WASHINGTON, DC – U.S. Senator Pat Roberts (R-Kan.) today introduced an amendment requiring the Food and Drug Administration (FDA) to provide “much-needed transparency” to their growing practice of using regulatory guidance instead of formal rulemaking. The amendment was approved out of the Senate health committee during the final mark-up of its 2016 biomedical innovation bills.

“Guidance documents are supposed to be issued only to clarify regulations already on the books,” said Roberts. “The agency has issued over 600 final guidance documents since 2007, and my amendment would simply require the agency to explain why the policy being put forth is being done through non-binding guidance as opposed to formal rulemaking.”

Roberts continued, “Guidance documents are increasingly used to affect policy changes, imposing new requirements on those regulated by the agency even though these documents are not legally binding. My amendment is simple. It asks the FDA to show its work.”

Roberts’ amendment, cosponsored by Sen. Johnny Isakson (R-Ga.), was included as part of S. 2700, FDA and NIH Workforce Authorities Modernization Act, one of five bipartisan bills to modernize the Food and Drug Administration and the National Institutes of Health (NIH) to bring safe drugs and medical devices to American patients more efficiently. Today’s mark-up finishes the Senate health committee’s work on its companion legislation to the House’s 21st Century Cures Act. The next step is for the bill to head to the Senate floor for debate.

The text of the amendment is attached.

To view Senator Roberts’ remarks on the amendment, click here.

The full text of Senator Roberts’ remarks is available below:

While regulations with an economically significant impact receive extra examination from agencies and the Office of Management and Budget, guidance documents with equivalent impacts may escape cost-benefit analyses or other scrutiny.

The body of guidance documents is growing, both in volume and in importance – particularly at the FDA.

According to FDA’s guidance document database, the agency has issued over 600 final guidance documents since 2007.

Guidance documents are supposed to be issued only to clarify regulations already on the books. However, they are increasingly used to affect policy changes, and are often as effective as regulations in changing behavior due to the weight agencies and the courts give them. Accordingly, industries feel forced to comply.

My amendment is simple. It asks the FDA to show their work.

When issuing any new Level 1 guidance, my proposal would simply require the agency to explain why the policy being put forth is being done through non-binding guidance as opposed to formal rulemaking.

My intent is not to prohibit the agency from issuing guidance – they aren’t all bad. They are vital to industries the FDA regulates.

But they must be used appropriately – to guide. Not to implement new policies and avoid the requirements of the formal rulemaking process.

The list of examples is robust:

• Drastic policy changes being put forth through this means;
• Guidances containing incorrect information that it takes 10 years to fix;
• Or draft guidances that are never finalized.

And it’s not solely guidances.  They are issuing agreements, bulletins, compliance policy guides, small entity compliance guidances, memorandums – the list goes on. How small manufacturers ever manage to get a product approved through all this red tape is amazing. 

I believe some of my colleagues will share some of these examples but one I will quickly highlight is regarding evaporated cane juice.

In 2009, FDA issued draft guidance advising industry that the term “evaporated cane juice” is not the common or usual name of any type of sweetener.

Then in 2012, FDA issued Warning Letters to companies whose products identified “evaporated cane juice” as the sweetener on their labels – despite the guidance still being in draft form – which means it was not legally binding and did not even represent the agency’s position.

As a result, a number of class-action lawsuits have been filed against companies who included “evaporated cane juice” on their labels.

In this instance, the agency’s guidance practices not only created confusion and uncertainty among food manufacturers, but it caused inappropriate class-action lawsuits.

These examples about the agency’s growing reliance on sub-regulatory guidance should concern us all.

That is why I’m offering this amendment today, to shine some light on FDA’s use of guidances and ensure they are only using them when appropriate.

I would like to thank Senator Isakson for working on this issue with me and I urge all our colleagues to support this amendment.

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