Associate professor Patricia J. Zettler was quoted in an August 7 article in the Washington Post, “FDA barred from restricting company’s promotion of fish oil drug.” Amarin Corp, a pharmaceutical company, filed suit against the Food and Drug Administration stating that their marketing of their drug Vascepa for off-label use is protected under the First Amendment. The US District Court granted preliminary relief – the company may continue to market the off-label use while the lawsuit continues. Although doctors are allowed to prescribe medication for an off-label use, currently pharmaceutical companies must receive FDA approval before marketing the drugs for other uses. In the article, Zettler describes that this case has the potential to have significant impact on the FDA’s authority to regulate approved drugs.
Patricia J. Zettler is an associate professor at Georgia State University College of Law this fall and was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.