Budget Hearing Rebuffs Trump Bid to Hike FDA User Fees
House FDA budget lawmakers 5/25 dismissed the Trump Administration’s request (see earlier story) to renegotiate user fee agreements to increase the fees by $1.2 billion to offset budget authority decreases. Fresh on the job after two weeks, FDA commissioner Scott Gottlieb represented the agency at a House budget subcommittee hearing only to be told that the user fee proposal was practically dead on arrival. Rep. Rosa DeLauro (D-CT) told Gottlieb that the proposal is “quite frankly not going to happen.” Subcommittee chair Robert B. Aderholt (R-AL) added that “such efforts face a very steep uphill battle,” noting that current legislation to reauthorize the user fee programs is on the fast track to approval to avoid potential FDA staff layoffs that could begin as early as July.”
Gottlieb took the opportunity before subcommittee members to address a top priority for the Trump Administration — drug pricing. Recognizing that FDA does not play a direct role in pricing issues, Gottlieb did acknowledge that the agency can take steps “to facilitate entry of lower cost alternatives to the market and increased competition, and this is especially true when it comes to generic medicines.”
Toward these goals, Gottlieb continued, “we are working on a drug competition action plan that I will unveil soon. We believe FDA can be doing even more to improve our processes and communications with generic drug developers, both individually during the drug development process and through more helpful guidance documents. We believe better and more frequent dialog can make the generic review process more efficient, and make it easier for applicants to bring generic products to the market. At the same time, FDA also needs to take steps to make sure its regulatory processes are not being used inappropriately in ways that take advantage of patients.
“To these ends,” he continued, “we want to do three things: First, curtail gaming by industry of our regulations which can extend monopoly periods beyond the time frame Congress had intended, hindering competition. Second, improve the processes that enable generic versions of complex drugs to be approved. And finally, increase the overall efficiency of the generic drug review process while completely eliminating the backlog of generic applications, something that requires action on the part of both FDA and the generic drug industry.”
Gottlieb said FDA has an important role to play to make sure regulatory processes are not manipulated in ways the agency and Congress did not intend. He said an upcoming public meeting will “solicit input on situations where manipulation occurs so that we can assess the ways our regulatory processes may not properly balance innovation with competition as Congress has intended. For example, we know the processes related to REMS, which are intended to assure that certain drug products are used safely, are sometimes used in ways to slow generic competition. We are going to take steps to address this and to this end, we are evaluating ways to streamline the process FDA uses to determine whether to waive the requirement that generic applicants and brand company share a single system for assuring safe use. We are asking ‘can FDA waive this requirement more readily than we have in the past in situations where sponsors have not reached agreement after a reasonable period of time on implementation of a shared system.’”
Additionally, Gottleib said the agency will take steps to improve the overall efficiency of the generic drug review process to help increase product competition. “This includes additional guidance to reduce multiple cycles of review that generic drugs often undergo before their applications can be approved,” he said. “We also want to increase transparency in those cases where competition is absent by highlighting situations where off patent drugs lack approved generic competitors. We believe greater transparency in these circumstances can help entice competitors into the market... We will publish a list of these and update it regularly. We will consider whether we can provide further transparency by disclosing additional information to help generic manufacturers target drugs with little or no market competition.”
Asked to name FDA’s other top priorities, Gottlieb said he and the agency will “focus very hard on addressing opioid addiction, ... and also looking at places where we can facilitate more innovation by looking at regulatory rules that we create and making sure they are efficient, science-based, modern and up to date. Will look to the 21st Century Cures Act as a touchstone and as a strategic plan to help guide our implementation of policies that can help facilitate innovation.”