?ref=fdaweb.com) that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective and preventive action to address identified risks.” The attorneys note that protecting the public health by deterring and punishing conduct that compromises the safety and quality of medical products and foods is typically a priority in every administration.

The report covers major 2024 enforcement actions by FDA and the Justice Department for opioid enforcement, medical device quality and transparency, stem cell treatments, and unlawful distribution of animal drugs.

It also discusses developments in administrative and constitutional law and three important court decisions involving legal theories that FDA and the Justice Department have relied on for years. It says that several high-profile attacks on FDA regulatory authority are ongoing and last year’s legal developments “demonstrate increased skepticism of agency interpretations of statutory and regulatory authorities that may have future enforcement implications, both in terms of which cases are pursued and where they are brought.”

Looking to 2025, the attorneys write that it is impossible to predict with any certainty the impact of the new administration on enforcement against FDA-regulated companies and the extent to which the government may retrench or pursue new avenues for enforcement in the aftermath of recent administrative law decisions. “However,” they add, “product safety concerns have historically driven much FDA-related enforcement, regardless of an administration’s political leanings. Companies that fail to appropriately address product risks with the potential to cause significant patient harm are likely to remain high-priority enforcement targets. Executives at life sciences companies should maintain an appropriate ‘tone at the top,’ emphasizing their personal commitment and the company’s commitment to compliance, quality, and transparency.”