By way of illustration, in 1998, three out of five members of a Food and Drug Administration (FDA) advisory committee that approved a rotavirus-vaccine had financial ties to the drug companies that market that or other vaccines. Moreover, and as Congressman Dan Burton (R.-Ind.), chairman of the House Committee on Government Reform, complained last June: “I was appalled to learn that at least six of the ten individuals who participated in the [Centers for Disease Control and Prevention (CDC)] working group for the rotavirus vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines.”

Do such conflicts of interest matter? In this case, it seems so. A year after the FDA approved the vaccine, the agency declared the same vaccine unsafe and took it off the market, but not before one child died and other people suffered illnesses attributed to the vaccine.

In another instance, the FDA charged a Food Advisory Committee to review the safety of olestra, Procter and Gamble’s controversial fat substitute. In 1995, and by a 17 to 5 vote, the committee declared olestra to be safe. At least 9 of those 17 people had ties to food or chemical companies. The FDA nonetheless approved olestra. Later, both Canada and the United Kingdom rejected it. (The FDA has received almost 20,0000 reports of adverse reactions from people who believed that olestra caused them gastrointestinal problems.)

Conflicts of interest also matter because of the considerable deference that the agencies give to the recommendations of their advisory committees. Essentially, the committees become de facto regulators and establish national policy. CDC officials, for example, stated during Rep. Burton’s hearings (June 15, 2000) that their agency had not opposed the recommendations of any advisory committee in a decade or more.

In light of the rotavirus-vaccine debacle, Congressman Burton demanded to know why federal agencies permit conflicts to go largely unchecked. The answer is simple: Federal regulatory agencies deal with the conflict of interest problem by way of the highly elastic “fair balance” requirement (5 U.S.C. App. §7(b)) of the Federal Advisory Committee Act (FACA). That provision requires that advisory committees be “fairly balanced in terms of the points of view represented” and that “the recommendations of the advisory committee not be inappropriately influenced by . . . any special interest . . . .” “Balance” is not always achieved because many committees are stacked with academics whose ties to industry raise the perception, if not fact, of conflicts of interest.

While FACA formally provides for “fair balance,” it nowhere defines the terms, leaving the regulatory agencies with virtually unchecked discretion. The lack of a definite set of standards for determining fair balance has allowed some committees to be monopolized by members with conflicts that can lead to tragic incidents like those caused by the rotavirus-vaccine.

However “fair balance” is more precisely defined, any definition should operate so as to ensure a real diversity of viewpoints; that is, the “fair balance” law should prevent any one group from dominating the formulation of advisory committee recommendations. Balance, of course, should be accompanied — and would be encouraged — by full and public disclosure of conflicts of interest.

The first and most expedient path of reform is through more precise agency rule-making. While agencies like the Environmental Protection Agency and the U.S. Department of Agriculture have formulated their own regulations concerning committee balance, those regulations typically parrot the vague stipulations of FACA rather than elaborate upon them. The ambiguity in FACA reveals the need for agencies to breathe life into what is otherwise a seemingly dead-letter provision.

Alternatively, Congress could cure the statutory ambiguity problem by amending FACA to more precisely define — “fair balance.” To that end, it would be desirable to precede any such legislation with hearings on how regulatory agencies actually deal with conflicts of interest.

Finally, there is judicial review. In an appropriate case, judicial interpretation could provide the certainty necessary for enforcement and could create uniformity in agency views of — “balance.” Regrettably, the federal courts have consistently refused to answer the “fair balance” question, ruling that there is no judicially manageable standard of review for determining what constitutes fair balance. The notion is that “fair balance” is not a judicial decision but rather a political and ideological determination. See e.g., Claybrook v. Slater, 111 F.3d 904 (D.C. Cir., 1997). In other words, the federal judiciary does not believe it should try to make a bad situation better.

If federal agencies and Congress abdicate their responsibilities to usher in needed regulatory reform, the federal courts should move (albeit cautiously) to more precisely define the fair-balance requirement of FACA. Having done so, the courts could thereafter give reasonable deference to the agencies, so as not to entangle the judiciary in administrative workings.

Federal regulatory agencies, aided by expert advisory committees, establish rules that affect the air we breathe, the food we eat, the water we drink, the drugs we consume, and other activities affecting public safety and governmental oversight. Conflicts of interest in those committees undermine the integrity of the federal regulatory process. Once undermined, it is difficult to win back the public trust. That is why action must be taken now.