Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Digital Health Legal, in “FDA Approves First Drug with Digital Ingestion Tracking System.”

Following is an excerpt (see below to download the full version in PDF format):

The drug, the result of a joint venture between Otsuka Pharmaceutical, Inc., and Proteus Digital Health, utilizes 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. …

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.”

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.