Representatives Rosa DeLauro (D-CT), Harold Rogers (R-KY) and Stephen Lynch (D-MA), today questioned the Food and Drug Administration (FDA)’s approval of a potentially dangerous and powerful new opioid despite the risks that it presents to public health. In a letter to Department of Health and Human Services Inspector General Daniel Levinson, they ask him to examine the relationship between industry and the FDA in facilitating the approval of Zohydro at the expense of public health and consumer safety.
The drug, Zohydro ER, contains five to ten times more hydrocodone than any drug currently available on the market. In its approved formulation, the drug is easily abused. It was approved by the FDA in October, despite a FDA advisory committee previously voting overwhelmingly against its approval.
“FDA Advisory Committees seldom vote against approval, and such overwhelming opposition is even rarer,” the representatives wrote. “Given the Committee’s lopsided vote and experts’ strongly expressed concerns about the public health implications of approving this drug before better safeguards are in place to reduce abuse, Zohydro ER’s approval raises several questions…Ensuring that patients and consumers are protected against dubious ethical involvement of corporate pharmaceutical interests in the regulatory process helps to ensure public health is protected. This requires transparency. Accordingly, this matter requires closer inspection.
The text of the letter can be found here.