Part 1 - A Focus on the U.S and Europe
The world history of consumer regulations and regulatory agencies began, unsurprisingly, with products consumed by mouth—food and medicines. As we look at some global markets and their entry into formal regulation of products, we see the triggering mishaps and mayhem around food, drink, and drugs. The prioritization of packaging, particularly for medicines and medical devices, was slower to come under the regulatory eye. Perhaps best summed up by now-retired packaging director Nicholas Berendt was his lament to drug and device makers that medical packaging “is not a dust cover.” Fortunately, everyone, regulators included, would come to understand the significance of packaging, paving the way for greater protection and safety in global healthcare.
UNITED STATES
Inciting Incident
In the U.S., the first major regulatory effort occurred in response to a 1901 public health scare. Diphtheria was a prevalent infection in many places, including the United States. The illness was being successfully treated with a serum derived from equine blood. Unfortunately, a contaminated batch of the antitoxin killed 13 children, and a similar incident soon followed in another state.
Regulatory Response
Congress commenced discussions on what controls could be put in place to monitor the safety and purity of biologic medicines such as antitoxins, vaccines and so on. The result was the 1902 Biologics Control Act. Housed under a newly created USDA Bureau of Chemistry, staffed by one scientist, the Act required annual licensing inspections for facilities producing or selling these products.
Regulatory Evolution
Enforcement of the Act was assigned to the Hygienic Laboratory of US Public Health and Marine Hospital Service. The Hygienic Laboratory was a precursor to the NIH. Over the next 30 years, the Bureau of Chemistry would morph through multiple identities until 1979, when it became the U.S. Food and Drug Administration and embarked as the governing regulatory body that it remains today, growing from 1 to 18,000+ employees.
What About Packaging?
It is interesting that the first packaging concern addressed by regulators was labeling. The 1966 Fair Packaging and Labeling Act set standards to require fact-based information. 1970 saw patient package inserts begin. While legitimate, given myriad unsubstantiated claims that too often had resulted in death, packaging as a means of protecting the sterility of contents was not yet on the radar. That conversation would begin in Europe, around medical device manufacturing (see European Union, below).
The FDA’s publication of ISO 11607-1 and -2:2006 ushered in the new era of critical attention to the packaging of medicines and medical devices. The latest version: ISO 11607-1 and -2:2019 remains active even as the next review is set to begin.
BRITAIN/UNITED KINGDOM
Inciting Incident
The British had proven themselves to be ahead of the curve, having taken the reins with food regulation decades before. Unlike a health scare, however, Britain’s impetus for establishing food regulations was ascribed to “national disquiet” over food and drink adulteration, namely bread and beer, in the 1850s. As brewers and bakers sought to increase both product supply and profitability by “diluting” the key ingredients with substitutes, those substitutes were apparently quickly detected by consumers who protested until the government stepped in.
Regulatory Response
Formal inquiries resulted in Parliament’s 1860 Adulteration of Food and Drink Act. The Act would be revamped and expanded to include pharmaceuticals in the 1875 Sale of Food and Drugs Act.
First Regulatory Agency
A read of historic records in The Food Drug Cosmetic Law Journal, reveals that parliamentary ministers acted as regulators charged with enforcing the law. Their role was qualified with language noting that the Act’s “broad principles make for difficulties in enforcement” and referred to availability of “many precedents” to inform both “enforcers and enforced” to encourage voluntary cooperation. The 1875 Sale of Food and Drugs Act remains the DNA of Britain’s modern food and drug law, apart from transferring all drug manufacturing controls to the Medicines Act of 1968.
Current Regulatory Agency
Today, pharmaceuticals and medical device standards are governed by the Medicines and Healthcare Products Regulatory Agency (MHRA). Brexit has challenged the clarity of governance. On March 16, 2023, the UK allocated £10m to help expedite drug and medical device approvals based on foreign trusted regulators, such as the FDA. On April 27, 2023, the MRHA announced that more time is needed to fully establish regulatory criteria for approval of medical devices and packaging. This is a developing timeline.
What About Packaging?
First, a note about EU MDR packaging requirements that also affected the UK prior to Brexit. Packaging remains defined as an “accessory” to medical devices. Labeling requirements are detailed in the EU MDR. With Brexit, the UK points to ISO 11607, while also emphasizing sustainability. Currently, four notified bodies have been certified by the UK to confirm compliance for drug and device manufacturers.
EUROPEAN UNION
Inciting Incident
Due to its comparably short history, the European Union did not experience an “inciting incident” per se, in its regulatory journey. Still, the alliance has been a key contributor to the advancement of healthcare manufacturing and packaging practices.
Regulatory Response
While the United States FDA publication of ISO 11607-1 and -2:2006 galvanized packaging standards around medical devices, it was the EU’s 1993 Medical Device Directives that zeroed in on the “accessory” that was packaging, its role and requirements was the frontrunner of global harmonization for medical device manufacturing, first among member countries, and then beyond.
The publication of the EU MDR 2017 was an achievement of collaboration and expertise that transformed the medical industry climate for member countries and beyond. Global harmonization initiatives were also in full swing and continue today. Transformative conversations with regulatory colleagues and bodies around the world continue to advance safe practices and quality healthcare products.
What About Packaging?
Classified as a medical device “Accessory” under the EU MDR, medical packaging is regulated in alignment with the U.S. FDA’s ISO 11607-1 and -2 standards for terminally packaged medical devices--global harmonization at work!
NOT A DESTINATION
The regulatory road is long and storied. It is at times overwhelming, such as facing new health concerns, contaminations, or missteps. It is at times thrilling, when conquering a threat to human health, bridging a treatment gap, or delivering new ways for people to access care. When manufacturers, packaging professionals and regulators work together for good, then the road is sure to bring safe and pleasant travels for the future.
