The US Food and Drug Administration (FDA) on Thursday, May 17, listed drugmakers, including Celgene, Johnson & Johnson, Gilead Sciences and Novartis, which the regulator claims are potentially blocking access to samples of their drugs to delay generic competition.
Generic drugmakers may not be able to develop alternatives without access to samples of branded products they intend to copy, the FDA said.
“I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” FDA Commissioner Scott Gottlieb said in a statement.
The companies with the most complaints include Celgene, Gilead Sciences, Johnson & Johnson’s Actelion and Novartis. Generic-drug companies requested FDA assistance in receiving samples of a variety of drugs from those companies, including cancer, HIV and rare disease drugs.
“We know that certain brand-name manufacturers are abusing the system by blocking access to samples and hiding behind FDA’s rules when they do it,” Health and Human Services Secretary Alex Azar said in a Monday speech about the administration’s drug price plan. “FDA is going to begin publicly identifying drug companies suspected of engaging in these abusive practices.”
FDA Commissioner Scott Gottlieb has said brand-name drug companies’ “shenanigans” to stall competition must stop.
Full Content: The Wall Street Journal