Director, Office of Compliance, Center for Drug Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human Services
Silver Spring, Maryland
Through aggressive enforcement actions, incentives and multi-faceted education campaigns, is stopping the distribution of hundreds of unapproved prescription drugs.
Tackling a serious and long-standing public health problem, Deborah Autor of the Food and Drug Administration (FDA) has led an ongoing, multi-year initiative to remove hundreds of potentially dangerous prescription medicines from the market that were never approved for their safety or effectiveness as required by law.
As director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, Autor designed the program to identify the unapproved drugs, evaluated the public health consequences, explored the legal challenges, set up incentive, education and outreach programs, and initiated an aggressive enforcement effort.
As of spring 2010, the FDA had taken enforcement actions to remove more than 500 unapproved prescription drugs from the market, impacting more than 275 drug manufacturers and distributors. Autor estimates that unapproved medicines represent less than two percent of prescriptions filled every year. But, in the multibillion-dollar U.S. prescription drug market, this means that thousands of consumers are exposed to drugs that may be unsafe.
The targeted medications have included cough medicines, antihistamines, certain single-ingredient narcotics, analgesics for pain, anti-inflammatory drugs, migraine medicines, gastrointestinal pharmaceuticals and many other products, including some prescribed to children and some reportedly linked to deaths.
“The unapproved drugs on the market have been a problem for quite a long time,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Deb brought persistence and a laser-like focus to this goal, and conceived and executed a strategy. In doing so, she improved drug safety for the American public.”
Steven Galson, a former acting U.S. Surgeon General and longtime FDA official, said Autor developed the program under budget constraints, withstood scrutiny and criticism from some in the drug industry and Congress, successfully navigated the internal FDA process and took aggressive action to clamp down on the illegal drug marketers.
“She’s very balanced and calm, and she’s got very good people skills,” said Galson. “She’s technically very good. She knows how to analyze complex scientific information and translate it in a way that the public and Congress can understand.”
Many of these unapproved medications were on the market before Congress made successive changes to the drug approval process, including 1962 amendments that required that pharmaceuticals not only be safe but also effective. While most pre-1962 prescription remedies were later evaluated by the FDA, many claimed exemptions because they or similar drugs were marketed without FDA approval before the changes to the law.
Autor’s team found that most of the “grandfathered” drugs had been changed—their formulations, dosages, how they are administered, and for what patients and conditions they are recommended—making them “new” drugs requiring formal review and approval. Other unapproved drugs were not even grandfathered, yet manufacturers ignored the FDA approval requirement. The unapproved drugs have names and packaging that look just like approved drugs and they are even in the Physicians' Desk Reference.
For example, the FDA ordered a number of manufacturers to stop marketing unapproved drugs that contain quinine, which is often used to treat leg cramps. The agency said it has received 665 reports of serious adverse events associated with quinine use since 1969, including 93 deaths. Among the side effects of quinine are cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reaction.
Autor said she was “deeply concerned” that there were potentially dangerous drugs on the shelves that were routinely prescribed by doctors, dispensed by pharmacists and taken by patients.
“I knew this was important to do, and it was just getting worse over time,” said Autor of a problem that had gone unaddressed for decades.
Autor organized a one-day workshop in 2007 to educate 400 manufacturers and distributors of drug products on how to come into FDA compliance. She also educated medical providers through satellite radio segments, videos, podcasts and Web-based training.
“We’ve tried to be as proactive as we can and to get the word out,” said Autor.
Autor also said she and her team had to deal with a number of complications, including avoiding shortages for people who needed certain types of medications. Autor said this meant ensuring that there were alternative treatments available when unapproved drugs were taken off store shelves.
Jeffrey Kelman, a chief medical officer at the Centers for Medicare and Medicaid Services, said Autor was able to “think outside the box” and go the extra steps needed to bring this project to fruition. “It would have been impossible without her interest, energy and administrative experience,” said Kelman.
Autor said her passion for public health has fueled her work at FDA, and she credited the contributions of her compliance team that developed “a proactive culture of strategy and action.”
“We are finally tackling a long-lingering public health problem and we are making significant strides in protecting the health of the American public,” Autor said.