FDA s Janet Woodcock failed to stop the opioid epidemic
Drug manufacturers such as Purdue might have ignited the deadly opioid crisis. However, the FDA was instrumental in allowing the epidemic to play out.
Gerald Posner
Opinion contributor
When the Biden administration tapped Janet Woodcock as the acting commissioner of the Food and Drug Administration, it seemed a good pick. Woodcock had spent 23 years as chief of the Center for Drug Evaluation and Research, a unit the FDA describes as its “consumer watchdog in America’s health care system. The CEDR is tasked with making certain that drugs are “safe and effective,” and “that the health benefits outweigh known risks.”
An FDA document related to CBD that had been pending for several months before the White House has been withdrawn, consistent with a freeze on regulations and guidance documents issued by the administration of President Joe Biden.
While stakeholders had not seen the actual document “Cannabidiol Enforcement Policy; Draft Guidance for Industry” pending before the White House’s Office of Management and Budget (OMB) since July, many were hopeful that publication of the guidance would help provide some measure of certainty to an industry operating for years in a state of regulatory limbo at the national level.
Withdrawal of the policy highlights “two years have passed since the 2018 Farm Bill made CBD legal, and FDA has made no meaningful progress on a clear regulatory path for CBD consumer products,” said Duffy MacKay, senior vice president of scientific and regulatory affairs with San Diego-based CV Sciences Inc., a marketer of hemp-based CBD products, in an email. “In my
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Dr. Stephen M. Hahn, who became commissioner of the Food and Drug Administration just weeks before the coronavirus pandemic began, resigned Wednesday as the administration of President Joe Biden began.