FDA publishes "The Enforcement Story" Report

Quite recently, the FDA published "The Enforcement Story" Report. This document may not be known to many colleagues in industry as the FDA has been reorganising its website. Due to this reorganisation, even Google links are not correct at the moment.

The Enforcement Story describes FDA's accomplishments and enforcement-related activities in all product areas over which FDA has jurisdiction. The report contains interesting statistics, like the Enforcement Static from CDER (regulating drugs).

The report also contains information on FDA's "Beyond our Borders Initiative", which is of high interest for companies located outside of the US. "The initiative 4 is a multi-pronged approach to promote and verify compliance of imported food, cosmetics, and medical products or their components with FDA requirements. Goals of the "Beyond Our Borders Initiative" include: increased collaboration and presence in foreign countries, increased number of FDA foreign inspections, greater sharing and use of foreign competent authority inspection reports, use of third party certification, and increased capacity building. FDA has in place more than 70 cooperative arrangements with foreign counterparts to facilitate information sharing and collaborations."

Sharing Foreign Inspection Reports

The sharing of Foreign Inspection report with other regulators is part of the above-mentioned initiative: "In addition to memoranda of understanding, cooperative agreements, and other international arrangements, FDA now has over 30 confidentiality arrangements with trusted foreign counterparts, many of which allow the exchange of information that can include the sharing of inspection reports, and redacted of proprietary information. FDA intends to increase the use of these arrangements to share useful inspectional information that can help FDA make more informed judgments in the risk-based prioritization of foreign inspection activities.

Through negotiation of specific bilateral confidentially agreements with other foreign counterpart agencies, with whom FDA has established equivalent standards for the protection of the public health, the FDA intends to explore opportunities to acquire useful inspectional information and coordinate work plans. For example, the EU-U.S. Bilateral Technical Working Group on Medicines Quality and Manufacturing is focusing on utilizing and leveraging resources through the exchange of inspectional planning data and inspectional observational data for plants in the U.S., EU and in other countries inspected by either the EU or the U.S.

Providing for Certification by Third Parties

Another component of the "Beyond Our Borders Initiative" leverages private sector resources. "FDA is pursuing expanded use of third party certification to verify compliance with U.S. safety and manufacturing standards. These third parties can include foreign government agencies and independent entities who have been accredited by FDA or by an accreditation organization recognized by FDA. Such third-party certifications can provide FDA with helpful information about a firm's compliance with FDA requirements. This certification would not supplant FDA inspectional or other regulatory activities, but would complement them. This information will aid FDA in prioritizing and targeting its compliance and inspectional resources toward high-risk situations.

The China MOA, for example, includes a provision for a registration program, and will work toward a system that will enable the Chinese government to certify the status of Chinese firms that manufacture components of finished drug products. To support the Chinese registration program, and efforts to work toward a certification program, agencies from the two countries will conduct training programs to cover topics such as inspection methods and clinical trials; and will discuss each country's development of relevant technical guidance documents, regulations, and laws. In addition, the Agency is developing a pilot program that would reduce the delay for firms that take pro-active measures when they import finished drug products and active pharmaceutical ingredients (API). This is particularly relevant given the large volume of imported API used in domestic drug manufacturing.

Source: FDA Inspections, Compliance, Enforcement, and Criminal Investigations Page



Conference Recommendations

Go back

GMP Conferences by Topics