In the regulatory affairs field, the only constant is change. For current and aspiring regulatory professionals, it’s important to stay abreast of emerging industry trends to keep your skills relevant.
Dr. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, shares three pressing developments on the horizon for several regulated industries.
As medical devices, pharmaceuticals, and biologics become increasingly sophisticated, the cybersecurity and regulatory affairs industries are beginning to merge. Many devices and drug delivery mechanisms that were previously approved by the FDA are now being updated with software and other digital features, allowing them to connect and communicate with multiple systems.
These technological improvements, occurring in devices such as wearables, pacemakers, “smart” insulin pumps, and remotely controlled skin patches for drug delivery, enable greater access to medical information and improved health monitoring. They also introduce new risks. Like all technology, these devices can be hacked.
It’s now critical for the regulatory industry to address these security risks, because it’s not just sensitive personal information at stake. Many of these devices administer drugs and help control critical bodily functions, meaning breaches in security can have potentially fatal consequences. In an effort to ensure the safety and efficacy of these rapidly evolving technologies, the FDA recently formed the Digital Health Group to focus on mobile health, health information technology, wearable devices, telehealth, and telemedicine.
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Dr. Amato believes cybersecurity will also soon become its own specialized area within the field, adding to the already broad range of regulatory career paths. “The intersection of these two fields is driving a growing demand for individuals with backgrounds in computer science, analytics, biomedical engineering, and software development,” he says.
As is common practice in many financial organizations, medical device companies are beginning to hire “ethical” or “white hat” hackers—security professionals assigned to find, exploit, and fix vulnerabilities in systems to prevent security breaches and improve product quality. There will be a growing demand for individuals who possess these cybersecurity skills and regulatory knowledge.
The FDA has distinct regulations for both food and drugs. But what happens when the two categories become one? With mounting evidence on the value of specialized nutritional products in the treatment of disease, this question has now become more than hypothetical.
“Medical food,” also known as Food for Special Medical Purposes (FSMP), is a new regulatory category that sits at the corner of nutrition and medicine. Created specifically to manage disease, these food products align with distinctive dietary requirements of at-risk groups, such as infants, the elderly, cancer patients, people with chronic diseases, trauma victims, and other immunocompromised populations.
Like all other regulated products, these foods are subject to FDA regulatory processes and must undergo well-designed, randomized, controlled clinical trials. Regulations are still evolving, however, regarding the scope of products in this category. It’s still up for debate as to what types of diseases can be clinically managed through a modified diet, and which types of medicinal foods should be allowed to make such health claims.
While some FSMP regulations exist in North America, the European Union, Australia, Japan, and China, there are still many regulatory decisions to be made. As industry professionals continue to explore the best way to classify FSMPs and specialized nutrition products, they must also rule on regulations around composition, registration, packaging, labeling, and promotion.
Related to FSMPs are nutraceuticals. These personalized nutrition supplements are being developed for populations outside of at-risk groups to help with areas such as weight management, healthy aging, and improved cognitive function. As the fields of nutrigenetics and nutrigenomics uncover the genomic impact of dietary choices, consumers will be able to make more personalized dietary choices to optimize their health.
While these emerging nutritional solutions target health issues that are of great consumer interest, they’re not yet formally classified by the FDA from a regulatory perspective. As new, disruptive developments in medical, diagnostic, and nutrition science continue to emerge, these products will continue to shape the regulatory landscape and the practice of modern healthcare.
Market Access and Reimbursement
Striking a balance between time to market and product quality has been, and always will be, a challenge in the regulatory space. Consumers and device manufacturers alike are eager for earlier market access to innovative technologies. Regulatory agencies would also like to improve public health by decreasing the time between product development and patient access, but they have a responsibility to systematically ensure the safety and efficacy of these products—which sometimes means lengthy delays.
A major obstacle to speeding up market access to innovative medical technology is the issue of reimbursement. There are critical advancements being made in gene therapy research, for example, that have the potential to save lives and treat rare diseases, but the cost to produce, regulate, and distribute these drugs is astronomical.
In 2017, there were three new gene therapies approved by the FDA—a “huge advancement for the field,” Amato says. One such advancement involves the genetic engineering of T-cells to cure certain childhood cancers. A single treatment using one of these therapies, however, begins at $475,000. Or take for example the recent groundbreaking cure for a rare congenital disease that causes blindness. With life-changing potential, this treatment requires only a single injection, but comes at a steep price of $850,000.
All stakeholders, including patients, advocacy groups, the Center for Medicaid and Medicare Services, private insurance companies, regulatory agencies, policymakers, and healthcare communities, are asking the same question: “Who’s going to pay for this?”
To get to the answer faster, regulatory bodies are beginning to pilot a process for medical device regulation called parallel review. In this process, manufacturers, insurance companies or health plan sponsors, and regulatory agencies discuss evidentiary needs in tandem, developing clinical studies that address safety, efficacy, and payment concerns in parallel to help get lifesaving drugs into the hands of patients faster while simultaneously solving reimbursement issues.
In a related space, orphan drugs, used to treat rare diseases, also pose regulatory and reimbursement challenges. Pharmaceutical companies receive government financial incentives to research these personalized treatments, as they are reluctant to shift away from developing more universal, “blockbuster” drugs. Even still, the prices for these drugs are rising, sparking conversations about how best to regulate pricing in the market.
Amato says these regulatory challenges of pricing and access are not going away any time soon. There are six additional life-saving gene therapies slated to be approved in 2018, and another 250 associated clinical trials underway in the U.S. alone. For regulatory professionals, this is an issue worth following.