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Two senators have drafted legislation they say would improve how the FDA inspects medical device companies.
Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) Feb. 15 introduced S. 404, which they say would make the Food and Drug Administration’s process for inspecting device facilities more consistent and predictable. A device industry group praised the measure.
Amanda Maddox, Isakson’s press secretary, told Bloomberg BNA in a Feb. 16 e-mail “the current device facility inspection process is not streamlined and lacks a certain amount of transparency, predictability, and consistency between facilities.”
While the bill seeks to improve the FDA’s inspection process, an attorney told Bloomberg BNA that FDA’s resources are limited and it may need more resources in order to comply with the bill’s mandates.
Maddox said this is the first time this bill has been introduced. It has been referred to the Senate Health, Labor, Education, and Pensions (HELP) Committee for consideration.
Maddox said “there is no standardized process for pre-inspection communications for routine inspections” and “schedules of inspections in terms of how long they may last are unknown and not communicated up front.” Also, there is “no requirement that inspections occur in consecutive days, so it is possible a four-day inspection lasts a month,” she said.
The bill would improve communications and inspection schedules and “would also better outline FDA’s inspections process in terms of how the industry can export products,” Maddox said.
Maddox also said “the system does not make efficient use of FDA and manufacturer resources” and “there is an opportunity to improve communication and consistency in the device facility inspections process for both FDA and device manufacturers.”
“We’ve worked with FDA on this bill and the needed changes it makes and will continue to work with FDA throughout the process,” Maddox said.
Sonali Gunawardhana, an attorney with Wiley Rein LLP in Washington, told Bloomberg BNA in a Feb. 21 e-mail the bill “would assist both the FDA and industry better plan and understand the inspections process.” Gunawardhana formerly worked at the FDA, and she advises clients on how to avoid and resolve FDA regulatory issues.
“It is a move in a direction that would require the FDA to be more transparent about a process that is not necessarily well understood by medical device companies currently,” Gunawardhana said. “As the process is designed to safeguard public health, it would create a more fluid system which would further the FDA’s mission while also allowing the medtech industry to work through compliance issues when identified.”
Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA in a Feb. 21 e-mail “at a high level, this bill seeks to address some significant themes involved in device inspections.” Thompson counsels medical device, drug and combination-product companies on a wide range of FDA issues.
“First, there has always been a tension between the auditing function of such inspections, and the law enforcement function of such inspections,” Thompson said.
Thompson said “audits, when done by third parties to achieve certification to a standard, are very predictable and well-organized. The auditors come in and do a comprehensive check, with significant advance notice and planning. They follow rigorous and written procedures in conducting the audits, with significant communication.”
Law enforcement, he said, “necessarily requires a degree of randomness. Indeed, law enforcement sometimes is supposed to be not predictable in order to guard against complacency.”
“It is the unpredictable threat of an inspection that keeps companies on their toes,” Thompson said. “Those objectives have always been at odds with one another, and this bill seems to try to pull the pendulum back from the law enforcement objectives to something closer to the auditing objectives. The theme of this bill wants to treat FDA inspections similar to third-party audits.”
Thompson said “the rationale for this is that audits require a significant amount of planning in order to be done efficiently, for both the auditor and the auditee” and “without planning, these events tend to be less efficient and very disruptive.”
Thompson said “the other major theme is driven by resources.”
“FDA has significant turnover among its investigator ranks. FDA is responsible for auditing throughout the entire domestic territory, as well as foreign territories. Like any federal agency, they need to divide those territories in the regions and then subdivide them into districts,” Thompson said. “The trick, in a resource-constrained environment, is getting all of the individual investigators in each district and in each region behaving the same way. The only way to do that is through a very significant commitment of both planning resources as well as training.”
Thompson said, “in this instance, planning is not just individual decisions on who to inspect and how often, but the development of policies and procedures to guide those” and “that takes a lot of time and effort, and FDA would say that they do the best they can with the resources they have available to them.”
“The purpose of this bill is to emphasize the need for that sort of planning and training. I anticipate that FDA will respond by saying that the purposes of the bill are sensible, but they will need more resources in order to execute its mandates,” Thompson said. “The agency may also say that there are limits to how much it can micromanage each individual investigator when the individual facts and circumstances of each inspection differ sometimes by subtle ways.”
Thompson said “on the whole, this is a very healthy discussion to have” and “it’s almost certain that everyone would agree that there are some improvements that can be made to the inspection process.” “It’s been a long time since that process was overhauled. I do think there are a lot of improvements that can be made,” Thompson said.
The Advanced Medical Technology Association (AdvaMed), a device industry group, praised the bill. “Both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients,” Scott Whitaker, president and chief executive officer of AdvaMed, said in a Feb. 16 statement.
“However, the agency’s current inspections process suffers from a lack of consistency, predictability and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner,” he said.
Whitaker said the bill “will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.”
“This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities,” Whitaker said. “We commend Sens. Isakson and Bennet for their leadership on this issue, and look forward to working with FDA, Congress and other stakeholders in advancing this important bill.”
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