Despite experts voicing their concerns, Zohydro, a powerful, new painkiller hits the US market this week. Some consider the sale of this medication a significant setback in terms of the country’s struggle with opioid addiction. Online sources indicate approximately 15,000 people die every year from prescription painkiller abuse or misuse.
The FDA (US Food and Drug Administration) has already begun an investigation with the aid of a pair of senators. Now allegations have arisen that bear some investigation. It’s been claimed by unnamed sources that the painkiller market might have paid billions to influence regulators’ decisions. Zohydo, the drug itself, was green lighted by the FDA back in October 2013.
The drug was approved despite a panel of experts brought together by the FDA. The group actually voted against the release 11-2. The FDA, however, not being required to take the advice of the advisory committee, chose to OK Zohydro anyway.
While a spokesman for the FDA reported that the decision to approve the drug was make only after very careful consideration. They also believed that Zohydro’s advantages outweigh any potential risks if used as intended. While it is true that it contains uncut hydrocodone, it also includes some options regarding time-release that are stronger than similar products produced by the competition. Furthermore, it doesn’t contain any acetaminophen which can damages the liver. Many of the other available prescription opioids do contain it.
Now MedPage Today reports that someone at the FDA was possibly paid thousands of dollars by unnamed pharmaceutical companies for a seat on an FDA advisory panel meeting. Senators Joe Manchin (Democrat/West Virginia) and David Vitter (Republican/Louisiana) have launched an investigation to learn the truth behind these alleged “pay-to-play” meets with the FDA officials who supervise safety regulations on painkillers. The political pair point out that these alleged meetings could have given certain drug companies “undue influence over FDA’s approval process for prescription painkillers.” The FDA has denied any alleged impropriety.
(Image courtesy of ALW/PAD)