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Volume: 4 Issue: 12
(December 2017)

Keywords:
fd approves first drug digital ingestion tracking system us food drug administration (‘fd announced 13 november 2017 approved abilify

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FDA approves first drug with digital ingestion tracking system

The US Food and Drug Administration (‘FDA’) announced on 13 November 2017 that it has approved Abilify MyCite, the first drug in the US with a digital ingestion tracking system, a development that has caused excitement due to the potential commercial and health implications, but has also caused concern relating to possible privacy issues.

The drug, the result of a joint venture between Otsuka Pharmaceutical, Inc., and Proteus Digital Health, utilises a sensor to detect whether the patient has ingested the medication and relays information - such as the time the pill was taken - to a patch worn on the patient’s ribcage, which is then transferred to a mobile app on the patient’s smartphone. Caregivers and physicians can, with the patient’s consent, access such information through an online portal.

“This is a monumental commercial development,” believes Kevin M. Madagan, Partner at Reed Smith LLP. “Not only does it bring us one step closer to the full integration of digital health throughout a patient’s course of therapy, but it also has the potential to transform the way in which the United States protects its citizens from harm. Take patient compliance, as an example. This technology will undoubtedly impact therapeutic areas where patient compliance is a concern.”

The FDA has approved the product for treating ‘schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults,’ but notes that the prescribing information for the drug states that it is not for tracking drug ingestion in ‘real-time’ or during emergencies. Further, it notes that the product’s ability to improve the compliance of patients with their treatment regimen has not been shown. “Obviously the sensor’s manufacturer has big plans to work with other pharmaceutical companies. It is targeting a wide variety of chronic conditions,” notes Bradley Merrill Thompson, Member at Epstein Becker & Green, P.C. “But the FDA action stopped short of saying that the product has been shown to improve patient compliance with their treatment regimen. And that’s where companies such as these will need to go in order to get payers excited. Collecting data for the sake of data is not a long run strategy. They will have to demonstrate improved outcomes. So I would say that the [FDA] decision in November was an incremental step. The device had already been approved, so this is simply the approval of the drug with the device, but without the claim of improving patient compliance there is still much work to be done.”

Reaction to Abilify MyCite’s approval by the FDA has included hopes that such technology might assist in tackling problems around patients failing to take the medication prescribed to them as physicians and caregivers will be aware if the correct treatment regimen is being followed, but other commentators have expressed concern about possible privacy risks presented by the drug tracking users’ behaviour. “There have been criticisms of this technology in terms of ‘Big Brother is watching,’” said Diane Romza-Kutz, Partner at Thompson Coburn LLP. “However, the consent process by the patient as to who can access information may limit some of this criticism.”

“One of the most interesting issues that is not discussed in the press releases about the approval is how the FDA’s guidance documents on cyber security issues and other software-related guidance will be applied,” adds Romza-Kutz. “Further the FDA has taken a non-enforcement stance on some mobile medical applications depending on what the use is. It is not clear as to how the agency will handle the mobile medical application of this technology at this point.”

The Wall Street Journal reported on 13 November that in order to process an anticipated significant number of requests for similar products, the FDA is seeking to hire more staff with a “deep” understanding of software development in the medical device area.

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