May 08, 2024

Manchin Questions FDA Commissioner On Opioid Approval Process, Domestic Production Of Antibiotics

Washington, DC – Today, U.S. Senator Joe Manchin (D-WV), member of the Senate Appropriations Committee, questioned Dr. Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), on addressing the FDA’s flawed methodology in approving new opioids, removing outdated opioids from the market and producing antibiotics domestically.

On addressing the FDA’s flawed methodology in approving new opioids:  

“The questionable clinical trial practice known as enriched enrollment has made it significantly easier for the FDA to approve new opioids and allows for broad marketing to the public. These clinical trials also remove patients with pre-existing sensitivities to opioids, which has skewed results and seriously underestimates the risks associated with the proposed drug. Your Advisory Committee last year expressed concerns about if enriched enrollment is really able to address whether an opioid is better than a non-opioid and in September I sent you a letter asking for an update. We haven’t heard a thing back. So, what have you done in response to these concerns?” Senator Manchin questioned.

The FDA uses a clinical trial methodology known as “enriched enrollment randomized withdrawal” (EERW) to approve opioids. External reviews required by Senator Manchin’s FDA Review of Efficacy of EERW Double-Blinds (FREED) of Opioids Act, which passed out of Committee in December, as well as a report the FDA ordered itself have stated that they should “revisit the use” of EERW, citing several concerns in its effectiveness. However, this methodology is still in use.

On removing outdated opioids from the market:

“Opioids have been devastating to this entire country, especially in my state of West Virginia,” Senator Manchin said in part. “I can’t understand why you all continue to allow new opioid products to come onto the market. Your job is to make sure a new approval represents an improved product – if something is an improved product, don’t you think another one should then be removed from the market?”

Senator Manchin’s Protecting Americans from Dangerous Opioids Act, which he reintroduced this year, would require the FDA to remove one opioid medication currently on the market for every new opioid medication that they approve.

On increasing domestic production of antibiotics:

“Do we produce any antibiotics here in America?” Senator Manchin questioned. “Have we raised an alarm bell on this? Shouldn’t we have some manufacturers at least producing the basics for us?...We have American manufacturers who want to get back into business making antibiotics.”

A video of Senator Manchin’s questioning is available here.