FDA Opens Its Ears and Mind

Oct. 2, 2017
For those who argue that the FDA is either overprotecting or underprotecting the public, or take issue with FDA processes and regulations, let your voices be heard while regulators are listening

As you may recall, President Trump issued two executive orders earlier this year to investigate what can be updated to improve efficiency and reduce costs in the FDA as a whole. No matter which side of the political fence you’re on, you now have a chance to help the FDA implement these orders in a way that stays true to the Agency’s public health mission while also meeting statutory obligations.

“As part of our commitment to protect and promote the public health, we’re undertaking a comprehensive review of our regulations, says Anna Abram, FDA’s deputy commissioner for policy, planning, legislation and analysis in an FDA blog. “Our aim is to ensure that our policies and regulations keep pace with the challenges we face in protecting consumers, and the opportunities we have to improve their lives.”

The first executive order, “Reducing Regulation and Controlling Regulatory Costs” states that the executive branch is to be prudent and financially responsible in the expenditure of funds, and to manage the costs associated with complying with federal regulations. The second order, entitled “Enforcing the Regulatory Reform Agenda” seeks to alleviate unnecessary regulatory burdens placed on the American people and directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement or modification.

Each RRTF needs to identify regulations that eliminate jobs or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency or interfere with regulatory reform initiatives/policies; are inconsistent with Information Quality Act requirements; or derive from or implement Executive Orders that have been subsequently rescinded or substantially modified.

The FDA is open to all ideas - including supporting technical, scientific, economic or other data - from people and entities affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and state, local and tribal governments, as well as any other interested stakeholder. But the Dec. 7, 2017, deadline is fast approaching, so now is the time to be part of a movement and important opportunity that can have a lasting impact in the pharmaceutical industry.

In the pharmaceutical sector, the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs (including therapeutic biological products and generic drugs) is seeking comments and information to identify existing regulations and related paperwork requirements that could be modified, repealed or replaced to reduce burdens while allowing the agency to achieve its public health mission and fulfill statutory obligations.

“For example, we’re looking at places where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition,” Abram says. “We want to make sure our policies aren’t being misused in ways that thwart the competition that Congress intended when it created the modern generic drug framework. We know that vigorous generic competition can help benefit patients by lowering drug costs, which improves access to medicines. It’s one example of where a closer analysis of our existing policies can help make sure our regulations are having their intended purpose.

“We’ll use this opportunity to make sure our regulations reflect the new benefits that science and technology offer to advance opportunities for patients to improve their lives, and to strengthen our mandate to protect consumers,” she adds.

Electronic and written comments must be submitted to the FDA by Dec. 7, 2017. The www.regulations.gov electronic filing system will accept comments until midnight eastern time, and late submissions will not be accepted. Keep in mind that all submissions will be made public, however, confidential submissions may also be provided on paper and mailed. So as the old saying goes, “speak now or forever hold your peace.”

About the Author

Katie Weiler | Managing Editor