The regulatory environment for packagers of pharmaceuticals, biologics, and medical devices appears challenging, yet manageable. That’s a “big-picture” perspective based on respondents to a late-September Healthcare Packaging survey question that asked, “Describe your take on the current ‘revitalized’ FDA and regulatory environment as it relates to your packaging operations?”
A large share of this question’s respondents came from the medical device arena, where one person believed the “FDA appears to have an adversarial stance again.”
Taking a more promising position was another medical device respondent who said, “Love it—much more cooperation that allows us to be prepared with the information wanted.” The respondent did add that the company encountered, “A bit more problems with filings required for items that used to be end-of-year changes.”
Not surprisingly, perhaps, a packaging vendor responded, “Increased regulatory scrutiny and activity actually drives business for a consulting firm like ours.”
A bit of a political spin came from a personal care maker respondent who wrote, “We expect government regulation to stay the same or increase a little. The government does not want to be perceived as slowing down growth through increased ‘red tape.’”
Several respondents offered more specific details pertaining to the impact of FDA and regulatory matters. “My expectation is that the FDA and regulatory environment will focus on the validation aspect of the packaging process, which will encourage many manufacturers to step up and improve their quality systems,” said a medical device respondent.
“This is requiring us to take on more Quality Assurance personnel to meet all customer’s level of requirements,” said another medical device professional.
A pharmaceutical respondent noted, “They are clamping down and putting a significant emphasis on packaging. We have spent quite a lot of effort in the last year ensuring that our processes and procedures are sound and defendable.”
As is often the case, the potential for increased regulations caused concern. “At this point [there’s] no direct impact, but they are beginning to take more interest in the packaging and labeling,” said a medical device person. Another medical device respondent said it “could add additional regulatory work to an already overburdened system.”
One more medical device maker pointed to the bottom line as it related to potential costs to create unique package identification. “Changes like [this], while necessary, will require significant resources to implement.”