The previous year has been deemed as the deadliest year in American history because of COVID-19. But aside from that, it was also a dangerous year for substance abuse. The U.S. has been fighting the consequences of the opioid crisis even before 2020, with many states suffering losses due to drugs like fentanyl, heroin, and other prescription medications.
The ongoing fight against the opioid crisis has given courage to people who have suffered from the effects of the medications to file their claims in the Opioid Epidemic Lawsuit. The legal proceedings have been seeing a growing number of plaintiffs who want to seek relief from the effects of the highly addictive medication not only to them, but also to their family.
With the latest transition to a new administration, everyone is looking forward to what Biden can do for America’s health care, which is one of the top deciding factors in the previous US elections. But the day Biden took office, a controversial official was named acting FDA commissioner, and the announcement caused uproar among advocacy groups that continuously fight the US opioid epidemic.
A Letter to President Biden
Advocacy groups have urged Biden to look for another official to serve as the head of the Food and Drug Administration (FDA) after saying that the acting commissioner is not an ideal person for the post because of her role in the mass prescribing of painkillers that has caused the loss of hundreds of thousands of lives.
In a letter written to the administration, 28 advocacy groups fighting the opioid epidemic said Dr. Janet Woodcock served as head of the Center for Drug Evaluation and Research (CDER), an FDA department which, during her term, approved new prescription opioids. The time period was called by the groups as “one of the worst regulatory agency failures in US history.”
In the letter, the groups urged Biden not to nominate her to permanently lead the agency.
“In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of the opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter read.
The letter also claimed that Woodcock is guilty of “dereliction of duty” for not doing anything against opioid manufacturers who disseminated false claims and marketed narcotic painkillers as less addictive and more effective than they actually were. This ended up contributing to mass opioid prescribing and a widespread epidemic that has claimed more than 500,000 lives, and the numbers continue to rise as the pandemic persists.
Groups who were signatories of the letter include the consumer advocacy organization Public Citizen, medical group Physicians for Responsible Opioid Prescribing, and campaign groups representing families affected by opioids like Fed Up!.
The letter added, “Recent reports that the pharmaceutical industry enthusiastically supports Dr. Woodcock’s candidacy for FDA commissioner do not surprise us.”
“We strongly urge that her position as Acting Commissioner be a very short transition prior to President Joe Biden nominating a Commissioner who has a track record focused on public health,” the letter said.
The FDA and its Tarnished Record
The FDA had a role in unleashing the epidemic two decades ago when it approved OxyContin, a highly addictive narcotic pill, for sale, after it was falsely marketed by its manufacturer, Purdue Pharma, as more effective and safer than other painkillers.
Since then, the agency has continued approving other opioids for prescribing even as there’s evidence that the medications were addictive and open to substance abuse. This gave rise to the accusations that the agency is less interested in regulating opioid manufacturers than backing their financial interests.
In 2017, President Trump’s opioid commission called the failure of the FDA and other institutions in handling opioids as factors that led to the rise of the epidemic.
The letter added that Woodcock played a significant part in the approval of Zohydro, a powerful opioid, when she made use of her authority to override the advisory committees’ decisions, who voted 11-2 in keeping the drug off the shelves because it was unsafe.
Dr. Raeford Brown, former chair to FDA’s opioid advisory committee, described Dr. Woodcock as a very able administrator, but he admitted that her role in unleashing prescription opioids into America made her unfit to be an FDA head.
“They didn’t want to see that the things they were doing were causing the problem. She was in charge of that. She more than anybody should be held accountable. I’m shocked she hasn’t been held accountable,” Brown said.
As of writing, it is not clear whether Biden plans on nominating Dr. Janet Woodcock to lead the FDA permanently.