Manchin Questions FDA Commissioner on his Complicity in the Drug Epidemic

Washington, DC – Today, U.S. Senator Joe Manchin (D-WV), member of the Senate Appropriations Committee, questioned the U.S. Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, on his continued complicity in the drug epidemic for using flawed opioid trial methodology and allowing disproportionate pharmaceutical influence on agency decision-making.

 

“The FDA is holding an Advisory Committee meeting on opioids today, in particular, the questionable clinical trial practice known as enriched enrollment. The agenda today has a majority of speakers who attended the very questionable IMMPACT meetings… I find it imperative that this Advisory Committee has non-ideological presenters to avoid the appearance of industry influence on decision-making, and it very much appears that there is a heavy emphasis on the industry today,” Senator Manchin stated.

 

“The External Review of FDA Regulations of Opioids report recommended the FDA be as transparent as possible regarding decision-making… Dr. Califf, you recently have been pushing to reduce voting at the FDA Advisory Committee meetings, even stating in a MedPage Today interview, that ‘voting doesn't matter.’ How does ending voting for the Advisory Committee meetings improve the transparency and the public trust that you advocated for?” Senator Manchin continued.

 

 

The FDA uses a clinical trial methodology known as “enriched enrollment” (EERW) to approve opioids. This process has been shown to skew results and seriously underestimate risks associated with the proposed drug. EERW was originally recommended in the early 2000s and 2010s through IMMPACT meetings, which charged pharmaceutical companies $15,000 to $35,000 a piece for access to FDA officials.

 

External reviews required by the FDA Review of Efficacy of EERW Double-Blinds (FREED) of Opioids Act, which Senator Manchin secured in the FY23 year-end funding bill, as well as a report the FDA ordered itself have stated that they should “revisit the use” of EERW, citing that there are several limitations that warrant additional consideration for its use in approving opioids. However, this methodology is still in use.

 

During an FDA Advisory Committee meeting today, experts were allowed to participate at the end and testify on EERW trials being conducted. Some of the public comments are below.

 

“FDA commissioned a report on its handling of opioids. The mostly favorable report did criticize FDA in one area- its reliance on EERW design for opioid approvals. It pointed out that FDA’s decision to allow EERW grew out of improper private meetings with drug makers. There are fairly obvious problems with EERW design,” said Dr. Andrew Kolodny, President of Physicians for Responsible Opioid Prescribing and Medical Director for the Opioid Policy Research Collaborative at the Heller School at Brandeis University.

 

“The EERW study designs being considered have fundamental flaws and will not be generalizable to most chronic pain patients. And so, the people who manufacture, sell, or prescribe opioids are most likely to benefit, not the patients,” said Diana Zuckerman, Ph.D., President of the National Center for Health Research.

 

“The single most important action the FDA should take, one that is long overdue, is to rein in the label of long-acting opioids so that it reflects the scientific evidence regarding these products. With that said, while the FDA has committed to a new, fresh approach to opioid regulation, it is hard to see how the proposed study represents anything but more of the same. Any future [long-acting opioid] trial should avoid using an EERW design. Frankly, it is striking that the Agency would even consider such a design in 2023, given that it cherry-picks winners and yields highly uninformative conclusions regarding general efficacy, let alone effectiveness. With more than 280,000 lives lost from prescription opioids, it is time that the FDA started holding opioid makers accountable and addressing the critical scientific questions that the American public is waiting for,” said G. Caleb Alexander, MD, MS, Founding Co-Director, Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health.