The Food and Drug Administration (FDA) last week accepted for review a New Drug Application (NDA) from Otsuka Pharmaceutical and Proteus Digital Health to create a new digital pill by embedding a newly developed digital sensor in the drug ABILIFY, marking a major breakthrough for the digital health industry.
Proteus Digital Health has developed an ingestible sensor that can detect when the drug within which it is embedded, in this case ABILIFY, has reached the stomach, transmitting the information via a wearable patch to a mobile device. The new digital pill would also be capable of measuring a patient's physiological data.
Commenting on the development Melissa Bianchi, Healthcare Regulatory and Privacy partner in Hogan Lovells digital health team, said:
"This is a hugely important development for the digital health sector. Such ground-breaking technology could significantly benefit both patients and clinicians, helping patients follow their prescribed dosage.
"Even more exciting is the potential to take the technology a step further so that future digital medicines can permit real-time monitoring of patient health.
"If approved, it will be the first medication to carry an ingestible sensor, so called "digital medication", to be marketed in the U.S. and would surely revolutionize the industry as we know it."
The integration of consumer-focused digital applications and medical devices is changing the way healthcare professionals interact with patients and is driving more effective and efficient treatment.
New technologies such as this also raise various business and legal concerns, however as issues presented by the opportunities are not always easily addressed within the borders of traditional areas of law and local regulation.
Commenting on the complexities of FDA regulatory partner Yarmela Pavlovic said:
"While sensors like this have previously been approved as standalone medical device tools when not embedded, the new approach treats the sensor as a combination drug/device product requiring close collaboration by pharmaceutical and medical device regulators. From a technical standpoint, the new approach also raises unique technical issues including the impact of the sensor on the medication."
EU healthcare regulatory partner Elisabethann Wright added:
"Combining the rules governing medicinal products with those governing medical devices, an essential step in any review of the quality, safety and efficacy of the digital pill, could give rise to interesting challenges. It will necessitate an examination of the pharmacological effect of the medication, the mechanical action of the device, and the combined effect of the two. It may be challenging to identify the required combined expertise in the same department of a national authority."
Andreas von Falck, Head of Hogan Lovells intellectual property practice, noted the need for companies to protect their new technologies:
"Combining existing drugs with new delivery systems is an area of fast increasing importance. It opens up very interesting avenues towards effective intellectual protection where either one of the two elements in the combination is protectable or the combination itself is a patentable invention. Effective patent protection is a key factor in ensuring that the investment made into a new product is appropriately protected."
It is not only the conceived technologies that require protection, but also their makers and distributers, acknowledged product liability partner Lauren Colton:
“As with any medical device or pharmaceutical product, digital medications carry with them the traditional product liability risks associated with defective design, manufacturing or warnings. However, this new technology carries additional risks that are not usually involved in medical device or pharmaceutical product liability actions as a result of the digital pill’s ability to measure a patient’s physiological data. The question becomes what duty, if any, does the manufacturer have upon receipt of the data? Does the manufacturer have a duty to convey any potentially adverse medical conditions to a patient or the prescribing physician? If so, does that open the company up to additional negligence theories based upon the practice of medicine? Because this is the first such digital medication, however, the precise theories that may be developed by plaintiffs’ attorneys remain to be seen.”
Eduardo Ustaran, data privacy partner, highlighted another key issue for businesses is the sharing of data new technologies such as the digital pill provide:
"There is a fine line between maximising the value of data and respecting the privacy expectations of users and regulators. Given the evolving data protection framework in Europe, embedding a 'privacy thinking by default' approach will become the only safe way of ensuring compliance in a business-friendly way."
The collection of and access to this information will dramatically change the way in which drugs and devices are developed, approved, reimbursed and marketed, and the way healthcare services are delivered.
These changes will improve the way in which the pharmaceutical and medical device industry, healthcare providers and healthcare payors interact with and provide services for patients; it will also streamline distribution systems, and make personalized treatments available more easily and more widely.
The potential benefits of developments in digital health clearly outweigh the challenges and concerns the industry will face in implementing and reacting to them. At the intersection of business and government, Hogan Lovells is ideally placed to advise clients as they innovate and navigate, breaking new ground in the digital health space.