Good morning, everyone, and welcome to a new year. We hope the extended respite — for those of you who were able to enjoy — was refreshing and relaxing, because the inevitable routine has unsurprisingly returned. So please join us as we hoist a cup of stimulation to a year of fresh challenges that await. Meanwhile, here are some tidbits to help you ease in. Hope your day goes well and you find it manageable.

Newly unearthed documents show the Food and Drug Administration failed to use its policing powers to make sure a program to curb improper prescribing of opioids was effective, The New York Times writes, citing research in JAMA. In 2011, the FDA asked the makers of OxyContin and other addictive long-acting opioids to pay for safety training for more than half the physicians prescribing the drugs, and to track the effectiveness of the training and other measures in reducing addiction, overdoses, and deaths. But the FDA was never able to determine whether the program worked

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  • Concerning the final SUN Pharma article re the Halol 483, the (financial?) analysts who are concluding that these issues are ‘not so serious’ must not have read the 483 in question – or they are making a ‘buy on the dip’ recommendation. This is a case where a review of the ‘raw data’ is in order: https://www.fda.gov/media/133737/download [pdf – 3 Mb]

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