New FDA Commissioner Emphasizes Urgency of Compliance
The Obama administration's new FDA Commissioner, Margaret Hamburg, M.D., set the tone for a new era of FDA enforcement initiatives in her first speech to the FDLI this past Thursday (see full transcript). The message to FDA regulated manufacturers was very clear: if compliance to FDA policies is not met, companies can expect swift and costly consequences. With a new administration at the helm, and in Hamburg's words, "Significant Funding Increases," the FDA has given manufacturers fair warning that a streamlined enforcement structure with little room for error can be expected.
This newly shifted paradigm in FDA enforcement action is based upon four key elements as identified by Dr. Hamburg:
- Vigilance including regular inspections and swift follow-up
- Strategic enforcement with meaningful penalties that send a strong message
- Quick response times
- Visibility both to the industry and consumers
Dr. Hamburg's emphasis on these four elements stems from a steep decline in FDA's enforcement activities over recent years as well as unreasonable delays in resolution of violations. These problems cause an erosion in consumer confidence in the public health system as well as an attitude by manufacturers that the opportunity exists to fly under the FDA's radar.
In order to resolve these issues, Dr. Hamburg has outlined 6 initial steps that will guide the FDA's enforcement processes starting September 1st:
| 1. | Designation of post-inspection deadlines: firms found out of compliance now face a response deadline of no more than 15 days before the issuance of a formal warning letter or enforcement action |
| 2. | Expedited Warning Letter issuance limiting review of Warning Letters to only significant legal issues |
| 3. | Closer integration and cooperation with regulatory partners at local, state, federal, and international levels |
| 4. | Better prioritization of post enforcement follow-up involving prompt assessment of remedial activities |
| 5. | Aggressive action will be taken more swiftly, and sometimes in the absence of a formal warning letter if the situation severity warrants and multiple warning letters are less likely to be issued in favor of swifter escalation of issues if the FDA is not pleased with a company's corrective actions |
| 6. | Incorporation of a formal Warning Letter 'Close-Out' process that the FDA's new commissioner hopes industry associates will place at a high priority |
The core of the commissioner's message was driven by a concern for public health, transparency, and accountability for manufacturers. Her expecations on FDA regulated manufacturers are high as she states, "I have been impressed by the commitment to compliance that many companies have made - both in terms of their corporate culture and their investment in compliance systems. Our goal is for all companies to make and implement such a commitment in order to prevent harm to the American people."
There is now a greater sense of urgency and emphasis placed on FDA compliance, and manufacturers need to take notice. The consequences of non-compliance will undoubtedly be dire if swift and effective corrective actions are not implemented. With the new commissioner's initiatives in mind, it is imperative that organizations be proactive in constructing quality systems that are efficient, effective, and well-equipped to withstand tightened regulatory scrutiny. The time is now to make compliance a priority for the continuance of both industry and public health.
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