“CRN commends FDA Commissioner Scott Gottlieb and the agency for announcing the implementation of its Program Alignment, a major initiative that will help strengthen FDA’s ability to protect public health. CRN has long urged FDA to move to commodity-based inspections so that the agency could become more efficient and effective in overseeing dietary supplement manufacturing operations, and we are hopeful that the Program Alignment will achieve this,” said Steve Mister, CRN’s president and CEO.
In the new structure, inspectors will work along lines of expertise and interest, rather than being assigned by geographical areas. The reorganization has been several years in the making and was reportedly first conceived to help the agency deal with new responsibilities under the Food Safety Modernization Act. Agency inspectors are expected to be able to handle a variety of assignments, and up to now inspections were apportioned by geographical areas. Inspectors working out of the Dallas district office, for example, would handle whatever inspections came up in their district, be they drug facilities, medical device companies or food firms. Gottlieb’s new plan will have inspectors organized through the following six product specific areas:
- pharmaceutical quality
- medical devices
- biologic drugs, which are made from living organisms and include vaccines
- research, including protecting research subjects and assuring data quality.
“Since FDA issued the Good Manufacturing Practices (GMPs) regulations for dietary supplements nearly 10 years ago, both industry and FDA’s inspectors, who have been previously enforcing as product generalists, have been challenged to understand and implement the minutiae of these requirements that are critical to ensuring product safety. We are strongly supportive of the Program Alignment as it will allow FDA inspectors to develop expertise in the manufacturing of a particular class of products, such as dietary supplements, and foster increased collaboration between FDA inspectors and the industry in addressing the challenges of dietary supplement GMPs,”Mister said.
CRN and other industry stakeholders have long advocated for full enforcement of the provisions of the DSHEA. Among these are continued thoughtful enforcement of GMP compliance. While there has been some indications that GMP is slowly improving, the rate of basic failures mentioned in warning letters, such has lack of basic specifications and batch and master manufacturing records, has been disturbingly high. Having inspectors who are thoroughly familiar with a product category such as dietary supplements is expected to enable FDA to move to finer-grained aspects of GMP compliance, such as looking at the scientific validity of a company choosing one testing method over another.
“Overall, FDA’s Program Alignment is a positive step in the agency’s efforts to fully enforce the law, which will ultimately benefit the consumer who deserves the highest quality dietary supplement products,” Mister said.