FDA’s Dr. Robert Califf on Changes in Drug Policy

By Patrick Reed | 9/13/16 8:00 AM

“There’s no question that the history of marketing opioids is a sinister part of American history that will be looked back upon very negatively.” –FDA Commissioner Robert Califf

One of the most important responsibilities in finding lasting solutions to the opioid abuse epidemic lies with those who regulate the highly addictive drugs at the core of this crisis.

The U.S.  Food and Drug Administration’s new action plan, unveiled last spring, focuses on reforming drug marketing, requiring drug companies to do more research on opioids’ long-term effects, and broadening access to overdose treatment.

KET’s Renee Shaw interviewed Dr. Robert Califf,  commissioner of the U.S. Food and Drug Administration,  on Connections about his agency’s response to the opioid addiction epidemic, which was introduced as an Action Plan earlier this year. Califf was at the Pikeville Medical Center as part of a listening tour.

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Opioids provide pain relief for patients suffering from serious illness and injury, but are also highly addictive. Starting in the mid-1990s, opioids became more widely prescribed for pain, and a drug abuse epidemic in Appalachia soon spread nationwide. More recently, the dissemination of new, synthetically modified opioids has led to a spike in overdoses that is causing health policy leaders to reassess their response to the epidemic.

Califf served as the FDA’s deputy commissioner of medical products and tobacco before being appointed commissioner in February. A cardiologist, Califf earned his medical degree at Duke University. He was a professor of medicine there and a vice chancellor for research before joining the FDA.

“There’s no question but that, over the last 10 to 15 years, there’s been too much opioid prescribing, and I think that almost everyone now is familiar with the history here,” Califf says. He explains that with roughly one-third of Americans suffering from significant pain each year, doctors grew too accustomed to opioids’ usefulness in eliminating short-term pain and began over-prescribing them for relatively minor injuries.

“The impact of too many pills in the environment is giving people who wouldn’t otherwise be exposed to them the opportunity to pilfer the pills out of the medicine cabinet,” he says. “All of this adds up to a huge epidemic of overdose and addiction.”

Rethinking Pain Management, Reforming Drug Marketing
Dr. Califf readily acknowledges that opioids are vital for patients suffering from severe pain, whether short term or chronic. His 88-year-old mother, who suffers from multiple myeloma, gave him permission to tell her story. The myeloma causes severe bone pain, so for her, opioids have been beneficial. “If you look at my mother I would say, ‘Thank goodness that we do have opioids on the market,’” Califf says.

“But that’s different than if you have a tooth extraction or a sprained ankle, or you’re an athlete with a shoulder injury,” he continues. For effective pain management, Califf says, “I think that it’s really a matter of the doctor-patient relationship and developing a strategy. And opioids should really not be the first thought, they should be considered when other things don’t work.”

Califf says that, as FDA commissioner, he is tasked with regulating drugs rather than medical practice, but as a physician he is fully behind the crackdown on unscrupulous doctors and “pill mills.”

“A big focus in the federal government now is on this issue of, not just opioid prescription, but asking ‘How do you treat pain in the most effective way?’” he says. “And I would just say that it hasn’t been a big enough focus of our medical schools, of our research organizations. We’ve got to pick up the pace across the board here.”

Califf feels strongly about the responsibility of the pharmaceutical industry to reform its marketing practices. “There’s no question that the history of marketing opioids is a sinister part of American history that will be looked back upon very negatively,”  he says.

Although the courts have protected drug companies’ rights to advertise under the First Amendment, Califf and the FDA are committed to using their authority to curtail excessive and misleading marketing practices. “We’re working right now internally to come up with our recommendations about corporate responsibility, but certainly the kind of marketing that went on in the past, convincing doctors to give high prescriptions to these medicines when they’re not indicated, it just was wrong, and we intend to try to stop it when we can,” he says.

“I would urge people, if you see bad advertising or bad promotion going on by a drug company, send us a note, and we’d like to take it on.”

A New Action Plan for Opioid Regulation
Reforming drug marketing is one part of the FDA’s new Action Plan. Another important reform requires drug companies to strengthen their research on opioids after they reach the market to gain a better understanding of their long-term consequences. As Califf notes, opioids have a broad social impact due to their diversion and abuse.

The FDA’s Action Plan also strengthens regulation of opioid labeling for children, which Califf calls “a very special issue. There are about 10,000 to 15,000 children a year who either have cancer, or in heavy trauma, they have multiple broken bones and are in the hospital, or have major deformities that require huge surgery, and we need special prescribing for them that is very closely watched. So we have a special advisory committee to help us deal with that.”

Other aspects of the Action Plan address the broader use of naloxone for overdose reversals, and the use of buprenorphine, or Suboxone, for addiction treatment. He calls the development of a buprenorphine transdermal patch, which is just reaching the market, a “big step forward” in that it enables doctors to control the amount of the drug that is released to a patient and thus better manage his or her recovery.

As for naloxone, Califf talks about a recent visit to Mingo County in West Virginia, near Pikeville, where he spent time with first responders, helping to educate them on how to administer the lifesaving overdose antidote. “There’s a critical need to educate law enforcement about this, because they are often the first people on the scene,” he says. “You don’t need an M.D. to give intra-nasal naloxone, and it could save a life.”

Califf says that the FDA’s Action Plan is in its early stages and will be refined, but he says that ultimately the opioid and heroin addiction crisis will be overcome only if stakeholders from all corners of society – government, nonprofit, faith-based, and families – work together. He is encouraged by the progress he’s seen in places like Pikeville.

“There’s always hope, that’s the nature of the human condition,” he says. “And I think we already see progress. We heard today that, in Kentucky, opiate prescriptions are down over 20 percent. Now, they’re having to fight a new problem which is more street drugs, which people are addicted to, but I think we already see signs that I think we can turn this thing around. It’s going to be a generational effort. It’s not a one-year, five-year, or 10-year effort.”

foundation_logo2013This KET article is part of the Inside Opioid Addiction initiative, funded in part by the Foundation for a Healthy Kentucky.