Insider Solutions Rule #1: Be in Compliance

At the September 2010 recent PDA/FDA Joint Regulatory Conference, Howard Sklamberg, director of the US Food and Drug Administration's Office of Enforcement, discussed the agency's current enforcement strategy. The strategy is codified in a position paper dated July 15, 2010 (available on the FDA website at www.fda.gov/downloads/ICECI/EnforcementActions/UCM225183.pdf) and signed by representatives from all primary FDA centers and offices including the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

Susan J. Schniepp

The document states, "The Food and Drug Administration (FDA) is articulating its enforcement strategy in order to ensure strategic alignment with in the Agency and express why enforcement is critical to protecting public health." The paper clearly defines FDA's areas of responsibility and the scope of their jurisdiction.

One of the most important concepts presented in the paper concerns industry's seeming lack of ability to self-govern their operations to be in compliance with the laws that FDA oversees and enforces. In language leaving little room for interpretation, the document points out that, "Without effective FDA regulatory oversight and enforcement, some regulated entities will disregard even the clearest sregulations or will not be adequately vigilant to ensure compliance with the law, potentially harming the public." The paper goes on to say, "If, during an inspection, investigation and/or through laboratory analysis, a significant violation is identified, FDA will determine as quickly as possible what further agency action might be necessary." In addition, "FDA will use any and all available enforcement tools, as appropriate, based on the facts of the case and the nature and seriousness of the violation."

So what should industry glean from these statements? In this new era of enforcement, it is far better to be proactive than reactive. Companies should routinely monitor the FDA website for 483 and Warning Letter postings. The information contained in these documents offers valuable insight into the issues the agency considers important. Companies should use these observations to assess their own practices and to identify any potential compliance gaps.

If a gap is identified, the company should make the necessary change to remediate the issue and bring the system, process, or procedure into current compliance status. Drug manufacturers also should review their audit programs to ensure they are robust. Reviewing and evaluating one's suppliers—and making sure they can articulate the source and quality of the materials they provide—is another key element for proving to FDA that the firm is in control of its quality systems. In addition, if it is not already done, companies should consider implementing annual good manufacturing practice (GMP) training for all employees.

Another important consideration to ensure current GMP compliance is to make sure the company, and its suppliers, is prepared to host a regulatory inspection. The concept of being "audit ready" has been around for years. Today, companies must challenge themselves to always be ready to host a timely and meaningful audit.

Problems noted during inspections should be dealt with quickly and effectively. When faced with noncompliance issues, a firm should take care and time to properly outline its remediation plan.

The steps to achieve compliance should be clear and specific, and a timeframe for completing each step should be included in the plan. In the event that remediation steps are delayed, the reason for the delay should be documented and a new completion date should be assigned. In such an instance, it would be wise for the company to communicate the reason for the delay to FDA and obtain the agency's agreement to the revised plan.

Overall, drug manufacturers need to step up and take responsibility for their operations. They must ensure conformance to regulations and empower their quality personnel to act responsibly when assessing products and processes in order to meet safety and effectiveness requirements.

By being proactive, firms will be able to maintain an efficient, compliant operation while working effectively with regulatory agencies. In the end, companies will save considerable time and resources by not having to remediate nonconforming and undesirable practices.

Susan J. Schniepp is vice-president of quality assurance at OSO BioPharmaceuticals in Albuquerque, NM, susan.schniepp@osobio.com.