Ranica Arrowsmith, Associate Editor05.21.14
When Nancy Singer left her job as special counsel for the Advanced Medical Device Association, she founded Compliance-Alliance to help medical device and drug professionals establish a culture of compliance where they worked. That year, she conducted a survey of regulatory and quality professionals in these industries to determine how their companies felt about regulatory compliance, and the role of the RA/QA (regulatory affairs and quality assurance) professional. The results showed that many companies did place a high value on compliance and viewed the RA/QA function as a key department that interpreted the government’s regulatory requirements and educated various departments on their responsibilities. However, about 25 percent of respondents said that their CEO did not emphasize regulatory compliance and had a negative view of the RA/QA professional.
Ten years later, Compliance-Alliance followed up with the same survey to see if the environment in medical device and drug companies had changed. Singer predicted that in the past decade, companies that responded in 2004 would have matured and evolved. New companies, she believed, would respond to the government initiating high visibility regulatory actions to ostensibly force CEOs to understand the need to make regulatory compliance a priority.
“I was surprised at the results,” Singer told Medical Product Outsourcing. “Things remain pretty much the same. Seventy five percent of the companies put a high value on regulatory compliance and the role of the RA/QA professional, and 25 percent did not view the RA/QA professional in a positive light.”
When asked why things failed to improve for the sizable minority, Singer said, “A lot of new companies come into the field every year. These companies do not understand the vital role that RA/QA officials play and how creating a culture of compliance can improve customer satisfaction and employee morale.”
Daniela Drago, Ph.D., assistant professor and program director of regulatory affairs for George Washington’s School of Medicine and Health Sciences, has worked at large and small device and drug companies during her pre-academic career in industry. She believes that new small and mid-size companies may lack the necessary knowledge and resources.
“Often they do not perceive the harm that can be done to a company,” Drago told MPO. “They underestimate the costs and resources associated with repairing a damaged reputation. It is surprising that—in spite of all the incidents that occurred in the past ten years, which attracted the media’s attention, and were due to lack of compliance—things failed to improve. We should look at whether a correlation exists between companies that are guarding their image through compliance, and the ones that are successful in bringing new products to market and ensuring financial sustainability.”
More than half of the survey respondents said that they followed their quality policy only “most of the time.” Quality policy refers to the company’s vision surrounding quality assurance, which is different than quality regulations as set forth by the U.S. Food and Drug Administration. But policies are put in place in order to meet compliance requirements as well as maintain a certain standard of quality expected by a company’s customers. Why would a company set a policy, and not follow it?
“The Quality System Regulation (21 CFR 820.3) defines the Quality Policy for a company as the ‘overall intentions and directions of an organization with respect to quality,’” Singer explained. “Quality policies are written as intentions or aspirations and state that the company will always comply with all laws and regulation and will meet or exceed customer expectations. The world is not a perfect place. People are human, and mistakes occur. Companies can’t always be 100 percent compliant, and they can’t always exceed their customer’s expectations.”
“Developing new drugs and medical devices became increasingly challenging in the last few decades,” Drago said. “The increasing demands of regulatory agencies worldwide contributed to making research and development for pharmaceutical and medical device companies costlier and more difficult. Some companies, to increase competitiveness, may try to ‘cut corners’ about compliance. I believe that a number of companies—rather than following quality policy ‘most of the time’—could benefit from a periodical reevaluation of the effectiveness of their systems. Are individual regulatory compliance programs mitigating the ‘right risks’? Are resources allocated efficiently? Some companies may find themselves spending resources on issues that are no longer important, while not addressing others that could have more serious implications if ignored. Risk assessment is a powerful tool and, at times, it is overlooked. Compliance without risk assessment is a job half done.”
The survey also highlighted the attitude some medical device and drug workers have that RA/QA personnel being a “necessary evil.” According to Drago, this attitude stems from several factors. First, some RA/QA professionals lack the skills to be effective business partners, and need to be able to provide strategic rather than just technical guidance. Second, some companies fail to educate non-quality professionals on the benefits that RA/QA personnel provide. Without this knowledge, Singer said, quality personnel are often seen as the gatekeeper that stands between the development process and the success of a product on the market. The RA/QA professional is seen as the person who always says “no.” RA/QA professionals would do well to be able to offer creative solutions to achieve compliance, rather than simply approving or rejecting efforts.
Both Singer and Drago are working towards improving communications in the medical device and drug space among regulatory/quality professionals, management, and other players such as R&D personnel. Compliance-Alliance offers a course titled “Talking to Top Management: What to Say and How to Say it,” designed to teach employees how to talk in a language that their management will understand. Over at George Washington University, Drago is also working with Compliance-Alliance to teach RA/QA professionals to analyze incidents where there could be a potential regulatory issue. Students in Drago’s program are tasked with developing clear and concise documents to inform management of key issues. The students also learn best practices for providing recommendations and suggesting an appropriate course of action. This is an example of how courses at GW aim to increase the student’s problem-solving skills to address the challenges of development and commercialization of medical products. More information about the master's degree program in regulatory affairs at GW is available here.
To view the entire survey, follow this link.
Ten years later, Compliance-Alliance followed up with the same survey to see if the environment in medical device and drug companies had changed. Singer predicted that in the past decade, companies that responded in 2004 would have matured and evolved. New companies, she believed, would respond to the government initiating high visibility regulatory actions to ostensibly force CEOs to understand the need to make regulatory compliance a priority.
“I was surprised at the results,” Singer told Medical Product Outsourcing. “Things remain pretty much the same. Seventy five percent of the companies put a high value on regulatory compliance and the role of the RA/QA professional, and 25 percent did not view the RA/QA professional in a positive light.”
When asked why things failed to improve for the sizable minority, Singer said, “A lot of new companies come into the field every year. These companies do not understand the vital role that RA/QA officials play and how creating a culture of compliance can improve customer satisfaction and employee morale.”
Daniela Drago, Ph.D., assistant professor and program director of regulatory affairs for George Washington’s School of Medicine and Health Sciences, has worked at large and small device and drug companies during her pre-academic career in industry. She believes that new small and mid-size companies may lack the necessary knowledge and resources.
“Often they do not perceive the harm that can be done to a company,” Drago told MPO. “They underestimate the costs and resources associated with repairing a damaged reputation. It is surprising that—in spite of all the incidents that occurred in the past ten years, which attracted the media’s attention, and were due to lack of compliance—things failed to improve. We should look at whether a correlation exists between companies that are guarding their image through compliance, and the ones that are successful in bringing new products to market and ensuring financial sustainability.”
More than half of the survey respondents said that they followed their quality policy only “most of the time.” Quality policy refers to the company’s vision surrounding quality assurance, which is different than quality regulations as set forth by the U.S. Food and Drug Administration. But policies are put in place in order to meet compliance requirements as well as maintain a certain standard of quality expected by a company’s customers. Why would a company set a policy, and not follow it?
“The Quality System Regulation (21 CFR 820.3) defines the Quality Policy for a company as the ‘overall intentions and directions of an organization with respect to quality,’” Singer explained. “Quality policies are written as intentions or aspirations and state that the company will always comply with all laws and regulation and will meet or exceed customer expectations. The world is not a perfect place. People are human, and mistakes occur. Companies can’t always be 100 percent compliant, and they can’t always exceed their customer’s expectations.”
“Developing new drugs and medical devices became increasingly challenging in the last few decades,” Drago said. “The increasing demands of regulatory agencies worldwide contributed to making research and development for pharmaceutical and medical device companies costlier and more difficult. Some companies, to increase competitiveness, may try to ‘cut corners’ about compliance. I believe that a number of companies—rather than following quality policy ‘most of the time’—could benefit from a periodical reevaluation of the effectiveness of their systems. Are individual regulatory compliance programs mitigating the ‘right risks’? Are resources allocated efficiently? Some companies may find themselves spending resources on issues that are no longer important, while not addressing others that could have more serious implications if ignored. Risk assessment is a powerful tool and, at times, it is overlooked. Compliance without risk assessment is a job half done.”
The survey also highlighted the attitude some medical device and drug workers have that RA/QA personnel being a “necessary evil.” According to Drago, this attitude stems from several factors. First, some RA/QA professionals lack the skills to be effective business partners, and need to be able to provide strategic rather than just technical guidance. Second, some companies fail to educate non-quality professionals on the benefits that RA/QA personnel provide. Without this knowledge, Singer said, quality personnel are often seen as the gatekeeper that stands between the development process and the success of a product on the market. The RA/QA professional is seen as the person who always says “no.” RA/QA professionals would do well to be able to offer creative solutions to achieve compliance, rather than simply approving or rejecting efforts.
Both Singer and Drago are working towards improving communications in the medical device and drug space among regulatory/quality professionals, management, and other players such as R&D personnel. Compliance-Alliance offers a course titled “Talking to Top Management: What to Say and How to Say it,” designed to teach employees how to talk in a language that their management will understand. Over at George Washington University, Drago is also working with Compliance-Alliance to teach RA/QA professionals to analyze incidents where there could be a potential regulatory issue. Students in Drago’s program are tasked with developing clear and concise documents to inform management of key issues. The students also learn best practices for providing recommendations and suggesting an appropriate course of action. This is an example of how courses at GW aim to increase the student’s problem-solving skills to address the challenges of development and commercialization of medical products. More information about the master's degree program in regulatory affairs at GW is available here.
To view the entire survey, follow this link.
