FDA Device Guidances in “Transparency” Spotlight

Researchers criticize the current administration for lack of transparency because of the dearth of oversight of FDA guidance documents. At the same time, industry seems to be enjoying increased transparency with FDA.

Jim Dickinson

Roundly faulted for failing to deliver on his 2009 campaign promise to establish the most transparent government in history, President Barack Obama’s administration drew academic criticism in June for insufficient transparency in monitoring FDA guidance documents, a notorious arena of past abuses.

The criticism came in a report from two regulatory policy researchers at George Mason University’s Mercatus Center—regulatory studies vice president for policy research Richard Williams and regulatory studies program manager James Broughel.

Of 444 final guidances issued by FDA—164 or 37% of them issued by CDRH—between January 2007 and January 2015, the researchers found only one had been reviewed as required by the White House at the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA), charged with overseeing the adequacy and reasonableness of all federal agency guidances.

Williams and Broughel’s focus was more on OIRA than FDA, but the bulk of their report examined FDA guidances as Exhibit A in their case against OIRA.

That OMB office, they wrote, had been directed by President George W. Bush in a January 2007 executive order (subsequently repealed by President Obama) to review “significant” guidance documents, defined as those that could “reasonably” be expected to lead to “an annual effect of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety . . .”

Arguably, many FDA guidances could fit that definition during the currency of the Bush executive order, yet only one of them made its way to OIRA’s posted list of reviewed guidances, despite an issuance rate that Williams and Broughel estimated as averaging four documents a month during the eight years they assessed.

“[T]his suggests a serious transparency problem exists,” they wrote. “Regardless, the statistics available to the public suggest there is little OIRA oversight of FDA activities when it comes to guidance.”

Their report did not address evidence of a need for such oversight, apparently taking it as a “given” that the Bush Administration’s purposes in issuing the executive order in 2007 are still valid, despite Obama’s unexplained repeal order—which occurred on his tenth day in office, suggesting a high level of perceived priority at the time.

Since guidance issuance and implementation at FDA (and other agencies) have been controversial in recent years—notwithstanding the device industry’s current apparent satisfaction with FDA’s performance—Bush’s order and Obama’s subsequent repeal might be seen as examples of opposite White House responses to respective and competing constituencies.

Republican “smaller government” doctrine probably drove Bush to issue his stringently prescriptive, eight-section executive order aimed at curbing regulatory impositions on industry by federal agencies, and contrary Democratic “bigger government” doctrine likely drove Obama to cancel all of that in three curt, detail-free sections.

Bush was merely doing what President Reagan had done before him in the same arena a quarter-century before: reining in slippery federal agencies that had found ways of getting around White House restrictions on their activities.

In Reagan’s case, he had ordered agencies like FDA to submit then-common “guidelines” to OMB for review as if they were regulations. FDA and other agencies got around that by naming the meddlesome documents “guidances” instead, and withholding them from OMB.

Bush’s order fixed that problem, and then along came Obama’s order undoing the fix.

But can any White House change the basic nature of the beast? Perhaps so.

Over time, there has been a gradual change in the way FDA-regulated industries regard the agency’s guidance documents—a trend that may not be reflected in other federal agencies watched by Williams and Broughel.

Those who have closely observed the expansion of FDA guidances over the years, and seen how many have been interpreted and implemented by individual employees, especially at CDRH, can tell of abuses that disadvantaged individual companies, especially medical device companies.

A notorious example of this was former CDRH expert on medical device GMPs and quality systems Kimberly A. Trautman who in 2008 was accused of “legislating” new industry standards by repeatedly substituting “have to” terminology for the words “should” and “may” projected on her slides at industry meetings, according to audience members.

Three years earlier, Troutman had informally “advised” FDA inspectors preparing a Quality System Regulation-based federal court case against Utah Medical Products that FDA roundly lost on all counts. Troutman’s activism, no doubt well intentioned, was not unique—others before her and since sought to educate industry on “better” ways to come into compliance with “voluntary” guidance.

The judge in the Utah Medical case, which FDA did not appeal and has never officially acknowledged, proclaimed that when it comes to FDA guidance language and advice to industry, “many roads lead to Rome” and companies are free to take any of them.

Indeed, that is essentially what every FDA guidance now says in bold, boxed print: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”

It would be a bit of a leap to say that this standard caveat came directly from the Utah Medical precedent, especially since FDA has so thoroughly wiped it from its legal memory banks.

Rather, through successful industry lobbying efforts on Capitol Hill, the passage of successive user fee and other laws, and more importantly through FDA performance goal negotiations with device makers that those laws required, FDA guidance-writing became a much more collaborative exercise than it had been.

These days it is not unusual for industry to seek new FDA guidances and even to complain about agency slowness in completing guidances that have been too long under development.

As former FDA Office of Chief Counsel attorney specializing in medical devices Nathan Brown (now at Akin Gump Strauss Hauer & Feld) says in a recent online interview, the medical device industry is emerging from a period of significant frustration with FDA and entering into an improved regulatory environment.

He attributes this primarily to the 2012 user fee reauthorization negotiations that brought what he calls “greater transparency and consistency, particularly in the pre-market review process,” but also to the agency having more resources and more formalized procedures which have produced an overall improvement in the relationship between the two sides.

It would seem from this that FDA transparency is in the eye of the beholder—at least for now.

Jim Dickinson is MD+DI's contributing editor.

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]