This is highly significant. The FDA turned its back on its own panel of new-drug reviewers.
Senator Manchin continues:
“Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public… [Zohydro] has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted, and injected.”
In other words, Zohydro, used as a pain killer, is a nightmare. If you’ve ever taken Vicodin, imagine a pill with ten times the strength.
“In his letter, Manchin raised questions about the drug’s approval. ‘I am deeply troubled that the reason for Zohydro ER’s approval may be linked to allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars for the privilege to attend private meetings with FDA officials,’ he wrote, citing news reports. ‘Allegations have been raised that a new, scientifically questionable methodology for drug approval was created at these pay-to-play meetings.’”
“The FDA has denied any improprieties regarding those private meetings, which the agency has said were intended to help the FDA better evaluate evidence from clinical trials.”
Then let’s see every word of those private meetings. The FDA is a public agency. Let’s see exactly what went on in those secret meetings.
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