FDA issues two new policies to stop drug makers from blocking generics
Brand drug manufacturers are delaying the development and entry of generics, federal officials say.
Food and Drug Administration Commissioner Scott Gottlieb, MD, has released new policies to crack down on brand drug manufacturers that try to block the entry of generic drugs to the market.
Brand drugmakers are using FDA Risk Evaluation and Mitigation Strategy (REMS) requirements to block timely generic entry, Gottlieb said. The REMS are required from manufacturers to ensure that the benefit of a drug outweighs its risks.
"We have seen REMS requirements be exploited in two ways," Gottlieb said.
At the front end of the drug development process, some brand drug makers restrict the sale of their drugs, keeping them out of the hands of generic firms that typically need up to 5,000 doses to run the necessary bioequivalence and bioavailability studies.
On the back end of the process when the generic drug needs FDA approval, there is a often a long delay in the negotiations between the generic drug maker and the brand firm to enter into a shared REMS program. This requirement applies when a generic drug applicant wants to market a generic version of a drug that has REMS known as "Elements to Assure Safe Use," or ETASU.
"This is the impediment we're seeking to address today, with the new policies that we're announcing," Gottlieb said. "While the FDA recognizes that these negotiations are an important step in the formation of a shared system REMS … the REMS shouldn't become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market."
The first draft guidance being issued is the Development of a Shared System REMS, which is aimed at improving the clarity and efficiency for developing shared system REMS.
The second draft guidance, Waivers of the Single, Shared System REMS Requirement, allows generic applicants to request a waiver and use a different, comparable aspect of the ETASU.
While the current system enables market-based rewards for innovation, giving brand name manufacturers the incentive to take the risk and invest the capital to develop new medical advances, this must be balanced by the law which allows for brisk competition once the patent has lapsed, according to Gottlieb.
"Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by Congress that seeks to balance access with innovation," Gottlieb said.
Health and Human Services Secretary Alex Azar said greater competition is a key piece in the administration's plan to bring down drug prices.
Prescription drug prices are often cited as the top reason for the high cost of healthcare.
"HHS is taking more action on President Trump's blueprint to put American patients first," Azar said. "The FDA's announcement today will help generic drug manufacturers bring low-cost competition to market faster and discourage brand-name companies' misuse of laws meant to protect public health."
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
