In October 2013, the Milwaukee Journal Sentinel disclosed that the University of Rochester created two organizations: IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) and ACTTION (Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks). Some alleged potential pay-to-play arrangements involving meetings between pharmaceutical industry representatives and FDA officials occurred with these organizations. Pharmaceutical industries allegedly paid between $20,000 and $35,000 to send one representative to a two-day meeting. Zohydro ER’s original manufacturer may have participated in those meetings. Allegedly as a result of the meetings, the FDA approved a method, known as enriched enrollment, which allowed pharmaceutical companies doing pain studies to remove certain patients who did not respond well to a medication or could not tolerate it before the study began. This made it much easier for pharmaceutical companies to prove their medications were safe and effective.

On March 10, 2014, several senators called for a special investigation into these pay-to-play allegations against several pharmaceutical companies, physicians, and FDA officials. Sen. Joe Machin (D- WV) and Rep. Stephen Lynch (D-MA) introduced legislation to prohibit the FDA from approving similar drugs unless they are formulated to prevent abuse. Several Republican senators also demanded the FDA release safeguards to prevent abuse.

In March, Purdue Pharma announced it had developed a tamper-resistant version of its hydrocodone product for extended release. Interestingly, the company that markets Zohydro ER announced it will likely have a tamper-proof version of Zohydro ER ready by 2016.

On April 15, 2014, a US District Court issued a preliminary injunction citing that the ban ordered by Massachusetts Gov. Patrick was unconstitutional.

The investigations are just beginning, and the controversy will undoubtedly continue. It is an unintended, and unfortunate, coincidence that Zohydro ER happens to have the word “ER” in it.

Dr. Kivela is managing partner at Napa Valley Emergency Medical Group, medical director of Medic Ambulance, and part owner of Elan Medical Corporation. He is also the secretary-treasurer of the ACEP Board of Directors.