Product News and Recalls

Senators call for Zohydro investigation

According to The Hill, two senators are investigating allegations that “members of the pharmaceutical industry” paid large sums of money to meet with FDA officials in connection with its recent approval of Zohydro.

The Hill reports that Senators Joe Manchin, (D-WV) and David Vitter (R-LA) have written letters to the FDA and others who may have been involved. According to the letter, multiple pharmaceutical companies paid $25,000 to $30,000 to a university hospital to meet with FDA officials.

Reports such as this raise concerns about an already controversial drug. An FDA panel voted by an overwhelming majority not to approve Zohydro, but the FDA recently gave the green light. Meanwhile state Attorney Generals and various healthcare organizations have called for the FDA to reconsider its decision.

If a pharmaceutical company exercised improper influence to get Zohydro approved, it calls into question whether the risks and benefits are properly described in the prescription label. If information was withheld, it could lead to unnecessary injury or death, because doctors and patients will not be able to properly weigh Zohydro’s risks and benefits.

Lopez McHugh will be monitoring reports about Zohydro. Because it was recently approved, it may take some time to learn and understand whether this potent drug is causing unnecessary injury.