FDA Mandates Need Accompanying Resources, Hamburg Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The mandates in the FDA Safety and Innovation Act and Drug Quality and Security Act show a lot of congressional confidence in the agency, but FDA commissioner says that members also must provide resources to go with it.
Commissioner Margaret Hamburg reminded Congress that additional mandates require resources to go with them.
Congress has shown its confidence in FDA with legislation like the recently enacted Drug Quality and Security Act expanding regulation of compounding and drug shipment tracking. But Hamburg said that confidence must translate into more funding.
“I’m hopeful that along with this recognition, Congress will also provide us with the kind of real resources, not just new mandates and authorities, that are equal to the challenge,” she said Dec. 12 during the FDA-CMS Summit for Biopharma Executives.
Hamburg also said FDA remains an important part of research and development system and must be supported as such.
“It’s vital to invest continually in science as an engine of innovation and I hope that Congress hears that call,” she said. “But it’s just as critical that we maintain support for those processes and structures such as FDA, which contribute significantly to the meaningful translation of opportunities and discoveries in science into the real-world products that people are so counting on.”
Not coincidentally, Hamburg’s comments came as the House was nearing passage of a deal reached by the House and Senate Joint Budget Committee.
The deal includes a top-line spending levels that appropriators will use to determine the FDA and other federal agency budgets. It also gives relief from the mandated budget cuts caused by the sequester and allows the agency to spend all future user fees received at least through September 2015.
An FDA spokesperson said the agency had no comment on the budget deal.
FDA lost $209 million in fiscal year 2013 when the sequester took effect, including $85 million in user fees (Also see "Budget Accord Should Increase FDA Funding, Free Up User Fees" - Medtech Insight, 12 Dec, 2013.).
It is unclear whether the agency will regain the sequestered fee revenue (Also see "FDA’s Sequestered User Fees From FY 2013 Likely Gone, But FY 2014 Fees Could Be Exempted" - Pink Sheet, 5 Jun, 2013.).
The budget deal is an attempt to end the recent practice of using continuing resolutions to keep the government running.
Hamburg said recently that FDA needs budget predictability to run the agency effectively (Also see "Hamburg, Like Industry, Wants Predictability – But In FDA Funding" - Pink Sheet, 5 Nov, 2013.).
Regulatory Science Reminder
Hamburg’s speech harkened back to a desire to improve regulatory science, one of Hamburg’s major initiatives since taking over FDA. She has said a number of times that the agency must improve its tools to review and approve new drugs so it can more easily deal with cutting-edge products.
Hamburg said without the necessary funding the agency is in danger of not being able “provide and sustain the systems and capacity required” to review applications and ensure compliance with its regulations and “enhance collaboration in the ways that are so vitally needed.”
New product reviews could slow if the agency is unable to unfamiliar with new technology and requires outside help.
When asked whether the agency is able to keep up with innovation right now, the spokesperson said FDA is working with what it has.
Regulatory science improvements were among the provisions of the 2012 prescription drug user fee reauthorization (Also see "PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers" - Pink Sheet, 2 May, 2011.).
Pazdur Says Travel Cuts Hurting His Staff
Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said sequester-forced travel cuts are limiting his staff’s ability to learn about scientific advances as they are translated into new therapies.
During a session at the conference, Pazdur said reviewers cannot bring new development techniques into the agency if they cannot discuss them with the scientific community.
“It just is incomprehensible to me that we have these travel restrictions while we have this explosion of knowledge and discovery,” he said. “If the agency is truly going to be a partner … it really needs to be a participant in these scientific meetings.”
Travel restrictions meant only a handful of the staff in the oncology division could attend the major oncology and hematology scientific meetings this year. Senior staff also could not travel as much as previous years (Also see "Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too" - Pink Sheet, 16 Sep, 2013.).