Quality standards are necessary to help promote adoption of the novel class of interventions called digital therapeutics. This rapidly emerging industry needs to bring together regulators, engineers, practitioners, and companies to agree on definitions that enable innovation, according to product development and regulatory specialists. As the digital transformation sweeps through healthcare, industry experts say that new classes of medicines and therapeutics present extremely promising opportunities. These interventions have the possibility to achieve the remarkable combination of “driving down costs and empowering consumers to take charge of their health” says Donald Jones, Chief Digital Officer of the Scripps Research Translational Institute (SRTI). “Digital therapeutics rely on high quality software to deliver evidence-based interventions to patients to prevent, manage, or treat disease” says Megan Coder, the Executive Director of the Digital Therapeutics Alliance, an industry trade organization. “They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” Examples of companies developing such products include Pear Therapeutics, which has the first FDA approved software-based therapy for addiction. Akili Interactive is developing a prescription digital medicine for behavior disorders. Proteus Digital Health has an approved digital product to track adherence. Voluntis has a prescription product to manage diabetes. Therapeutic products approved and marketed in the US must meet certain legally established standards. Most people are familiar with the role of the Food and Drug Administration (FDA). This powerful regulatory agency ensures that drugs and medical devices have clearly demonstrated safety and efficacy. The FDA reviews lengthy submissions that contain extensive details about human clinical trials, animal safety testing as well as assurances of manufacturing rigor to determine if products are safe and effective. Quality standards However, a lesser known requirement is that drugs also must meet quality standards. “Regulatory is sexy and quality is not” says David Amor, Vice President of Quality and Regulatory Affairs at Pear Therapeutics. The standard-bearer for drug quality is United States Pharmacopeia (USP), a Washington-based non-profit that develops public guidelines working with expert volunteers from regulatory agencies, industry, and academia. “We want to establish trust so practitioners can feel safe using novel interventions including digital therapeutics,” says Ronald T. Piervincenzi, Ph.D., the CEO of USP. He states that USP evaluates latest industry practices, updating standards and responding to emerging needs. Being up to date on healthcare trends through collaboration with key stakeholders enables USP to be timely with its public standards development process. This helps decrease time to bring new therapies to market and “shorten the innovation curve” by creating a foundation of trust, reliability and quality for new products, says Piervincenzi. Most drugs are made of chemicals which can be quantified and analyzed. Yet the building blocks of digital therapeutics are software, hardware and telecommunications platforms. Specialists at USP recognize the challenge of applying quality standards that are commonplace for drugs to the new category of therapeutic software. USP uses four criteria for drug quality which are Identity, Strength, Purity and Performance. Identity defines and allows the verification of a chemical based on analytical methods. Strength is a measurement of the amount of drug present. Purity determines if there is anything unexpected in the pill. Performance defines the ability of the drug to have the expected effect by dissolving properly in the body. Applying drug standards to software and digital therapeutics is difficult and borders on a philosophical challenge. Yet there are real risks. “Without established standards and verifications, these products could be falsified by unscrupulous actors,” says Michael Levy, Vice President, Head of Quality Institute and Head of Research & Innovation at USP. He states there are significant differences between the way chemical medicines and digital therapeutics are developed. “The act of designing software is difficult, just like developing medicine. The rigor should be analogous to Good Manufacturing Practices, which must be used for medicinal products,” says Levy referring to the FDA's formal regulations regarding design, monitoring and control of drug production. Joris Van Dam, the Head of Digital Therapeutics at Novartis, says early software testing could be considered similar to preclinical studies in drug development. Citing the classic approach for drugs, he says, “pharmacokinetics is like usability, and pharmacodynamics is like user engagement testing.” USP history USP was started in 1820 by eleven physicians who recognized the concerns around uniformity of medicines prepared across the young country. The founders met in the US senate chamber to create a pharmacopeia that set standards for quality. It was essentially a book of recipes for medicines. USP is now approaching its 200th anniversary and has since engaged in the timely adoption of emerging technologies to develop trusted quality methods. It develops and publishes standards for quality medicines, excipients, and dietary supplements in a published national compendium. USP standards are also used in 140 countries around the world. The process was codified in the Federal Food, Drug and Cosmetic (FD&C) Act enacted in 1938. Now expert panels made up of volunteers from academia, practices, industry, as well as representatives from the FDA, regularly work with USP staff to review and create quality standards for medicines.
the US Food & Drug Administration therapeutics will need to meet quality standards like those required by conventional drugs. Although such novel treatments are gaining approval by Digital , another requirement is compliance with quality standards from United States Pharmacopeia (USP), which will be challenging. The USP is looking to introduce standards that will enable doctors to confidently use the new treatments, said Novartis , CEO of USP. Novartis , head of digital therapeutics at Novartis , said early software testing could be likened to preclinical studies for drugs.