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Friday, Mar 25 2016

Full Issue

FDA Encourages Generic Drugmakers To Develop Harder-To-Abuse Painkillers

The agency has approved five brand-name drugs that are designed to deter abuse -- such as being hard to crush -- but those represent a small fraction of the field that is dominated by less expensive generics.

The Food and Drug Administration on Thursday gave guidance to support the development of generic versions of approved abuse-deterrent opioids, the agency’s latest step to reduce deaths from abuse of the powerful drugs. As the FDA pushes the industry to develop pain medicines that are more difficult or less rewarding to abuse, it is recommending studies to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product. (Steele, 3/24)

The Food and Drug Administration published draft guidelines outlining testing standards for harder-to-abuse generic painkillers. The agency has already approved five brand-name opioid pain drugs which are designed to discourage abuse. The current version of OxyContin, for example, is difficult to crush, discouraging abusers from snorting or dissolving the tablets to get high. But these abuse-deterrent painkillers represent a small fraction of the market for opioid pain drugs, which is dominated by low-cost generics. (3/24)

Meanwhile, a new survey shows that 99 percent of doctors overprescribe opioids, and, in Massachusetts, a rising number of drug-dependent babies are being born —

Ninety-nine percent of primary care doctors routinely prescribe potentially addictive opioid painkillers for longer than the three-day period recommended by the Centers for Disease Control and Prevention, according to survey results released Thursday by the National Safety Council. (Keilman, 3/25)

Massachusetts hospitals are seeing evidence that the opioid epidemic is affecting the next generation, with an increasing number of babies being born exposed to drugs. The most recent state hospital data suggest that the rate of drug dependent newborns has skyrocketed to about 16 in every 1,000 births — about three times the national average. (Becker, 3/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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