Lawmakers Question New FDA Leader on Opioids, Biosimilars

March 2 (BNA) — Opioid abuse and lack of biosimilar guidance continue to be pressing issues for the FDA, senators told the new head of the agency March 2.

Robert Califf appeared on Capitol Hill for the first time as the head of the FDA, testifying at a brief hearing on the FDA’s fiscal year 2017 budget request before the a Senate Appropriations subcommittee. The Senate confirmed Califf, who was already an agency official, on Feb. 24.

While food safety and tobacco issues were also discussed, lawmakers questioned Califf about when the FDA would issue final versions of all biosimilar guidance documents and what the agency is doing to combat the opioid abuse epidemic.

On biosimilars, Califf said the agency would “get out guidance soon” and is taking this seriously because there are currently 59 biosimilar products in the pipeline.

“If we don’t get this out soon, it’s going to be hard for people to navigate,” Califf said.

The Affordable Care Act created a pathway for the FDA to approve follow-on biologic drugs, or biosimilars. Thus far, the FDA has approved one biosimilar under that law. According to the FDA, a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product.


Sen. Jeff Merkley (D-Ore.), ranking member of the subcommittee, asked why the FDA hasn’t always used advisory committees before approving opioid drugs, which are used to control pain.

Concerns about FDA’s handling of opioid concerns slowed Califf’s nomination. Some senators, including Edward Markey (D-Mass.) and Joe Manchin III (D-W.Va.), objected to Califf’s nomination because they were critical of his role in what they said is a weak agency response to the opioid epidemic (10 LSLR 04, 2/19/16). Specifically, the lawmakers said they want the agency to reverse its approval of a pediatric use for OxyContin.

“We’re really taking a deep look at opioids,” Califf said. Opioid abuse “is a national epidemic” and “we’re changing our tactic on this” issue, he said.

Merkley specifically questioned Califf about why the FDA approved Zohydro in 2013 even though its advisory committee voted against approval and also asked why it approved OxyContin for pediatric use without first holding an advisory committee.

In August 2015, the FDA approved Purdue Pharma LP’s OxyContin (oxycodone) for use in pediatric patients 11 to 16 years old for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro is a pure hydrocodone painkiller manufactured by Zogenix Inc.

Califf said that while its true that the advisory committee voted against recommending approval of Zohydro, the committee did specify there were certain criteria “that might make it o.k.” He said the FDA did require certain conditions when it approved Zohydro and “ if we did it over again we would have met with the advisory panel again” so that they could vote on whether the conditions were sufficient.

When it comes to OxyContin for pediatric use, Califf said doctors could prescribe the drug for children before this approval. He said the FDA’s approval allowed the appropriate dosing for children to be put in the drug’s label. He said the agency “learned a lot” from seeing the public reaction to this case and the FDA plans to hold two consecutive advisory panels to examine its approaches to opioid use in children.

Califf also said opioid prescribing is out of control and there should be mandatory education for physicians about treating pain and how to prescribe opioids.

FDA’s High Priorities

Other areas that Califf said are a high priority for the agency include precision medicine, drug compounding and antimicrobial resistance.

Precision medicine refers to a medical model that accounts for differences in people’s genes, environment and lifestyle to determine optimal treatment for individual patients. In the area of compounding, the agency is implementing a 2013 law designed to address safety concerns about custom-made drugs.

Sen. Jerry Moran (R-Kan.), chairman of the subcommittee, said he is “concerned that FDA is often slow at communicating with us and our staff.”

“I do think FDA can do a better job of explaining what it’s doing,” Califf said. “We’re going to step up our communication.”

The hearing was cut short by a Senate vote, but Moran closed the hearing by saying he plans to invite Califf back for a more “in-depth conversation.”