While it may be reasonable for the FDA to make changes, a lawmaker's proposal to make the FDA responsible for job creation and economic stimulus would dangerously undermine the FDA's primary responsibility to focus on drug, medical device, and food safety/efficacy. Rather than this government agency trying to regulate job growth, making changes to improve its own efficiency and procedures while continuing to insure safety and efficacy might better allow the industry itself to grow jobs and the economy.

Lawmaker Wants Change in FDA Mission

 

By Emily P. Walker, Washington Correspondent, MedPage TodayPublished: April 18, 2012
 

WASHINGTON -- The FDA's current mission statement focuses on safety, efficacy, and public health, but some think the agency's goals also should include promoting economic growth and spurring jobs -- specifically in the drug and device industries.

Congress is considering massive legislation that would reauthorize user fee programs for makers of medical devices and drugs and extend those programs to makers of biosimilars and generic drugs.

The House version of that legislation contains a provision that would change the mission statement of the FDA.

The current one says that the agency is responsible for "protecting the public health by assuring the safety, efficacy and security" of human and animal drugs, biologics, devices, foods, and cosmetics.

It also says that the agency is responsible "for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable."

The proposed revision -- written by Rep. Mike Rogers (R-Mich.) -- says that the FDA "protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act."

The FDA has been the subject of much criticism from industry -- especially the medical device industry -- over an approval process that the industry charges is riddled with excessive wait-times and a lack of consistency in FDA approval decisions. The hostile approval climate has led many companies to seek approval overseas instead of in the U.S., which has also led to a loss of U.S. jobs, according to device makers.

The issue of changing the mission statement of the agency to focus on job creation and economic growth was first brought up several weeks ago during a congressional hearing and emerged again Wednesday during a House Energy and Commerce Health Subcommittee hearing on user fees.

During the Wednesday hearing, Jeffrey Shuren, MD, head of the FDA's device division, said he is opposed to including anything about jobs and promoting economic growth in the FDA's mission statement.

"Jobs where? Jobs for who?" Shuren said. "Is that really a condition of when a device comes to market?"
Currently scientists at the FDA decide if a device is safe and effective and thus whether it should be approved, and scientists wouldn't be equipped to do a job-growth analysis of a particular approval decision, Shuren said.

Not to mention the headaches that the provision might bring the agency in courtrooms, where Shuren said he could foresee a device or drug company suing the agency if a particular approval failed to spur jobs.

"Let's focus on getting safe and effective devices to patients in a timely manner," he told MedPage Today during a break in the hearing. "That protects patients."

Janet Woodcock, MD, head of the FDA's Center for Drug Evaluation and Research, also expressed disapproval at the idea of tinkering with the FDA's mission statement.

Michael Carome, MD, deputy director for health research at the consumer protection group Public Citizen, told MedPage Today that the change in mission is a "very bad idea."

"The FDA's primary and perhaps sole mission should be to protect patient health and to ensure medical products are safe and effective, and by adding to their mission the promotion of innovation and promotion of job growth, that undermines the primary mission of the FDA," he said.

Public Citizen sent the subcommittee a letter opposing the change and outlining other problems the group has with the larger proposal.

Carome added that the mission statement change is something he suspects is being pushed by industry, but he doesn't think it is in the best interest of patients. AdvaMed, one of the trade groups for the medical device industry, declined to comment.

The Pharmaceutical Research and Manufacturers Association (PhRMA), the trade group for the drug industry, said it has no position on the proposed change in mission statement.

One of the three doctors on the congressional panel, Rep. Michael Burgess, MD, (R-Texas), said he supported the concept of the FDA encouraging innovation with its regulatory decisions. But "whether it requires a change in the mission statement, I don't know," he said.

Rogers' office did not immediately respond to request for comment.