From jsonline: Food and Drug Administration Commissioner Margaret Hamburg continued to get flak Thursday over her agency's approval of the powerful new narcotic painkiller Zohydro, culminating with the introduction of a U.S. Senate bill that would revoke the agency's approval of the drug.
In the latest volley, Hamburg went before a Senate committee where she got more questions about the drug, which does not have an abuse deterrent formula and is the first hydrocodone-only opioid. Hydrocodone is the narcotic in drugs such as Vicodin, which in the past had always been combined with over-the-counter products such as acetaminophen.
Even before the committee hearing, Hamburg was confronted by Sen. Joe Manchin (D-W.Va.) about the agency's approval of Zohydro last fall. Manchin also has raised concerns about alleged pay-for-play meetings that were financed by drug companies. Those meetings, which were attended by drug company executives and FDA personnel, helped influence FDA policy on the development of new pain treatments.
The private meetings were the subject of a Milwaukee Journal Sentinel/MedPage Today investigation. One initiative that sprang from the meetings was a controversial new way to test pain drugs. The method, known as enriched enrollment, was used to win approval for Zohydro.
Manchin introduced a bill that would withdraw the FDA's approval of the drug and prohibit the agency from approving other such drugs without an abuse-deterrent formula.
Read more from Journal Sentinel: http://www.jsonline.com/news/health/fda-official-catches-more-heat-over-ok-of-painkiller-zohydro-b99224570z1-250224631.html#ixzz2vuqLfP7a
The Senate is not qualified to determine if this drug is useful or not. The Senate has a bunch of brain dead phonies who are not intelligent enough to determine what 2+2 equals, much less any other issue. And this goes for both parties, Democrats and Republicans.
Let the FDA so their job and keep the U.S. Senate out of it.
Sunrise — 7:03.
12 hours ago
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