FDA chief outlines Drug Competition Action Plan for generics
SILVER SPRING, Md. — Food and Drug Administration commissioner Dr. Scott Gottlieb has taken to the agency’s FDA Voice blog to outline the efforts he’s undertaking that are aimed at increasing competition in the generics market. The FDA’s Drug Competition Action Plan begins with a public hearing on July 18 to assess the places where FDA regulations could be creating obstacles to generic access.
“Innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health,” Gottlieb wrote. “We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused.”
Among the examples of potential gaming of the system Gottlieb outlined was making branded products unavailable for comparative testing. Among the methods he said limit generic companies’ access to the originator drug to study is restricting commercial contracts with distributors to make it difficult for intermediaries to sell to generics developers. He also pointed to the difficulty some companies have in accessing medications under limited distribution — either voluntary or through a Risk Evaluation and Mitigation Strategy.
Additional potentially limiting efforts, Gottlieb said, include using the legal requirement to have a single shared REMS across branded and generic versions of a drug as a way to block generic entry, as well as prolonging negotiations with generics makers over the single shared system.
I want to take steps to address these concerns, to make sure that we are facilitating appropriate competition in circumstances where Congress intended,” Gottlieb said. “As we solicit additional information, we also are going to be looking at policy and programmatic changes to address these issues. Some of these steps may be actions we can take by using our own authorities more forcefully. Other steps might involve our need to collaborate with sister agencies.”
He mentioned the FDA would be looking to work more closely with the Federal Trade Commission to figure out practices that could be limiting competition. Gottlieb also promised further updates on the Action Plan in the future and highlighted the July hearing’s role as a forum for identifying which existing rules don’t have their intended effect or fall short.
“Over the past five years our generic drug program staff has evolved and grown remarkably, while implementing the first generic drug user fee program. The staff has demonstrated that they can rise to new challenges and they have my full support,” he said. “I want the policy framework they operate under to be as efficient, fair, and robust as the review program that they’re operating.”
“Innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health,” Gottlieb wrote. “We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused.”
Among the examples of potential gaming of the system Gottlieb outlined was making branded products unavailable for comparative testing. Among the methods he said limit generic companies’ access to the originator drug to study is restricting commercial contracts with distributors to make it difficult for intermediaries to sell to generics developers. He also pointed to the difficulty some companies have in accessing medications under limited distribution — either voluntary or through a Risk Evaluation and Mitigation Strategy.
Additional potentially limiting efforts, Gottlieb said, include using the legal requirement to have a single shared REMS across branded and generic versions of a drug as a way to block generic entry, as well as prolonging negotiations with generics makers over the single shared system.
I want to take steps to address these concerns, to make sure that we are facilitating appropriate competition in circumstances where Congress intended,” Gottlieb said. “As we solicit additional information, we also are going to be looking at policy and programmatic changes to address these issues. Some of these steps may be actions we can take by using our own authorities more forcefully. Other steps might involve our need to collaborate with sister agencies.”
He mentioned the FDA would be looking to work more closely with the Federal Trade Commission to figure out practices that could be limiting competition. Gottlieb also promised further updates on the Action Plan in the future and highlighted the July hearing’s role as a forum for identifying which existing rules don’t have their intended effect or fall short.
“Over the past five years our generic drug program staff has evolved and grown remarkably, while implementing the first generic drug user fee program. The staff has demonstrated that they can rise to new challenges and they have my full support,” he said. “I want the policy framework they operate under to be as efficient, fair, and robust as the review program that they’re operating.”