The Project On Government Oversight (POGO) Blog

Lobbyists in Fight-or-Flight Mode After Getting Booted from Advisory Committees

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By MICHAEL SMALLBERG

It's now been several months since the Obama Administration finalized its policy to remove registered lobbyists from federal advisory committees. But on K Street, the battle is far from over.

The Hill reported last week about a lawsuit filed by several lobbyists who are challenging the Administration’s policy on constitutional grounds. The complaint was filed in September 2011 by six lobbyists, most of whom were serving on Industry Trade Advisory Committees (ITACs) run by the Commerce Department and United States Trade Representative (USTR).

The plaintiffs in the case are Erik Autor from the National Retail Federation; Nate Herman, who had represented the Travel Goods Association; Cass Johnson from the National Council of Textile Organizations; Stephen Lamar from the American Apparel and Footwear Association; Andrew Zamoyski, who had represented the Society of Chemical Manufacturers and Affiliates; and William Reinsch from the National Foreign Trade Council.

The lobbyists contend that the Administration’s ban violates their First Amendment rights by 

denying the benefit of committee service to individuals whose exercise of the right to petition triggers the [Lobbying Disclosure Act’s] registration requirement, while also interfering with the ability of the entities that seek the services of these lobbyists to communicate their views to the government.

In addition, the plaintiffs claim, the ban will reduce transparency and exacerbate perceptions of undue influence because lobbyists will simply de-register in order to evade the LDA requirements. They also argue that the ban is “squarely inconsistent” with the Trade Act of 1974, under which the Administration is required to “seek information and advice from representative elements of the private sector” regarding trade issues.

One of the lawyers working with the lobbyists told The Hill that the Administration’s ban is akin to excluding committee members because of their religious beliefs:

Is Industry Influence at the FDA Putting Women at Risk? The Case of the Yasmin Advisory Committee

By ANDRE FRANCISCO

Four members of a Food and Drug Administation (FDA) board charged with evaluating the risks of birth control drugs like Yaz and Yasmin had ties to the pharmaceutical companies that made them or the generic equivalent. Not surprisingly, all four members voted that the benefits of the drugs outweighed the risks, even though the risks included potentially deadly blood clots. Check out the graphic to see the breakdown of the board's vote.

Be sure to read Adam Zagorin's story from early today that goes into the background of this story and the full letter that POGO sent FDA commission Margaret Hamburg.

Andre Francisco is POGO's online producer.

Follow @andrefrancisco

House Committee Passes Legislation to Improve Oversight of Federal Advisory Committees

By MICHAEL SMALLBERG

The House Oversight and Government Reform Committee passed an important piece of legislation today that seeks to make federal advisory committees more transparent and accountable. POGO and other good government groups sent a letter to the Committee yesterday calling for passage of the "Federal Advisory Committee Act Amendments of 2011" (H.R. 3124), introduced by Representative Wm. Lacy Clay (D-MO) and Ranking Member Elijah Cummings (D-MD) along with several co-sponsors.

There are currently over 1,000 advisory committees that provide the government with guidance on critical policy issues ranging from the BP oil disaster to the approval of drugs and devices. The Federal Advisory Committee Act (FACA), passed in 1972, is designed to ensure that these committees operate in the open with opportunities for public input.

In recent years, however, agencies and committees have found ways to evade FACA’s disclosure requirements. For instance, the D.C. Circuit has ruled that FACA generally does not apply to committees that are organized and managed by private contractors, non-voting de facto committee members, and subcommittees; agencies have made appointments to advisory committees based on political and ideological factors and have failed to properly designate certain committee members as special government employees (SGEs) subject to conflict-of-interest rules; committees have been dominated by members representing special interests and members have neglected to disclose potential conflicts; and there has been significant variation in the disclosure of committee records.

H.R. 3124—which is nearly identical to legislation that passed the House with overwhelming support in the previous Congress—includes a host of sensible reforms to close these loopholes and ensure that committees are operating under a 21st-century disclosure regime. Specifically, the legislation would:

It's Final--No More Lobbyists on Federal Advisory Committees

By MICHAEL SMALLBERG

Yesterday, the Office of Management and Budget (OMB) issued final guidance on a June 2010 memorandum from President Obama seeking to remove registered lobbyists from federal advisory committees.

The President's memo instructed agencies not to appoint or reappoint federally registered lobbyists to advisory committees and other boards and commissions. President Obama explained that the policy was an extension of his Administration’s commitment to “reducing the undue influence of special interests”:

Special interests exert this disproportionate influence, in part, by relying on lobbyists who have special access that is not available to all citizens. Although lobbyists can sometimes play a constructive role by communicating information to the government, their service in privileged positions within the executive branch can perpetuate the culture of special interest access that I am committed to changing.

Not surprisingly, lobbyists and their allies are up in arms over the new policy. Last year, a group of lobbyists wrote a letter protesting the Administration’s proposal, arguing that a lobbyist ban would “severely undermine the utility of the advisory committee process” and “undermine the broader goals of transparency with respect to lobbying.” The American League of Lobbyists issued a statement yesterday describing the policy as “shameful.”

FDA's Janet Woodcock: The Substance Behind Her "Nonsubstantive" Substantive Ties to Industry

BACKGROUND The FDA's advisory panels make important drug safety decisions that affect the lives of citizens like you and me. So we need to guard against undue influence from those with a financial interest in the outcomes. Indeed, FDA Commissioner Margaret Hamburg sent a letter to agency employees that "confidence in the agency's decision making can be undermined" if there is too much reliance on experts paid by industry.

By PAUL THACKER

Dr. Janet Woodcock, who runs the FDA's new drug division, has responded to a piece I wrote about the misleading claims she's been making to the press and Congress regarding the agency's purported inability to find qualified researchers without ties to industry to sit on drug safety advisory panels.

My piece was an exhaustive, five-part analysis to counter Dr. Woodcock's claims. I also pointed out that Janet might be making statements contrary to available evidence and favorable to drug companies because of her cozy ties to industry. I pointed out that Big Pharma floated her name for FDA Commissioner to The Wall Street Journal shortly after President Obama was elected.

So how did Janet respond?

She told FDA Webview, “As far as the allegations about my putative relationship to industry, I consider those non-substantive.”

Oh, please. Why make a statement that flies in the face of the obvious? Perchance, because Janet remains blinded by her own brilliance as FDA’s seer. A couple years ago, The Wall Street Journal reported on a morale-boosting conference for 500 of the FDA’s top officials, in which a slide show presented Janet as a visionary leader alongside others such as Gandhi, Golda Meier, and Margaret Thatcher.

Behold:

FDA's Janet Woodcock: Piñata Meets Clue Stick

By PAUL THACKER

Oh, the vagaries of a hot Washington summer. Between the heat, humidity and mosquitoes is it any wonder that we gather friends and family and head for the beach to escape the city's oppression?

If Dr. Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research (CDER), leaves the District to summer on the shore, my guess is her beach rental will be packed with drug industry executives. These days, it seems like some of Janet's closest buddies are the boys and girls at Big Pharma.

To FDA insiders, she’s one of their most ardent advocates, particularly when it comes to conflict of interest standards for FDA advisory board members. And so yesterday, POGO sent a letter to FDA Commissioner Margaret Hamburg urging her not to weaken the agency’s conflict of interest standards, by focusing on facts and not what appears to be Dr. Woodcock’s personal opinions.

Even before Obama stepped foot in the White House, the drug industry began floating Dr. Woodcock’s name for FDA Commissioner in the pages of The Wall Street Journal. This vexed Congressman Bart Stupak (D-MI) who sent the President-elect an angry letter.

"Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for,” Stupak wrote, without naming Dr. Woodcock directly.

In recent months, Janet has been blowing kisses back to drug executives who are irritated that new conflict of interest rules are limiting their ability to place their paid-for experts on FDA’s safety panels. Last May, she told reporters that financial conflict of interest rules made it "tough to find knowledgeable people" to serve on advisory panels that make recommendations on drug safety.

Conflicts of Interest in FDA Advisory Committees: Are Weaker Standards on the Way?

By NED FEDER

Can a drug or device company use hidden payments to members of FDA advisory committees to ensure that that member will provide favorable advice to the FDA about their product?

Undoubtedly this has happened, though it's hard to prove. Advisory committee members are supposed to comply with the FDA’s conflict-of-interest rules, which set limits on the financial arrangements that committee members make with the medical industry. 

But the conflict-of-interest rules may be about to weaken.

Speaking to Public Citizen, a watchdog group, FDA Commissioner Margaret Hamburg said on Monday that the current conflict-of interest rules “may loosen next year.” (See coverage here, here, and here.) If the rules on the financial arrangements of advisory committee members are made more permissive, this will obviously enlarge the pool of experts from which the FDA can choose and thus allow the FDA to recruit committee members more easily. That's one of the arguments for weakening the rules. 

On the other hand, the dangers of tainted advice from advisory committee members who are biased (or bought) by a financial conflict of interest are well known.

POGO is not using the present blog post to take a stand on the issue of tighter versus looser rules on conflicts of interest. However, we do want to champion a related change. We believe that many of the private financial arrangements made by advisory committee members should be subject to full public disclosure.

Currently, each prospective member of an FDA advisory committee must send the FDA a Confidential Financial Disclosure Report (CFD report) on Form FDA 3410. For a few members of the advisory committee, some of that information may be made public (for example, if there’s a waiver for that member). With this unusual exception, however, the information on the CFD report of all advisory committee members remains strictly confidential, sealed within the files of the FDA.

We recommend that the FDA make it a practice of publicly releasing each committee member’s CFD report, suitably redacted if necessary. (Of course, the member's permission would be needed in advance and as a condition for joining the committee.) Without these disclosures, we are forced to trust FDA officials, who've been wrong in the past, to make the right decision, privately, on the sensitive issue of advisory committee membership. Clearly the public interest will be better served in this case, as in many others, by full disclosure.

If Commissioner Hamburg goes through with her plans to weaken the current conflict-of-interest rules, the full disclosure of financial arrangements will become all the more important. 

For more about the value of disclosing CFD reports, see POGO's August 2010 public comment.

Dr. Ned Feder is POGO's Staff Scientist.

Image: FDA Commissioner Margaret Hamburg speaking at Public Citizen on July 25.

A Good Month for Transparency at Federal Advisory Committees

By Michael Smallberg

We wanted to take a moment to acknowledge the efforts of two agencies that are striving to provide more information to the public on advisory panels governed by the Federal Advisory Committee Act (let’s call it a FACA Friday).

The first is the General Services Administration (GSA), which recently announced the launch of a new website called eFACA that will hopefully make it easier to monitor the activities of the thousands of federal advisory committees that provide recommendations to agencies on critical policy issues. 

Under existing laws and regulations, agencies are already required to disclose certain information about advisory committees such as their membership and costs. Up until now, however, that information was mostly trapped in an online database that was exceedingly difficult to navigate.

GSA’s new webpage, eFACA, allows you to view aggregated trends—such as total annual spending on federal advisory committees ($387 million in 2010) and spending within individual agencies over the last ten years ($1.6 billion at the Department of Health Human Services)—and also makes it easier to track down information on individual committees and their members. Steven Croley, Special Assistant to the President for Justice and Regulatory Policy, described these new features in a post on the White House blog:

FACA Lift: House Passes Bill to Increase Accountability in the "Fifth Arm of Government"

Amid the flurry of legislative activity these past few weeks, the House quietly passed an important bill that will make advisory committees more balanced, fair, and accountable to the American people by closing some major loopholes in the law.

As we recently pointed out, President Obama took an important step toward restoring balance to federal advisory committees by issuing a memorandum directing agencies not to appoint any new registered lobbyists to their advisory committees.

The legislation that was just passed by the House—the Federal Advisory Committee Act Amendments of 2010 (H.R. 1320), introduced by Rep. Wm. Lacy Clay (D-MO) and co-sponsored by House Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY)—includes several measures to further improve the accountability and transparency of federal advisory committees, including:

 

White House: No More Lobbyists on Advisory Committees

On Friday, President Obama issued a memo directing the heads of executive departments and agencies not to appoint any new registered lobbyists to federal advisory committees, boards, and commissions.

The memo formalizes previous guidance in which the administration expressed its “aspiration” that lobbyists not serve on federal advisory committees, which have been called the “fifth arm of government” for the influential role they play in advising agencies, Congress, and the President on everything ranging from nuclear energy to oil and gas royalties. It also follows the spirit of previous rules issued by the administration, including its revolving door ban for lobbyists entering and leaving the government, and rules designed to limit the influence of lobbyists and outside parties on stimulus spending and bailout investments.

The White House blog states that registered lobbyists currently serving on advisory committees would be allowed to finish their term, but they can’t be reappointed once their term ends, and no new lobbyists can be appointed.

Not surprisingly, lobbyists have been fighting tooth and nail to keep their place at the table on advisory committees. Shortly after the White House first blogged about its new policy last year, a group of lobbyists serving as the chairs of the Industry Trade Advisory Committees wrote a letter protesting the administration’s proposal, arguing that a ban on lobbyists would “result in a policy making process that is less transparent and devoid of much of the expertise that US Government negotiators need to achieve a balanced trade agenda.”

Yet there’s reason to believe that industry will still have a strong presence on advisory committees, even without federally registered lobbyists. The federal advisory system is actually designed to incorporate the viewpoint of industry and other outside stakeholders. In contrast to special government employees (SGEs)—who are supposed to provide committees with their expertise on a certain topic, and are reviewed for potential conflicts of interest—representative members are expected to represent a known bias, such as that of industry. The Government Accountability Office (GAO) makes this point in its 2004 report on federal advisory committees:

Contracting - Improvement or the S.O.S.?

Take the contracting hot tub time machine back a few years to the early 1990s. Mötley Crüe was topping the charts, and government reform zealots shifted the thinking about how the government should operate, including how it should purchase good and services. Some of those reforms have been hits, others have not.

Today, the Obama administration is attempting to shift the contracting culture back to one that places a premium on spending taxpayer dollars wisely. Revolving doors have been closed, outside influences have been mitigated, contracting advice has been distributed, and acquisition memos have been published.

One aspect that hasn't changed is the endless stream of government reports highlighting failures in the contracting processes and wasteful federal spending. In March, the House Armed Services Committee's Panel on Defense Acquisition Reform issued its findings and recommendations. One reporter described the buzz around the release of the report with one word: "crickets." The report highlights the need to improve the acquisition system, requirements definitions, the work force, and financial management systems, and to increase competition. POGO can't argue with any of these recommendations, but wonders how this report is any different than other government reports that are collecting dust on book shelves. What does the DoD and Congress plan to do with the results of this study – ignore it, nibble around the edges, or make a real attempt to resolve contracting deficiencies?

A recent report by the DoD IG provides a great example of the pitfalls of poor contract planning and oversight. Due to poor contract requirements and oversight on a KBR vehicle maintenance contract (LOGCAP III task order 159) in Iraq, KBR racked up millions in costs for maintenance services that were not required. According to the report, "KBR utilization reports indicated that from September 2008 through August 2009, there were 213,570 available man-hours for tactical vehicle field maintenance services, but that only 14,068 actual man-hours were needed to perform the maintenance required by the Army." One article stated that "what the military got was as many as 144 civilian mechanics, each doing as little as 43 minutes of work a month, with virtually no oversight."

The Army has taken steps to correct the problem, but once again, taxpayers are left footing the bill. I hate to sound too skeptical, but these reports, and the long life-span of many of the problems that are identified, make me wonder if waste, fraud, and abuse are too big for the government to fix. Are these problems a mere cost of doing business? A recent State IG report says that contractor performance is directly related to federal oversight, but can we oversee everyone all the time? History repeats itself in many of these reports, but we are often stuck in the same 'ol situation (S.O.S.).

-- Scott Amey

Photo: http://www.flickr.com/photos/banfflakelouise/ / CC BY-NC-ND 2.0

Making Sure Advisory Committees Don't Go To Waste

One of the virtues of the Federal Advisory Committee Act (FACA) is that it requires the membership of advisory committees to be fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee. But as Bradford Plumer at The New Republic reports, that requirement is considered to be a hurdle to Energy Secretary Steven Chu establishing a nuclear waste policy commission. From The Vine blog:

In March, Energy Secretary Steven Chu said that he'd set up one of those ubiquitous blue-ribbon commissions to set a new course for the country's waste policy. But months later, it still hasn't materialized. And no one's sure why, though one possibility I've heard is that Chu's bogged down by the Federal Advisory Committee Act, which requires a wide variety of different viewpoints on any of these panels. Chu might simply be trying to figure out how to create a commission that isn't just destined for deadlock—not an easy task, given how contentious the waste issue is.

While it's (kind of) understandable that Secretary Chu wants to avoid deadlock, what's the point of establishing a committee with a foregone conclusion? As the Government Accountability Office (GAO) points out, the controversies over these committees examining contentious issues have surrounded concerns "that some appointments have been based on ideology rather than expertise or were weighted to favor one group of stakeholders over others."

This is precisely why the FACA requires a wide variety of different viewpoints — so any contentious issues will be dealt with and/or resolved. To again quote the GAO: "To be effective, advisory committees must be — and, just as importantly, be perceived as being — independent and balanced as a whole." And that might lead to a deadlock, but if there isn't a clear consensus among experts, that's a message that the Department of Energy (DOE) and taxpayers need to hear.

-- Mandy Smithberger