FDA commissioner outlines 3 focus areas for improving generics competition

WASHINGTON — Food and Drug Commissioner Dr. Scott Gottlieb laid out a preliminary vision of his plans to bring more generics to market at a hearing before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies on May 25. The hearing was held as part of several others that sought input from administration officials about President Donald Trump’s proposed budget.

Gottlieb, there to discuss the proposed 10% increase in funding over the fiscal year 2017 continuing resolution’s FDA funding level, dedicated his opening statement entirely to the questions of innovation and access to generics.

“Simply put, too many patients are priced out of the medications they need,” he said. “While the FDA does not play a direct role in drug pricing we can take steps to facilitate entry for lower cost alternatives to the market and increase competition. This is especially true when it comes to safe and effective generic medicines.”

Gottlieb said that in order to address these goals, he would be outlining in the future a plan for facilitating more generics competition. He said the agency’s focus would be on three goals — cutting down on companies gaming regulations, which he said can prolong a drug’s monopoly period; improving the processes around approving a generic; increase the overall efficiency of the drug review process while working to eliminate backlogged applications.

“FDA has an important role to play in preserving the balance between innovation and access and making sure that its' statutory and regulatory processes are working as intended and not being manipulated in ways that the FDA and Congress didn’t intend.”

With regard to abuse of Risk Evaluation and Management Strategies, companies making a branded drug will be hesitant to use REMS as a way to prevent a generics maker from acquiring samples, Gottlieb said. He added that he would soon announce a public meeting to solicit public input on where the regulatory process is being misused.