NY Defense Attorney Addresses Violations of Current Good Manufacturing Practice Regulations
Current Good Manufacturing Practice regulations (CGMPs) establish systems and protocols that drug manufacturers must abide by. These systems are aimed at ensuring drug formulas are adequately and appropriately established; that manufacturing systems are properly designed; and that monitoring occurs to avoid safety risks in drug manufacturing and processing. The goal of CGMPs is to protect the integrity of pharmaceuticals by assuring drugs are sufficiently pure, appropriately identified, and in the correct strengths and dosages. The Food and Drug Administration (FDA) enforces CGMPs.
If a company fails to follow Current Good Manufacturing Practice regulations, the drugs the company produces are considered adulterated, which in this context means the drug was not manufactured under conditions that were in compliance with CGMPs. The FDA may take action, from issuing warnings or encouraging recalls to seizing the drug and pursuing court action to get an injunction to stop production. The Department of Justice and Health and Human Services may also pursue actions against drug companies that commit Good Manufacturing Practices violations.
Bukh Law Firm, PLLC can provide legal representation to companies and individuals accused of wrongdoing in connection with drug manufacturing or processing violations. A New York City defense attorney at our firm can aid clients in devising a comprehensive legal strategy to effectively resolve all criminal and civil actions with the minimum of consequences.
What are Current Good Manufacturing Practices Violations?
Title 21 of the Code of Federal Regulations is entitled “Food and Drugs,” and it sets forth regulations for the Food and Drug Administration, the Office of National Drug Control Policy, and the Drug Enforcement Administration (DEA). Current Good Manufacturing Practices are specifically found in Code of Federal Regulations parts 210 and 211; however, all provisions of Title 21 apply, even those that are not exclusive to drugs, biologics, or medical devices .
CGMPs impose many specific obligations to ensure drugs are safe, but manufacturers have leeway to write their own procedures for how Good Manufacturing Practices are implemented. If drug manufacturers or processors do not develop protocols that meet basic minimum standards, or if they fall short of the latest standards of practice and employ procedures inconsistent with regulatory expectations, the FDA and other federal agencies can take action.
Violations of Current Good Manufacturing Practices Violations
Most GMP violations are negligent, rather than intentional- although some companies do violate Current Good Manufacturing Practices intentionally. Failure to follow standard operating procedures for drug manufacture is an especially common violation, but many lapses can be considered regulatory violations including:
- Failure to follow internal procedures for preparation of master production
- Failure to follow procedures aimed at preventing microbiological contamination
- Failure to monitor employees entering aseptic filling areas
- Inadequate prevention of contamination of areas used for aseptic processing
- Inadequate investigations into batch failures or failure to keep appropriate batch records
- Changing original data in batch reviews or destroying batch records for unexpired drugs
These are just some of many different potential violations. Because there are so many rules associated with drug manufacture and distribution, defendants could be found to have violated multiple regulations if they do not perfectly conform to FDA rules.
Penalties for Violating Current Good Manufacturing Practices
The Department of Justice, Food and Drug Administration, and Department of Health and Human Services are among the federal agencies that impose consequences for failure to follow best practices for drug manufacturing.
Penalties for violating CGMPs can be significant. For example, GlaxoSmithKline paid $3 billion to settle a health care fraud case, entering into a criminal plea agreement with the Department of Justice and admitting to introducing misbranded drugs and failing to report safety data.
Both civil and criminal actions are common in CGMP cases and defendants will need help from a NY defense attorney who can assist with the development of a comprehensive approach to defending against all claims.
How a NY Defense Attorney Can Help
A NY defense attorney can provide aggressive legal representation in civil and criminal cases arising from alleged violations of Current Good Manufacturing Practices. Our firm handles all types of pharmaceutical fraud cases and we represent drug companies, pharma employees, and others in the healthcare industry who have been accused of violating the law. Call Bukh Law Firm, PLLC today to learn more.