Medical Device Link.

Originally Published MDDI May 2004

NEWSTRENDS

Mannen: The time is long overdue for a metric to measure FDA compliance.

Erik Swain

Reflecting a trend toward regula-tory affairs professionals using benchmarking and metrics to assess FDA compliance, a consulting firm has come up with a quantitative formula for judging and analyzing compliance.

Aventor (Washington, DC) has developed the Electronic Life Sciences Compliance Index, or Elsci, for device, drug, and biologics manufacturers. The firm says it is a first-of-its-kind tool that aggregates data to produce an overall assessment for FDA compliance and enables comparisons between companies.
 
How it works is that Aventor collects specific types of compliance data and facilitates employee interviews and surveys. It then calculates a score based on a complex formula that gives most weight to elements that cause severe noncompliance. The weighting is based on past FDA enforcement actions. A sanitized version of the data for the customer is then put into a database to enable comparisons with other companies. 

Sherry Keramidas, executive director of the Regulatory Affairs Professionals Society (RAPS; Baltimore), said that while she cannot assess the value of Elsci, it appears to be an indicator of several trends.

One trend is that healthcare manufacturers are taking regulatory affairs issues more seriously and thus the analysis of them is getting more sophisticated. Another is that manufacturers are growing more interested in finding objective measures, from quantitative metrics to benchmarking, to assess regulatory compliance.

Figure 1. Example of CAPA audit observations and selected subindustry peer group comparison. This peer group example consists of manufacturers of therapeutic products with annual sales over $1 billion. Manufacturers choose the most appropriate peer group for their company (Click to enlarge).

“The regulatory process is extremely complex, and it’s very difficult for nonregulatory people to understand that,” she said. “Regulatory professionals want some kind of evidence that they are doing a good job. They always want to have some measure of outcomes success and process success.” 

Ted Mannen, Aventor’s managing director, said a quantitative tool is needed because “regulatory and quality assurance personnel…have had to ask management to make investments without a way to gauge whether the investment pays off. The time is long overdue for a standardized, quantitative metric for measuring FDA compliance. We believe Elsci can fill that void.”

Corporate boards are also in need of such tools, as lack of compliance can hurt bottom lines and reduce market valuations, he said. “They need a compliance metric that will help them take corrective actions, satisfy their fiduciary obligations, and reduce the potential for fines,” he said. 

Edward J. Ludwig, chairman, president, and CEO of Franklin Lakes, NJ–based Becton, Dickinson and Co. (BD), said the tool has been useful for assessing compliance and showing where improvement relative to industry peers can be made. “BD uses it as a tool to determine where and how to deploy our resources, as well as to chart our compliance improvements,” he said.

Keramidas noted that acceptance of such tools would underscore the idea that “regulatory affairs is absolutely critical to corporate strategy. We were seen as paper pushers and roadblocks. Now that an increasing number of companies have paid the price for being in violation, more understand that this is an important part of business strategy.

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