Patient Groups Encourage Congress to Remove Burdensome FDA Rules
Earlier this month, a group of patient foundations expressed their “deep concerns” about the issue of “current conflicts of interest statutory provisions and their impact on the appointment of experts, particularly researchers and patients, as Special Government Employees (SGE’s) on Food and Drug Administration (FDA) Advisory Committees and as otherwise needed.”
Specifically, a coalition of over 80 organizations sent a letter to Senators Tom Harkin (D-IA) and Michael Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP).
Each of these “organizations promote efforts to bring better treatments and cures to those struggling with diseases” however, “many of these conditions have no adequate treatments and, therefore, it is imperative that we challenge hurdles that impede the quality and efficiency of the treatment development process.”
The groups recognized the importance of having protections in place when persons are appointed to positions where their own financial interests might influence their service to the federal government. Nevertheless, they maintained that, “the current conflicts of interest statutes that apply to FDA have resulted in a system that is out of balance to the point that conflict avoidance is the primary driver of who serves on Advisory Committees, regardless of the extent of the conflict, the uniqueness of their expertise, or the government’s need for their services.”
The groups explained how FDA SGE’s are subject to an additional layer of statutory conflict of interest provisions beyond those that already govern SGE’s for all other departments and agencies in the executive branch. Specifically, under current law, the FDA must analyze potential committee members pursuant to Section 712 of the Food, Drug, & Cosmetic Act (FDCA), in addition to the government-wide provisions found in the Federal Advisory Committee Act and the Ethics in Government Act of 1978.
The letter asserted that, “This additional FDA-specific provision appears to drive the FDA to look only for individuals to serve as SGE’s who have virtually no financial ties to any issue that might be addressed by a given Advisory Committee.”
“While that may sound wise at first glance, in fact those with expertise in a given area often have foreseeable and unavoidable ties to the community as a result of their expertise,” the groups asserted. “Yet, under the current structure, the FDA is not allowing those individuals to serve as SGE’s, despite the fact that by doing so the FDA is being deprived of expertise by those who are best qualified.”
Two years ago, 218 positions of the 600-plus on FDA's 49 advisory committees had yet to be filled, in part because the FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view. This kind of absence rate is extremely disturbing for patients who are waiting for new treatments and products to be approved.
While supporters of the tightened rules said they were necessary to protect the public from bias and to remain objective, a study published over five years ago dispelled these concerns. Specifically, a study published in 2006 in the Journal of the American Medical Association (JAMA) examined a total of 221 meetings held by 16 drug advisory committees. Overall, the study reported that the meeting-level analysis did not show a statistically significant relationship between conflict rates (“index conflict,” “competitor conflict,” or “any conflict”) and voting patterns. From these findings, the researchers concluded that excluding advisory committee members and voting consultants with “conflicts” would not have altered the overall vote outcome at any meeting studied.
In the past few weeks and months, we have seen a renewed focus on FDA’s conflict of interest rules, with FDA Commissioner Dr. Hamburg and Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), coming out publicly and announcing that the agency needs to address these provisions. In fact, Woodcock acknowledged that, “the [conflict of interest] limits have slowed down the advisory committee process.”
Moreover, several pieces of legislation in both the Senate and House were recently introduced, which would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government, under the Federal Advisory Committee Act.
Consequently, these patient groups added their support “to eliminate the additional conflicts of interest restrictions that apply only to the FDA.” Specifically, the groups maintained that, “the existing provisions in the Federal Advisory Committee Act and the Ethics in Government Act of 1978 are adequate to safeguard against conflicts of interest, while still allowing those with the necessary expertise and perspective to serve on these very important committees.”
Moreover, the groups acknowledged that, “the specific standard for SGE’s found in 18 U.S.C. 208(b)(3) recognizes that potential SGE’s may have conflicts of interest, but allows for their service nevertheless when the need for their services outweighs the potential for a conflict of interest created the financial interest involved.”
This “standard is clear, reasonable, and balanced and appropriately recognizes that some potential SGE’s may come to the FDA with ties to the community that may pose some conflict of interest, but that the primary issue must be the government’s need for their services.”
Ultimately, the groups recognized that, “The main goal of these committees, after all, is to help the FDA to make the best decisions possible” and “FDA can only do that if it has the best, most well-informed researchers, clinicians, and patients advising it.”
As more patient groups, legislators, and healthcare stakeholders begin to press FDA and Congress to change the current conflict rules at FDA, it is becoming more likely that the currently proposed legislation noted above will be included in the PDUFA V negotiations, especially given FDA’s recent proposals to increase and enhance innovation.