In December 2006, Scott Gottlieb did something unusual for a deputy commissioner of the Food and Drug Administration: He joined other FDA officials who tried to help a pharmaceutical company secure more fentanyl for a powerful painkiller product.
The company, Cephalon, was running short of the opioid it put in a lollipop designed for the intense pain of some cancer patients, according to interviews and documents obtained by The Washington Post. But Cephalon was also under investigation at the time for illegally pushing doctors to prescribe the drug for other uses, from headaches to back pain.
Gottlieb is the Trump administration’s nominee to head the FDA. While his exact role in the episode is in dispute, his critics contend that his participation demonstrates the kind of friendly relationship with the pharmaceutical industry that they fear he will create at the FDA if he is confirmed.
“When the prescription opioid epidemic was exploding, it appears Dr. Gottlieb advocated to put even more addictive fentanyl onto the market when it wasn’t appropriate or necessary,” said Sen. Edward J. Markey (D-Mass.), who has previously criticized Gottlieb’s ties to the drug industry. “We cannot have a leader at the FDA who has aided and abetted the prescription drug and heroin epidemic by pushing more addictive, deadly opioids onto the American public.” Markey’s office has asked the Drug Enforcement Administration for documents related to the episode, in which Cephalon’s request was ultimately rejected.
Gottlieb declined to comment, citing the long-standing tradition of staying silent before a Senate committee vote on his nomination, which is scheduled for Wednesday. But Sheldon Bradshaw, a former FDA attorney, said Gottlieb’s role was minimal — confined to a meeting of FDA and DEA officials on Dec. 8, 2006, and only because protocol called for a deputy commissioner to be present given the participation of similarly high-level DEA representatives. In any event, Bradshaw added, Gottlieb’s responsibility was to help the FDA protect legitimate pain patients from possible shortages of critical analgesics.
“The FDA isn’t there to shill on behalf of Cephalon. They’re there to inform the DEA what the medical needs are,” he said.
The FDA itself had opened an investigation of Cephalon, but it is unclear whether Gottlieb or the other officials were aware of it at the time they met with the DEA. The month before the meeting, reports of a probe by the Connecticut attorney general had surfaced in the Wall Street Journal.
Gottlieb has said he will recuse himself from agency decisions for a year involving more than 20 companies he has worked for, invested in or had some other kind of financial relationship with, according to his federal ethics filings. That includes two big pharmaceutical firms, GlaxoSmithKline and Bristol-Myers Squibb. He also has said he would resign as a member of Glaxo’s product investment board.
There is no evidence in Gottlieb’s financial disclosure statements that he has accepted any payments from Cephalon, which was acquired in 2011 by Teva Pharmaceuticals. The company did not respond to requests for comment.
In a document submitted to a Senate committee as part of the confirmation process and obtained by The Post, Gottlieb wrote that “none of my actions were undertaken on behalf of, or intended to benefit, a particular person or company. Rather, my role was to represent the agency’s public health positions.”
Gottlieb called publicly in 2012 for the DEA to relinquish its control over the manufacture of drugs that contain controlled substances and transfer that authority to the Department of Health and Human Services.
Cephalon pleaded guilty in 2008 to illegally promoting the fentanyl lollipops — marketed under the name Actiq — and two other drugs, and paid a $425 million fine. The Justice Department said the company instructed its large sales force to focus on physicians other than oncologists and to promote Actiq for a wide variety of pain despite the restrictions imposed by the FDA.
According to court papers in a related case, just 1 percent of the prescriptions filled for Actiq in the first six months of 2006 were written by cancer doctors. The company’s revenue from the drug soared in just a few years.
“Whoever is in charge of the FDA must put the people’s safety over drug company profits,” said Sen. Sherrod Brown (D-Ohio), who has joined Markey in criticizing Gottlieb.
Since long before the opioid crisis mushroomed into the epidemic it is now, the FDA and the DEA have fought over whether the public needs more narcotics. (The fentanyl responsible for a surge in overdose deaths in the past few years is almost entirely a synthetic black-market version, not the drug produced for medical use.)
The DEA controls the annual “quota” of drugs containing controlled substances that are produced in the United States each year, and it assigns each manufacturer a certain portion of that allotment.
The 2006 fight between the two agencies over a possible shortage festered for months. Cephalon told FDA that it was running low on fentanyl because it was trying to produce its own branded Actiq as well as supplying two generic companies with versions of the lollipop, according to a letter from Steven Galson, then director of FDA’s Center for Drug Evaluation and Research, which monitors the U.S. drug supply. And the company had to destroy a sizable quantity of the painkiller because of a manufacturing problem, it said.
The FDA agreed. “This will result in a shortage which is anticipated to last approximately 10 weeks,” Galson wrote in a letter to a DEA official obtained by The Post.
The DEA was not convinced. The agency also met with Cephalon and said the public faced no shortage of the painkiller, because Cephalon had enough on hand and the two generic companies had more, according to a letter from then-Deputy Administrator Michele Leonhart to the FDA. It warned the FDA not to declare a shortage of Actiq or to suggest the use of another Cephalon fentanyl product, Fentora.
The episode was curious for another reason. The meeting came little more than three weeks before the start of 2007, when Cephalon would gain access to its full fentanyl quota for the next calendar year. Leonhart said she had difficulty understanding why Cephalon needed more fentanyl with so little time remaining until 2007.
“We find no basis to conclude that Cephalon must be given additional quota to use over the remaining 18 days of 2006,” she wrote.
Alice Crites contributed to this report.