Off-Label Communication Growth: Could FDA Afford To Police It?

Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.

Even if FDA is amenable to allowing more manufacturer communication about off-label uses, FDA may have trouble finding the money to police it.

During the second day of FDA's public hearing on the subject, one stakeholder was concerned that the growth in off-label communication would overwhelm FDA's regulatory resources.

Jack Mitchell, of the Patient, Consumer and Public Health Coalition, said a lack of adequate staffing and funding to handle it could hurt patients.

"We are concerned that the FDA does not have the resources to monitor such off-label promotion and patients will therefore be harmed," Mitchell said during the Nov. 10 session.

"It is also impossible for FDA or any other agency to ensure that off-label communications are uniformly truthful and scientifically sound in all cases. It would be an extremely resource-intensive task for any agency, which we all know has its resources stretched to the limits on an almost daily basis."

The funding issue likely will drive some conversations about potential changes to manufacturer off-label promotion policy. With significant increases of non-user fee funding difficult to secure from Congress, it likely will be difficult for FDA to receive additional money to regulate more off-label communication.

Congress has authorized more manufacturer communication about off-label drug uses, but a lack of FDA guidance has hindered it. (Also see "FDA's Off-Label Communication Changes Should Start With Payers – PhRMA" - Pink Sheet, 20 Sep, 2016.)

The agency did not address Mitchell's resource concerns during the question-and-answer period following his presentation.

Many of the agency questions focused on determining the proper dissemination of off-label information (Also see "Off-Label Communications: Industry, FDA Debate Role Of Peer Review" - Pink Sheet, 9 Nov, 2016.), as well as who would decide whether off-label information was appropriate to communicate. (Also see "‘Who Is The Arbiter?’ US FDA Asks As It Mulls Loosening Off-Label Reins" - Pink Sheet, 9 Nov, 2016.)

FDA saw a slight increase in budget authority in its fiscal year 2016 appropriations, and is currently operating under a continuing resolution. Another appropriations bill may not be passed until the new Congress arrives next year. (Also see "FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders" - Pink Sheet, 15 Feb, 2016.)

But whether there is funding for an enforcement effort or not, the agency may have to reconfigure its budget if no new money is given to support it.

Agency officials warned Congress during debate over the 21^st Century Cures legislation, which is pending in the Senate, that additional unfunded mandates could force FDA to slow its application review operation. (Also see "Congressional ‘Cures’ Debate Shifts To FDA Funding" - Pink Sheet, 30 Apr, 2015.)

Another User Fee Opportunity

As is common in discussions of new FDA responsibilities, a user fee was offered as a potential solution to the resource problem.

During the hearing's first day, Stephen Marmaras, director of state and national advocacy for the Global Healthy Living Foundation (GHLF), said FDA could "mimic its existing user fee structure in order to assure a vibrant, peer-reviewed, data-driven and regulated off-label environment."

GHLF is a patient advocate looking to improve quality of life of patients with chronic illness. The group supported increased off-label communications between manufacturers and doctors because it could improve access to needed treatments.

Marmaras said the fee could be a way to fund research of an off-label use, which could be a manufacturer requirement to allow communication about that use.

"We envision the user fee proposal as a way to potentially fund the research in the space, particularly patient-powered research networks, and really ensure a long-term solution in the same way that the user fee framework has assured long-term success for the traditional approval process," he said.

User fees related to pharma marketing are not new, but controversial.

The most famous example is the fee intended to fund review of direct-to-consumer television advertising, which was blocked by Rep. Rosa DeLauro-D-Conn.

Congress authorized the fee, but DeLauro refused to fund the program in 2007 and it subsequently died. (Also see "DTC User Fees Shot Down; Advertisers Face More Perilous Future " - Pink Sheet, 1 Jan, 2008.)

Could A New Fee Get Into User Fee Package?

Indeed, a fee proposal for off-label communications may not travel far on Capitol Hill if the proposal does not gain traction beyond the hearing.

But if industry and stakeholders are willing to support the idea, the vehicle to create a new off-label user fee will be available next year.

The prescription drug, generic drug, biosimilar and device user fee programs are expected to be renewed in 2017. The legislation likely will include a number of other changes and new programs for FDA. (Also see "Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program" - Pink Sheet, 15 Jul, 2016.)

An off-label user fee also may help FDA's Office of Prescription Drug Promotion, which has seen its enforcement letter volume decrease in the wake of the legal challenges of drug promotion practices. (Also see "FDA's Decline In Promotion Enforcement Highlighted By Celator Booth Letter" - Pink Sheet, 7 Sep, 2016.)