Regulatory Focus™ > News Articles > Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

Posted 05 March 2014 | By Alexander Gaffney, RAC

Under normal regulatory procedures in the US, when a new drug is approved by the US Food and Drug Administration (FDA), its approval decision is the last word. But now in the wake of the agency's approval of a painkiller that critics say is dangerous, one senator is calling for US health officials to exercise a rarely used authority to overturn the decision.

Background: Plan B

Until December 2011, FDA had never before seen one of its decisions overturned. But shortly after voting to make Teva Women's Health's Plan B One-Step available to women under the age of 17 on an over-the-counter basis, the Department of Health and Human Services (DHHS)-and some say politics-stepped in.

On 7 December 2011, DHHS Secretary Kathleen Sebelius overruled FDA, saying the decision lacked the necessary data to show the drug would be safe for use in its youngest potential users.

"After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age," Sebelius wrote, saying more data was needed to prove the drug's safety in girls as young as 11.

"I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women's Health, Inc," she concluded.

Background: Critical Reaction

FDA, including Commissioner Margaret Hamburg, reacted with thinly veiled fury.

"It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence," Hamburg wrote in a statement, adding that the review of the drug reflected a scientific process and the views of a wide range of stakeholders. Hamburg had personally reviewed the approval decision, she said, and had agreed with it.

Other officials, such as Judge Edward Korman of NY's Circuit Court, outright slammed Sebelius. Her directive had "forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability," Korman said in a statement. In addition, the decision was characterized by Korman as a "significant departure from agency practice."

Former FDA officials were also vocal in their criticism of the decision.

"Secretary Sebelius has opened the door to political reversals of FDA scientific and medical decision-making, and once you open the door there's no way to close it," said Mary Pendergast, a former FDA associate commissioner under President George W. Bush, in an appearance on BioCenturyTV. "I expect to see a lot of additional interventions in FDA decisions going forward."

Another former FDA associate commissioner, Peter Pitts, said that the decision would likely create an incentive for companies and others to directly lobby the secretary regarding various approval decisions. This, he said, could further complicate the regulatory process and subject it to more political interference.

Precedent Returns

Pitts, it would seem, was exactly right.

This week, Sen. Charles Schumer (D-NY) called on Sebelius to again overturn yet another controversial FDA decision, this time regarding a painkiller known as Zohydro.

The controversial drug, approved by FDA on 25 October 2013, is an extended released capsule composed of pure hydrocodone and intended for around-the-clock treatment of those in severe pain. Unlike other painkillers in its class, it lacks two characteristics: The presence of acetaminophen, and any abuse-deterrent qualities.

It is the latter of those two qualities that have spookedlegislators, who fear that the drug may soon fuel an epidemic of painkiller abuse.

But until now, those legislators have simply called for FDA to explain its action. Schumer, chairman of the powerful Committee on Rules and Administration and a member of the Finance and Judiciary Committees, is taking a different route entirely.

In a statement, he said he had called on DHHS to "overturn" what he called "a disastrous decision by FDA."

"It is inexcusable that a product with more potency and without abuse deterrent technologies has been approved for production," Schumer wrote in a letter to Sebelius.

"I urge you to override the FDA's approval of Zohydro ER and work quickly to stop it from being sold to consumers," he concluded. "It is essential that we stop yet another dangerous drug from playing a role in our country's national drug epidemic, and that we also begin to incorporate abuse-deterrent technologies into all dangerous opioids as new drugs are introduced to the market."

The drug is slated to go on sale in March 2014.


Schumer Letter

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