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.
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.
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!
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.
Would you pay 25% more for your prescription medications if your pharmacy could guarantee the medications were manufactured in your home country? OR, if you live in a country where you do not pay for your prescriptions, would you be willing to pay out of pocket for this guarantee?
The Department of Health and Human Services released new policies Friday aimed at improving clinical trial access for the general public. AKA, the reason why clinicaltrials.gov was created. Turns out not everyone has been participating equally in the project though—a 2014 study reported that 30 percent of trials don’t publish information to the site. Vice President Joe Biden is annoyed. In June he even threatened to cut off funding to noncompliant institutions. Friday’s policies expand the types of studies that must be reported on, ask for faster registration of trials and generally require more detailed information about the research. See what you did researchers? You didn’t listen to the teacher the first time and now you have even more homework. Classic mistake.