UL helps companies meet safety and compliance standards and regulations across the pharma industry.
UL has had a 15- year learning partnership with the U.S. FDA. How extensive is UL’s U.S. footprint?
Our relationship with the FDA remains intact, with our group formally known as UL Engineering now known as UL Performance to Compliance. Our software platform is utilized by both FDA to train their own inspectors and by many types of clients in either pharmaceuticals, foods, dietary supplements or medical devices to ensure that their own internal systems and procedures are accessible at point of use required by pharmaceutical GMP as well as used for the internal training in our own organization.
In addition to the product compliance group, we have a number of laboratories throughout the United States and internationally that work with medical device manufacturers as well as our consumer team primarily working on the retail side, including three of the top five drug chains in the United States. These retail chains utilize UL’s consumer and retail services group to evaluate their supply chain and to test their products particularly; a niche for us is within the generic products or store-branded products that are widespread among major retail chains. Typically, UL’s consumer and retail services group is one of a key service provider or few service providers that evaluate the compliance of the product against regulations, as well as against the retailer or brand quality requirements.
What is the current relationship between quality and approvals, and how do standards in generics compare to branded products?
There is quite a degree of regulation that goes into the application of the product and it is the major brands that invest that time and resources into proving the efficacy and safety of the products. It is very important for consumers to understand that OTC generic drug products meet the same quality and safety standards as those sold directly by a major brand or in a prescription format prior to approval by the FDA to be sold as an OTC drug.
Alongside the safety of the product, we believe that consumers should be able to have trust in a store brand; that their tablets not only contain the same amount of active ingredients as the actual brand, but that they can trust in the quality and consistency of their product in terms of the breakage, safety seals, and so on. These are all areas that UL tests to ensure that retailer’s products meet the appropriate guidelines, standards, efficacy and quality.
The United States has particularly rigorous quality regulations; are there any gaps between regulation and best practice in the life sciences industry?
The FDA will continue to write 483s and observations against drug manufacturers for a variety of reasons. First, which is perhaps most relevant in today’s economy, is a shift in the way facility systems are assessed both by regulators and certifiers. We have seen a dramatic change in the way the FDA is beginning to evaluate manufacturing facilities, moving from an inspection-based audit to a risk-based audit, with regulators beginning to attain training and demonstrating an assessment that encompasses the level of risk.
What are some of the main expected shifts under the new Administration?
The residing challenge will be around the trust of consumers, which eventually reaches the ears of legislators; there are important defined regulations that are in most cases intended to ensure the safety of the consumer. On the other hand, there are other industry-wide initiatives that help to ensure that the trust of the consumer is intact. At UL, we encourage a cross-section between the two: self-governance by the industry, as long as it is transparent and evaluated by independent parties such as UL, plus the use of regulators to ensure that the products are safe before they reach consumers. One aspect that UL focuses on, for example, is the wide spread of counterfeit products. Some research indicated that 10% of medicines sold worldwide are counterfeit. This is an area that is very difficult to capture from a regulatory standpoint. However, UL has a number of programs; because of the well-known use of our enhanced safety and certification badges, we have an ability to help monitor when counterfeit products are sold with a counterfeit UL mark on it. We work closely with Interpol and several other international agencies to help identify where we have seen the UL Mark used as a counterfeit mark on a product that is likely itself a counterfeit.
What are some of the trends and areas of demand driving UL’s business at the moment?
We see a growth among drug store chains and pharmaceutical brands to evaluate the supply chain not only in terms of the quality and the origin of the raw materials that they are purchasing, but also in terms of the ethical sourcing practices that are utilized. This is an area that affects the entire supply chain from raw extracted materials all the way to process ingredients whether they be active or components of a product, it’s about the supply chains ability to meet and uphold ethical standards.
What role does technology play as a driver?
A number of our business segments and units have begun to look at safety practices and the definition of safety to also include security of records relating to patients, consumers, financials, and so on. External studies show that over 3.6 billion data records were compromised worldwide between 2013 and 2015. This covers data breaches in retail, government, healthcare and financial sectors. The cost of this has jumped past approximately $4 million per incident, which does not even account for potential loss of sales and revenue. We have to ensure that as technology changes, there is a level of security that can be trusted.
What are the plans for UL on the pharmaceutical side of the business over the next three to five years?
There are several key areas of focus across all our business segments. We continue to invest time, resources and knowledge around safety science and offer a range of services to assure organizations of the safety of a product, process or workplace attire. Another focus area over the next few years is to bring clarity to the complexity of the rapidly changing landscape of compliance and regulation. We will also continue to focus on transparency management and on the enhancement of sustainability, helping companies with risk, demonstrate responsibility and differentiate their product in a world that needs to become healthier for people and the environment.