From
The Washington Post:
Tackling a serious and long-standing public health problem, Deborah Autor of the Food and Drug Administration (FDA) leads 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 FDA's drug compliance office, 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.
The FDA so far has 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 many 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.
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.