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
http://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
Susan J. Schniepp is vice-president of quality assurance at OSO BioPharmaceuticals in Albuquerque, NM, firstname.lastname@example.org