Transparency meeting: What’s behind FDA enforcement, asks industry

The day-long meeting was set up by FDA in an attempt to promote easy access to information on the agency’s activities.

As part of the Obama Administration’s commitment to government transparency and accountability, FDA said it is seeking “to take appropriate action (…) to disclose information to the public rapidly, and in a form that is easily accessible and user friendly”. ​

“Executive departments and agencies have been charged with harnessing new technologies to make information about agency operations and decisions available online and readily available to the public. Further, executive departments and agencies have been instructed to solicit public input to identify information of greatest use to the public,”​ said FDA in its notice on today’s meeting.

Topics up for discussion include the type of information FDA should be providing about enforcement actions, product approvals and recalls. Attendees will also discuss the tools and processes that can be implemented in order to improve access to information.

Transparency in enforcement​

According to the dietary supplements trade group Natural Products Association (NPA), which is participating in the meeting, the industry’s greatest need for transparency is in the field of enforcement.

“The Federal Food, Drug, and Cosmetic Act (FFDCA) is a strict liability statute, one in which a violation is subject to misdemeanor penalties. With that said it is unclear as to why the agency has not brought more misdemeanor enforcement action against blatant violators,”​ Daniel Fabricant, PhD, NPA director of scientific and regulatory affairs, will say.

“In the supplement world there are products that are illegally masquerading as supplements that are actually unapproved drugs, primarily analogues of sildenafil and sibutramine.” ​

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“I think I speak for all in the industry and for consumers in asking why such violations aren’t met with misdemeanor enforcement action by the agency, when the law, as it stands gives the agency more than enough authority to do such.”​

When transparency falls short​

Fabricant will tell FDA that it is of “utmost importance”​ for industry sit on the same side of the table as the agency in order to understand the science and policies behind FDA’s decisions.

When this understanding is lacking, as is currently the case, it ultimately results in industry confusion and low consumer confidence in products.

A recent example of confusion caused by lacking dialogue was the way the supplement industry’s adverse event reporting system was implemented.

In the passing of this legislation, there was no discussion of the relabeling of dietary supplement products, notes Fabricant. However, since then, there have been two versions of a draft guidance that include label change recommendations.

These are not present in the law as written, nor were they discussed in either chamber or in colloquy.

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“This is just one example as to where we are unclear as to why the agency reached the conclusions that they did (…) We have had to face [numerous questions] from our members but have had no good answers from the agency as to how and why decisions were made,”​ Fabricant will say.

Task force and more meetings​

Today’s meeting – the first of its kind – is being held by an FDA Transparency Task Force, which was set up to develop recommendations on improving agency transparency.

The task force will hold a second public meeting in the fall of 2009, and is also exploring additional ways to seek public input on the issue via the internet.