Enforcement Actions Rising

Recently, expanding global markets and increased volume of products has increased the real and present threat to consumers, as can be seen by recent public health issues;

• lead based paint used by Chinese toy manufacturers,
• deadly excipients in veterinary food products,
• salmonella outbreaks in spinach and peanut products, and
• Heparin contamination.

The American public expressed significant concern with respect to FDA’s ability to identify a problem prior to product distribution. It appeared as though FDA’s most significant role had become monitoring product recalls, after damage had been done.

The organizational model of the FDA is intended to provide proactive protection. Clinical trials, data monitoring, licensing, post market investigations, and contemporary inspection standards are tools intended to verify that products are safe prior to and post approval.

The growth in size and efficiency of the FDA had not kept pace with the size and scope of the marketplace. As a result, efforts to create a model that has the ability to respond faster to any immediate cause of concern have resulted in significant modifications to the enforcement actions and policy of the FDA.

The FDA, with Commissioner Dr. Margaret Hamburg at the forefront, is strategically realigning the expectations of the industry and the American public (see my previous blog for 2010 trends).

Dr. Hamburg, introduced six new enforcement procedures on September 15, 2009. She initiated the new FDA enforcement campaign saying, “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.”

Commissioner Hamburg has been disapproving of FDA’s handling of certain issues in the past. She stated that the FDA had been hindered by “unnecessary and unreasonable” delays and had allowed serious violations to go unaddressed for too long. Commissioner Hamburg is committed both to change and to creating a “strong FDA.” She believes that “effective enforcement” is the first line of defense.

According to Dr. Hamburg, the FDA enforcement campaign will enable FDA to effectively:

• Conduct regular inspections

• Follow up and ensure that problems are resolved

• Focus more on “significant risk and violations”

• Rapidly respond to violations that pose a health risk and/or are flagrant violations

• Use “meaningful penalties to send a strong message”

Commissioner Hamburg anticipates that the six new policies, listed below, will not only ultimately protect consumers, but will also cause companies to take actions from the FDA seriously and reply and/or act in a timely manner.

1. Post-Inspection Reply Deadline and Penalty
If a company receives negative observations (483) after an inspection, FDA will expect a response in no more than 15 days. Failure to respond within 15 days will now be considered grounds to take an advanced enforcement action.

2. Chief Counsel Pre-Review Policy Abandoned – Regional Authority Increased
Issuance of Warning Letters will no longer require review by FDA’s Chief Counsel Office. The Chief Counsel will be involved form this point on in the review of significant legal issues only. The impact of this modification is the granting of authority to regional offices to issue warning letters independently, outside of a central agency review.

3. Integration with Regulatory Partners
Each manufacturer monitored by FDA is also monitored by state and local regulatory authorities, as well as additional federal authorities. The FDA is integrating informally with these agencies in order to share information, optimize resource usage, and develop risk control and enforcement strategies.

4. Increased Post Finding Surveillance
In the past, poor performance on the part of industry was observed, manufactures notified, and often months and years could pass prior to significant investment of FDA resources. The new enforcement policies will prioritize the dedication of agency resources to post violation surveillance.

5. Swift and Aggressive Action Without a Warning Letter
Previously, significant actions such as seizures, federal injunctions, and licensure revocation, were preceded by the issuance of a one or more Warning Letter (see 2). This process was lengthy, and could allow dangerous production practices to proceed for great lengths of time prior to greater involvement of the agency.

The FDA is abandoning the practice of issuing multiple Warning Letters, and it is beginning the practice of bypassing issuance of a Warning Letter all together if the agency finds a significant health concern or flagrant violations.

This policy change, coupled with the change noted in item 2, could reduce the amount of time it takes to place subpar manufactures under a federal injunction by months and years.

6. Clarification of Status: Warning Letter “Close-Out” Process
In the past, companies with long histories of violating regulations may have received over time many observations, fines, and Warning Letters. In some situations, this has lead to a relaxed attitude within the industry with regard to the receipt of a Warning Letter.

In order to make the status of those companies clearer and the current thinking of the FDA more visible, those companies that the FDA feels have remediated their sub-par practices will be issued a formal “Close-Out” letter, formally ending the notice of warning.

The message here is that all companies who have a received a Warning Letter but have not a received a Close-Out Letter are still under increased scrutiny and still considered subpar.

It is imperative that we in the industry remember that the changes are an example of the agency’s adaptation to current threats, and will provide all of our loved ones with greater protection. The most significant step we can all take to contribute to that mission is the visible and strong promotion of quality within our own organizations.

What can we all do to promote quality within our organizations?

• Respect the Regulations – they are not suggestions

• Respect the Regulators – they have taken an oath to protect the health and safety of the American public – the more successful they are, the safer our children and our parents are

• Respect tools that standardize the workflow – follow SOPs and Batch Records; if they require improvement, bring that to attention and improve them

• Encourage active participation in internal site and system audits to identify opportunities for improvement

• Control Change

• Measure the effectives of change

• Critically assess your organizations practices against the intended level of control defined within the regulations, perfect where they can be perfected

• Foster an in depth awareness of the cGMPs among your peers

• Review all of the information on www.FDA.gov and stay current with the dynamic nature of the little c in “cGMP”

• Mentor the junior staff

• If in doubt, call the Quality Unit

And again, as always, remember the fundamentals of the cGMPs…
• Do What You Say, Say What You Do
• Reflect Reality
• Quality Product is Born of a Quality Process *

Corrine R. Knight & Gina Guido-Redden

* © Coda Corp USA 2009. All rights reserved.

– Lisa Baird. (2009) FDA Commissioner Announces Aggressive New Enforcement Policy

FDA Commissioner Announces Aggressive New Enforcement Policy

– Sheppard Mullin. (2009) Hamburg at the Helm: FDA Commissioner Sets New Enforcement Priorities

Hamburg at the Helm: FDA Commissioner Sets New Enforcement Priorities

– Labcompliance News. (2009) FDA Commissioner Announces Six Steps to Improve Enforcement

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