Congress Mulls Adding “Economic Growth” To FDA Mission Statement

As PDUFA hearings start, Commissioner Hamburg says considering the jobs affected by the approval or denial of an application would be difficult and inappropriate. Rep. Rogers and Sen. Coats author bills to require changing FDA’s mission statement in program renewal.

Members of Congress propose changing FDA’s mission statement to include promoting job creation and economic growth as part of reauthorizing the Prescription Drug User Fee Act, a requirement the agency opposes.

The efficiency of FDA’s operations for the next five years depends somewhat on how effectively the agency engages with lawmakers as Congress produces legislation for PDUFA V. The unofficial deadline for PDUFA renewal is June, though the program does not expire until the end of September.

The gauntlet was thrown down Feb. 1 during the House Energy and Commerce Health Subcommittee’s first PDUFA hearing of 2012. The hearing’s topics included the Food and Drug Administration Mission Reform Act of 2011, H.R. 3214, that subcommittee member Mike Rogers, R-Mich., introduced in October.

H.R. 3214 and a matching bill , S. 1972, Sen. Dan Coats, R-Ind., introduced in December, would update the agency’s mission, in part, to state FDA should protect public health and enable patient access to novel products “while promoting economic growth, innovation, competitiveness and job creation among the industries regulated.”

Discussion during the hearing about editing the mission statement began when Rep. Frank Pallone, D-N.J., the subcommittee ranking member, said FDA could force jobs and innovation offshore by requiring too much data in applications.

But Pallone said changing the mission statement seemed like a “drastic measure.”

Commissioner Margaret Hamburg steadfastly opposed the idea. Hamburg indicated job-creation directives could put FDA in an awkward position and would be difficult to quantify in approval decisions.

“It is going to be very hard for us to factor into this science-based decision-making the question of how does approving or not approving a product impact jobs and how would approving or not approving a product impact [the] jobs of a competitor,” she said.

“It would get very, very complicated and, frankly, I think it would be quite inappropriate and would ultimately not serve the American people well or serve industry well.”

Coats’ S. 1972 was referred to the Senate Health, Education, Labor and Pensions Committee, which has not scheduled a hearing on the bill.

BIO Suggests Amending FDA Mission

FDA’s mission currently is to promote public health by promptly and efficiently reviewing research and acting on the marketing of regulated products in a timely manner, in part by assuring human drugs are safe and effective, according to the Food, Drug and Cosmetic Act.

The mission also states FDA should work with other governments to harmonize requirements and reduce the burden of regulation.

Changing the mission statement to include innovation was among the “big ideas” the Biotechnology Industry Organization presented last year in its report “Unleashing the Promise of Biotechnology.” BIO said the agency should update its mission to “incorporate modern scientific tools, standards and approaches.”

The idea was viewed as pushing to improve and expand the agency’s capacity for regulatory science (Also see "BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA" - Pink Sheet, 4 Jul, 2011.).

Hamburg has pushed regulatory science improvements for more than a year. The pending PDUFA agreement with industry includes provisions to devote some user fees to create a patient-reported-outcomes team and expansion of existing biomarker and pharmacogenomics units (Also see "PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers" - Pink Sheet, 2 May, 2011.).

The “Innovation” Mission

Hamburg’s also seemed to agree somewhat with BIO’s call for the change.

She told Pallone the agency still must operate in an efficient manner, using the best tools and science available.

“I think that what is really important is that we make sure that … we are doing our jobs as well as we can, which is to apply science-based, data-driven processes to our decision-making [and] do it in as modern and streamlined way as possible.”

That seems to align with BIO’s efforts, and not as big a change as the risk evaluation and mitigation strategies program in the 2007 PDUFA IV legislation, which slowed approval times until FDA and industry retooled the review machine.

Beyond that, however, Hamburg does not seem to want the agency tied in any way to economics and business growth, which is where Rogers’ bill could drive it.

The best defense against changing usually is doing what you do well, and in that respect, FDA should be heartened by its review performance recently. There were several rapidly approved drugs in the days leading up to the hearing, and last year saw the classic “pre-PDUFA bump” in the number for new molecular entities approved.

The hearing was the first of three the subcommittee will conduct on the pending user fee agreements. Janet Woodcock, director of the Center for Drug Evaluation and Research, is scheduled to appear Feb. 9 for a hearing on the generic drug and biosimilar user fee agreements (Also see "Supply Chain Security Issues To Emerge During Subcommittee Hearing On PDUFA" - Pink Sheet, 31 Jan, 2012.).

The third hearing on Feb. 15 will cover the medical device user fee reauthorization. FDA and industry Feb. 1 announced an agreement in principle, but changes Congress suggested remain possible (Also see "Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees" - Medtech Insight, 6 Feb, 2012.).

Beyond Review Fees

The four user fee agreements are expected to become one omnibus bill along with any additions from Congress. Observers do not expect a large number of new mandates for FDA in PDUFA V (Also see "Not Another FDAAA – Observers Expect Fewer FDA Reforms In PDUFA V" - Pink Sheet, 11 Jul, 2011.).

But FDA’s mission statement is not the only broader reform on the agenda. Several groups are pushing for broader use of the accelerated approval mechanism (Also see "Accelerated Approval Expansion Proposals Pending, But One Needs An Overhaul" - Pink Sheet, 6 Feb, 2012.).

The user fee renewal also may address issues related to drug shortages and supply chain integrity. Those topics, along with refining the infant generic and biosimilar programs, could be the focus of user fee renewal cycles in 2017 and beyond, because the fiscal pressures on the federal government likely will not subside. This means the agency and industry will have to focus more on user fees as a means of accomplishing shared goals.

Those new programs represent the future of the pharmaceutical industry on the business side as well; with many companies moving to a hybrid brand-generic approach, supplying drugs cheaply and reliably around the world becomes as critical a challenge as the initial innovations that created the products.

[Editor's note: This article appears courtesy of "The Pink Sheet," Elsevier Business Intelligence's source for pharmaceutical and biotech industry news. Register here for a 30-day risk-free trial – no credit card required.]