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We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate to drugs and devices. This includes helping with financial, operational, marketing, and investigatory/enforcement issues. Our particular focus is helping clients in Form 483 Observations, Warning Letters, Import Alerts, and other enforcement activities.
For 20+ years our lawyers have advised industry-leading pharmaceutical companies on Good Manufacturing Practices, GMP. These practices are in place to ensure that pharmaceutical companies’ drug products meet quality standards by following regulations on proper design, monitoring, and control of drug manufacturing. The purpose is to avoid contaminations, mix-ups, failures, and errors in the manufacturing of pharmaceuticals.
Open To Interpretation
The challenge of GMP compliance for pharmaceutical companies is that many requirements are general and open to interpretation.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) tasks the FDA with the authority to ensure the safety of pharmaceuticals, among other products. The GMP, set forth by the FDA, outlines regulations requiring manufacturers, processors, and packagers to take steps to avoid contaminations, mix-ups, failures, and errors throughout production stages. The regulations address a variety of issues including sanitation, process, record keeping, complaint handling, and others.
To accommodate the variety of products covered by the FD&C Act, the regulations in the FDA’s GMP are open-ended. This puts the responsibility on the manufacturer to determine how to best interpret the requirements.
Serious and problematic situations can arise for pharmaceutical companies attempting to determine all the rules and regulations they must follow to stay compliant. Your company’s interpretation might not exactly match the interpretation of the FDA inspector. FDA inspectors can be subjective with their review of your company’s compliance, potentially resulting in damaging violations. The consequences of GMP noncompliance range from a damaged reputation, product recalls, and even criminal prosecution.
Counseling from lawyers highly experienced with all elements of the FDA’s GMP can help your company avoid costly violations, and combat damaging accusations of noncompliance. We emphasize that the FDA’s compliance posture may be at odds with prevailing statutes or regulations. This means skillful advocacy can challenge the FDA’s views with the goal of getting FDA back down from its posturing.
FDA Warning Letter
Perceived violations of the GMP commonly result in a warning letter from the FDA. This letter notifies the company of the activities it believes are in violation of the FD&C Act and relevant federal statutes.
Enforcement actions by the FDA follow if the documented violations are not promptly and adequately corrected. This may lead to seizure of property, injunction, and criminal prosecution ranging from fines to jail time.
If your company has just received an FDA warning letter, our lawyers at Upadhye Cwik LLP make sure the FDA takes you seriously. We review the FDA and company correspondence, help push the agency back, and will take legal action such as suing the FDA, if necessary.
Upadhye Cwik LLP’s FDA GMP Compliance Practice
We work with clients on responses to Form 483 Observations, Warning Letters, and Import Alerts. This is especially the case when data integrity issues are raised. While not initially evident, GMP compliance status can affect the 180-Day exclusivity, the ability to market the drug timely, prepare for at-risk launches, or capitalize on a contractual settlement launch date. We work with traditional GMP consultants to ensure that remediation efforts are going well, effectively, and cost-efficient. We provide on-site support to clients during FDA inspections in an effort to ensure that FDA inspections and Observations are being correctly handled.
We offer a robust counseling and compliance practice where we advise clients on matters relating to drug approval, drug marketing, supply chain management, and marketing and data exclusivity issues.
Reach out to the lawyers at Upadhye Cwik LLP to ensure your product the smoothest possible approval by the FDA, and to defend your company against any alleged violations of the GMP.
Shashank Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies, he is known for spearheading innovative business and legal strategies to protect existing drug or device patents – or challenge those of a competitor.