FDA approves first digital pill to track patients - WRCBtv.com | Chattanooga News, Weather & Sports

FDA approves first digital pill to track patients

Posted: Updated:

By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) - U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify - long used to treat schizophrenia and bipolar disorder - with a sensor tracking system first approved in 2012.

The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder.

But developers Otsuka Pharmaceutical Co. and Proteus Digital Health are likely to face hurdles. The pill has not yet been shown to actually improve patients' medication compliance, a feature insurers are likely to insist on before paying for the pill. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information.

These privacy issues are likely to crop up more often as drugmakers and medical device companies combine their products with technologies developed by Silicon Valley.

The new pill, Abilify MyCite, is embedded with a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient and notifying a digital smartphone app that the medication has been taken.

The FDA stressed however that there are limitations to monitoring patients.

"Abilify MyCite should not be used to track drug ingestion in 'real-time' or during an emergency," the statement said, "because detection may be delayed or may not occur."

Patients can track their dosage on their smartphone and allow their doctors, family or caregivers to access the information through a website.

In a statement issued last May at the time the FDA accepted submission of the product for review, the companies said "with the patient's consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs."

While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the U.S. have previously "packaged" various drugs and sensors. But the federal endorsement increases the likelihood that insurers will eventually pay for the technology.

Drugmakers frequently reformulate their drugs to extend their patent life and to justify raising prices. For instance, Otsuka already sells a long-acting injectable version of Abilify intended to last for one month. The patent on the original Abilify pill expired in 2015.

The Japanese drugmaker has not said how it will price the digital pill. Proteus Digital Health, based in Redwood City California, makes the sensor.

___

Merrill Hartson in Washington contributed to this report.

Copyright 2017 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

WEEKLY CIRCULARS
  • NewsMore>>

  • TVA working on transmission lines

    TVA working on transmission lines

    Tuesday, April 24 2018 2:40 AM EDT2018-04-24 06:40:02 GMT
    TVA crews working on transmission lines starting Tuesday, April 24.More
    TVA crews working on transmission lines starting Tuesday, April 24. More
  • Remembering the victims of the Antioch shooting

    Remembering the victims of the Antioch shooting

    Monday, April 23 2018 1:24 AM EDT2018-04-23 05:24:32 GMT
    Monday, April 23 2018 11:52 PM EDT2018-04-24 03:52:20 GMT
    Four people were killed in the shooting early Sunday morning. (WSMV)Four people were killed in the shooting early Sunday morning. (WSMV)

    Police have identified the four victims killed at the Waffle House on Murfreesboro Pike early Sunday morning, all of whom were under 30 years old: Taurean Sanderlin, Joe Perez, DeEbony Groves, and Akilah Dasilva.

    More

    Police have identified the four victims killed at the Waffle House on Murfreesboro Pike early Sunday morning, all of whom were under 30 years old: Taurean Sanderlin, Joe Perez, DeEbony Groves, and Akilah Dasilva.

    More
  • 'It was life or death,' says man who snatched gunman's AR-15

    'It was life or death,' says man who snatched gunman's AR-15

    Sunday, April 22 2018 11:15 PM EDT2018-04-23 03:15:12 GMT
    Monday, April 23 2018 8:09 PM EDT2018-04-24 00:09:52 GMT
    (Larry McCormack/The Tennessean via AP). James Shaw Jr., shows his hand that was injured when he disarmed a shooter inside a Waffle House on Sunday, April 22, 2018, in Nashville, Tenn.   A gunman stormed the Waffle House restaurant and shot several peo...(Larry McCormack/The Tennessean via AP). James Shaw Jr., shows his hand that was injured when he disarmed a shooter inside a Waffle House on Sunday, April 22, 2018, in Nashville, Tenn. A gunman stormed the Waffle House restaurant and shot several peo...
    The man who wrestled the gun away from the Nashville's Waffle House shooting suspect says he decided if he was to die, gunman would "have to work to kill me.".More
    The man who wrestled the gun away from the Nashville's Waffle House shooting suspect says he decided if he was to die, gunman would "have to work to kill me.".More
Powered by Frankly