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Regulatory Focus™ > News Articles > Pressure Mounts on FDA to Reconsider Approval of New Painkiller

Pressure Mounts on FDA to Reconsider Approval of New Painkiller

Posted 20 March 2014 | By Alexander Gaffney, RAC

A group of legislators in the House of Representatives have become the latest group to introduce legislation that would seek to specifically ban a new hydrocodone painkiller recently approved by the US Food and Drug Administration (FDA)-an action some critics say would undermine the regulator's authority and set a dangerous new precedent.


FDA approved Zohydro ER (hydrocodone bitartrate) 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.

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.

Legislators Demand Action

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.

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. 

Legislation as a New Strategy

A week later, Manchin unveiled yet another strategy, this time based not on advocacy, but 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.

Now that strategy has received some significant support in the House of Representatives.

On 13 March 2014, a bipartisan group of 13 House legislators introduced identical companion legislation-also known as the Act to Ban Zohydro-intended to force the drug off the market within 45 days and to prevent future non-abuse-deterrent versions of the drug from reaching the market.

The bill's primary co-sponsors, Reps. Stephen Lynch (D-MA) and Hal Rogers (R-KY), said in a statement that the drug's public health ramifications were too daunting to ignore.

"Allowing access to a drug so powerful, without this critical component, creates risks for the public drug we simply cannot afford," Lynch said in the statement. "[T]his is a giant step backwards at a critical time when prescription drug abuse has fast become a rampant problem across the nation. We cannot afford to allow yet another highly addictive opioid into the mainstream and potentially onto Main Street America."

Rogers said the decision, in light of other FDA actions to restrict access to hydrocodone, sent "mixed signals to drug companies about the need to invest in abuse deterrent technologies."

Dangerous Precedence for FDA?

But while access to the drug remains a point of heated debate, some in industry have questioned whether legislation to ban a specific FDA-approved drug could create more problems in the long term than it would solve.

As Focus wrote in March 2014, the strategy could result in a problematic precedent for FDA. If every controversial drug approval made by FDA can result in legislators simply overturning a decision, that could result in significant regulatory uncertainty for companies seeking to bring a product to market.

This is especially evident for companies developing birth control products, painkillers and products intended to be used in abortions.

And, as we noted, this strategy could also be used to overturn Complete Response Letters (letters indicating a drug has been rejected) to companies or even take long-marketed drugs off the market.

This line of thought was mirrored by former FDA Associate Commissioner Peter Pitts, who wrote last week that "FDA must take the lead" on drug approvals-not Congress.

"Whatever your position on the issue of opioids, the proper venue for this decision is not the office of the Secretary of HHS or the halls of Congress or the courts -- but rather the office of the FDA Commissioner," he concluded.


Act to Ban Zohydro

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