The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > Senator Looks to Bypass FDA and Remove Zohydro With Legislation

Senator Looks to Bypass FDA and Remove Zohydro With Legislation

Posted 14 March 2014 | By Alexander Gaffney, RAC

A US senator is calling for the US Food and Drug Administration's (FDA) to ban a recently approved pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), not through a letter or request, but by legislation.


FDA approved Zohydro ER in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory committee meeting at which a majority of the committee members voted against approving the drug, citing its potential for abuse. The drug, unlike most hydrocodone-based products on the market, lacks abuse-deterrent characteristics, making it easier to abuse.

The drug, however, is indicated for those who experience severe pain and require around-the-clock treatment. Advocates for the drug have cited the need for a hydrocodone product without acetaminophen, which can cause toxicity in high doses. The product's manufacturer, Zogenix, said in a statement that the product would especially help patients avoid liver injury, which can be caused by high-dose long-term use of acetaminophen.

The drug's lack of abuse-deterrent qualities has made it a lightning rod for critics, who contend that its existence will exacerbate rates of drug abuse.

Among those critics are numerous US senators, who have launched a campaign against the drug notable for its steady escalation.

As Regulatory Focus has previously covered, Senate Minority Leader Mitch McConnell sent a letter to FDA in February 2014 demanding to know why the agency had approved Zohydro.

Several weeks later, Sens. Joe Manchin (D-WV) and David Vitter (R-LA) followed suit, accusing FDA of being improperly influenced by participation in a small invitation-only conference where some companies paid as much as $35,000 to attend. Those meetings, they said, may well have influenced FDA's decision to approve Zohydro and delay rescheduling hydrocodone as a Schedule II drug.

A Strategy of Regulatory Uncertainty

Then, in early March 2014, Sen. Charles Schumer (D-NY) launched a new strategy: Lobby the US Department of Health and Human Services (DHHS), FDA's parent agency, to overturn the Zohydro decision. DHHS has only once before in its entire history overturned an FDA decision, which occurred in 2011. A week later, Sen. Manchin signed on to that strategy, firing off his own letter to DHHS calling for the removal of Zohydro. 

As we wrote at the time, such a strategy is rife with potential long-term problems for the life science industry. If DHHS establishes a habit of overturning FDA based on political considerations, it will become increasingly difficult to develop products for controversial applications such as birth control or abortion. The strategy might also come to be used to overturn Complete Response Letters (CRLs) to companies, and perhaps even take long-marketed drugs off the market.

Could this strategy lead to a future in which FDA is no longer the expected last word on regulatory approvals?

Legislative Response

This week Manchin made another addition to a growing list of strategies intended to force the drug off the market: Legislation.

Manchin's bill, the Act to Ban Zohydro, specifically calls for "withdrawal of approval of drug Zohydro ER" no later than 45 days after the passage of the Act, and for FDA not to approve "any application under section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for pure hydrocodone bitartrate extended-release capsules" lacking abuse-deterrent qualities.

Regulatory Focus was unable to recall any recent legislation similarly targeted at a single drug product. Legislation introduced in 2003 would have banned RU-486, a drug sometimes used in abortion procedures, but the bill was never passed into law.

Manchin explained in a statement that the legislation was intended as a last-resort option to remove the drug from the market.

"I have tried reasoning with the FDA, and I've repeatedly requested the agency change its course on this dangerous drug," he wrote. "Their refusal to budge forces me to introduce legislation. Keeping Zohydro on the market is "the last thing we need," Manchin added.


Act to Ban Zohydro

Manchin Statement


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.