Regulatory affairs professionals play different, defined roles within the lifecycle of a drug, biologic, or medical device. From conception and development to approval and launch, each stage of the commercialization process requires individuals with specific expertise, in areas ranging from clinical data collection to capturing and reporting adverse events.
With today’s ever-changing laws and regulations, however, there’s a growing demand for well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market.
Developing that understanding requires staying up-to-date on emerging trends within the industry. Dr. Stephen Amato, PhD, MBA, RAC (US/EU), associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, previously shared tips on how to stay competitive in regulatory affairs, including keeping up with current and emerging issues in the field.
According to Dr. Amato, here’s what’s in the works:
Manufacturers are now leveraging social media networks, such as Facebook and Twitter, to advertise their products.
“From a regulatory science standpoint, we haven’t figured out how to regulate those sorts of marketing communications,” Dr. Amato says.
For example, if the U.S. Food and Drug Administration (FDA) approved a product as safe and effective for clinical use for a specific indication for use, the messaging needs to be clear about the actual components or contents of the product deemed “safe and effective for that indication for use.”
“It’s very easy for manufacturers to put out 140-character tweets or Facebook messages that don’t necessarily align well with what their product was approved for,” Dr. Amato says. “This is not necessarily intentional. But the overall question is: How do we modulate what’s actually shown on Facebook and Twitter? And if there’s something that’s not appropriate to be aired, how do we crack down and remove it?”
Manufacturers want to ensure they aren’t falsely advertising their products. But what can companies do if a consumer promotes a product for use outside its approved indications? A question professionals are exploring is: Should the manufacturer be responsible for that content?
Another area Amato sees evolving is reimbursement, particularly how regulatory affairs professionals decide which products are and aren’t reimbursed.
If a biomedical product is used in a clinical setting, the price of the product may or may not be reimbursed by government or private funds, according to Dr. Amato. The decision of whether the device is reimbursed is typically made through the submission of clinical data—the same data used to submit regulatory applications.
Each agency has its own criterion, however, for how it evaluates products. The FDA provides marketing approval based on an evaluation of “safety and efficacy” for a particular indication use, while the Center for Medicare and Medicaid Services (CMS) focuses on “reasonable and necessary” in making reimbursement coverage decisions for biomedical products. So, although the same clinical data may be used by both agencies, the evaluation process could differ substantially.
“There’s a regulatory reimbursement convergence going on within the industry,” Dr. Amato says, “where agencies like the FDA are giving manufacturers guidance on what types of studies they can conduct to receive both reimbursement, as well as regulatory approval, when they launch their products.”
Staying informed on best practices, which are still developing, can help you bring your company’s product to market sooner.
But professionals can’t keep their focus solely on the domestic market. Regulatory frameworks emerging outside the United States are also worth paying attention to.
“In China, medical device regulations are becoming very sophisticated,” Dr. Amato explains. “And in other areas in Eastern Asia, as well as Africa, many biomedical products are not regulated when they’re commercialized, so the setup of regulations is progressing rapidly.”
Consider your company’s own global strategy and how the changes in these markets might impact your mission. Understanding how these international markets work can only make your strategy stronger.
To continue to stay on top of these emerging trends, Amato urges aspiring regulatory affairs professionals to read.
“Read the newspaper,” he says. “Read the Wall Street Journal. Read whatever you can. Visit the FDA website and look at the Federal Register often. Make sure you’re familiar with the Regulatory Affairs Professionals Society website.”
As the regulatory affairs field continues to evolve, you want to make sure your skills are evolving with it.