Scholarship by Patricia J. Zettler, a College of Law faculty member under Georgia State’s Second Century Initiative, and her colleagues was recently covered in The Regulatory Review, where they contend that the FDA’s current regulatory approval process is insufficient in looking at the safety and efficacy of drugs like opioids.
The publication writes:
Recently, several health law scholars have argued that the U.S. Food and Drug Administration(FDA) is partly responsible for the nationwide opioid epidemic. They claim that FDA’s current regulatory oversight process for high-risk drugs like opioids fails to take into account sufficient information about their safety and efficacy.
FDA’s current regulatory approval process narrowly focuses on clinical trial data to evaluate the health impact of drugs, overlooking broader public health effects such as those created by opioid addiction, according to a recent paper by Patricia J. Zettler, Margaret Foster Riley, and Aaron S. Kesselheim. The federal agency should instead turn more consistently and frequently to broader sources of data—such as studies on population health impacts of high-risk drugs—when it decides whether to approve drugs or withdraw them from the market, argue Zettler and her coauthors.
Drug manufacturers typically resort to tightly controlled clinical trials to prove—through the use of “substantial evidence”—that their products have benefits that outweigh risks, which is a requirement under current FDA regulations, say Zettler and her coauthors.
But the particular sample of individuals included in a clinical trial often does not represent the population that ends up using the drug, assert Zettler and her coauthors. Indeed, researchers have an incentive to keep human variability to a minimum when selecting a sample of patients for a clinical trial. For this reason, they will study the effect of a drug on one population subset—people with lower back pain, for example—and disregard others, even if studying multiple subsets would paint a better picture of how patients react to the tested drug.
The article in The Regulatory Review is available at https://www.theregreview.org/2019/01/24/barsky-fda-drug-review-opioid-epidemic/. The paper by Zettler and her colleagues, published in the Food and Drug Law Journal, is available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3193096.
Learn more about Zettler and her work at https://nextgen.gsu.edu/2018/06/26/2ci-qa-patricia-j-zettler/.