Senator seeks anti-Zohydro legislation
Regulatory Focus reports that the Democrat from West Virginia has sponsored the "Act to Ban Zohydro" bill, which would require the drug to be pulled from the market within 45 days if it clears both Congressional chambers.
RF says Manchin's move is a standout for two reasons, the first being that the publication cannot find any regulatory history in which an act of Congress has overturned an FDA decision. RF notes that Congress tried and failed to pass legislation against RU-486, which is used in abortions, in 2003.
The line of anti-Zohydro activity includes Manchin's proposed bill as well as a series of letters from senators including ones from New York Democrat Charles Schumer and Senate Majority Leader Mitch McConnell (R-Kentucky).
Twenty-eight attorneys general have also pressed the FDA to change its mind, but the regulator, which is a subset of the Department of Health and Human Services, is standing firm: FDA Commissioner Margaret Hamburg defended her agency's approval of Zohydro before the Senate Committee on Health Education, Labor and Pensions Committee last Thursday. “We recognize that it is a powerful drug, but we also believe that if effectively used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy,” she told the panel.
Contributing to the Zohydro uproar is a marked uptick in painkiller prescriptions and abuse that has put local communities on edge. Critics say Zohydro runs counter to efforts to curb use and abuse because its formulation does not inhibit a user's ability to manipulate the drug to get high. Regulations have created an environment that allows drugmakers to push a branded drug off the generics pathway if the manufacturer can make a more abuse-resistant version. Purdue Pharma has successfully played this angle, while Endo has not.
Scrutiny has not deterred innovators, as seen by Friday's news that the FDA approved Mallinckrodt's opioid painkiller Xartemis. This controlled release oral oxycodone-acetaminophen combination was approved for acute pain for patients who cannot take non-opioid alternatives.
Mallinckrodt acknowledges in a statement that the label does not include any abuse-deterrence formula information but says it “will continue working closely with the FDA to develop more data to characterize abuse-deterrence features of Xartemis XR,” which uses Depomed's Acuform drug delivery technology.