Patient safety? Nah I’m good

When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”

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FDA: Endo’s opioid is a no-no, has got to go

For the first time, the FDA is requesting that a drug maker remove its product from the market for public health reasons. Endo Pharmaceuticals’ Opana ER—an opioid designed to continuously manage moderate to severe pain—has already faced scrutiny for being easy to abuse via snorting. Turns out addicts aren’t too fond of the ‘extended’ aspect of the drug. To combat this, the company added a coating that made the drug harder to crush… so abusers injected it instead. Not only did this reformulation not meet the FDA’s standards of officially being abuse-deterrent, but the rise in injection abuse is also tied to an HIV/Hep C outbreak caused by needle sharing. God save us from people who mean well.

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Counting down to counting calories… eventually

The FDA has again delayed implementation of its requirement for food sellers (supermarkets, chain restaurants, etc.) to post calorie counts of food items on their menus. Originally set to go in effect on May 5, the affected businesses now have until May 7, 2018 to get calorie counts up. While some trade groups representing the industry are happy to see this get delayed, they’re also hoping that a regulation-averse White House will either weaken the requirement, or do away with it altogether. There are certainly some valid criticisms of the requirement, especially in regard to how the hell sellers without menus are supposed to be labeling their products (like convenience stores already starved for space,) however, there’s also things like this to consider.

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2. Can you hear me now? Good.

In accordance with a new policy released last Wednesday, the FDA has increased patient accessibility to hearing aids. The guidance, which takes effect immediately, removes the requirement of medical evaluation or waiver-signing before buying a hearing device. The agency also said they’ll consider creating a category for OTC hearing aids. So go ahead and prepare yourself now for some campy, elderly-consumer-focused commercials. The move was done in part to encourage industry innovation/competition to create cheaper hearing devices, which would also serve to increase access for the 30 million Americans who live with hearing loss. That’s something we can all get behind, right? Hear, hear!

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2. Pay no attention to the CSRs behind the curtain

In a move lauded by clinical trial transparency activists, the EMA has begun to release  the full clinical study reports (CSRs) submitted for drug approval on their website. These aren’t the paired-down, not-quite-as-public-relations-focused-as-a-press-release-but-still-not-the-whole-picture versions submitted in scientific journals, and they include all the info a sponsor might not want to publish themselves—like the details of a drug’s adverse effects. The reports will be redacted for patient data and commercially confidential information, and the EMA will be retroactively posting CSRs for products (approved, or otherwise) submitted to the agency for review since Jan. 1, 2015. In the meantime, maybe try some light reading with the 260,000 pages released so far.

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