Pubdate: Fri, 25 Mar 2016
Source: Day, The (New London,CT)
Copyright: 2016 Associated Press
Contact:  http://www.theday.com/
Details: http://www.mapinc.org/media/293
Author: Matthew Perrone, AP Health Writer

FDA URGES SAFER GENERIC PAINKILLERS

Officials Embracing Tactic to Fight Addiction

Washington - Federal officials are encouraging generic drugmakers to 
develop painkillers that are harder to abuse, the latest in a string 
of steps designed to combat abuse of highly-addictive pain drugs like 
codeine and oxycodone.

The Food and Drug Administration published draft guidelines outlining 
testing standards for harder-to-abuse generic painkillers. The agency 
already has 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.

Generic drugs receive a streamlined review process at the FDA, which

helps speed their path to market and reduce the prices for consumers. 
Generally, manufacturers only need show that their products are 
chemically equivalent to the original version.

The FDA draft guidelines released Thursday make clear that companies 
will need to perform additional studies showing that generic opioids 
have the same anti- abuse properties as their brand-name counterparts.

FDA officials said there is no timeline for updating 
currently-available generic opioids to abuse-deterrent versions.

Thursday's proposal comes just days after the FDA said it would add a 
new boxed warning - the most serious type - to some 175 
immediate-release painkillers, including both branded and generics.

That action is one in a series of measures promised by new FDA 
Commissioner Dr. Robert Califf, who was confirmed by the Senate last month.

Califf 's confirmation was held up by Senate lawmakers who said the 
agency needed to do more to combat opioid abuse. For years, the 
agency only made modest changes to the drugs, emphasizing the need to 
keep medications accessible to patients with chronic pain.

In its announcement, the FDA acknowledged that evidence on the 
benefits of abuse-deterrent opioids still is emerging.

[sidebar]

PANEL: DECRIMINALIZE, REGULATE DRUGS

A group of 22 medical experts convened by Johns Hopkins University 
and The Lancet have called this week for the decriminalization of all 
nonviolent drug use and possession. Citing a growing scientific 
consensus on the failures of the global war on drugs, the experts 
further encourage countries and U.S. states to "move gradually toward 
regulated drug markets and apply the scientific method to their assessment."

Their report comes ahead of a special U.N. General Assembly Session 
on drugs to be held next month, where the world's countries will 
re-evaluate the past half-century of drug policy.

In a lengthy review of the state of global drug policy, the 
Hopkins-Lancet experts conclude that the prohibitionist anti-drug 
policies of the past 50 years "directly and indirectly contribute to 
lethal violence, disease, discrimination, forced displacement, 
injustice and the undermining of people's right to health." The 
commissioners also fault U.N. drug regulators for failing to 
distinguish between drug use and drug abuse.

The commissioners point to successes in drug decriminalization 
experiments in places like Portugal, where drug use rates have 
fallen, overdose deaths are rare and new HIV infections among drug 
users have plummeted. They recommend that other countries adopt a 
similar approach.

And beyond decriminalization, the commissioners recommend 
experimenting with the full legalization and regulation of certain 
types of drug use, as several U.S. states have done with marijuana.

- - The Washington Post
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MAP posted-by: Jay Bergstrom