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FDA Advisory Committee Members Should be Free of Conflicts-of-Interest

The Issue:

 Several congressional bills (see below) that would relax conflict of interest rules for the Food and Drug Administration (FDA) advisory committee members have been introduced in the House and in the Senate. They would lessen current standards for conflicts of interest and would roll back gains patient and consumer advocates made in the last round of Prescription Drug User Fee Act (PDUFA) reauthorization to tighten conflict of interest (COI) provisions. (See summary of current COI regulation below.)  Specifically, these bills would eliminate the tighter COI provisions that FDA advisory committees have than those existing for other agencies, including limitations on the aggregate number of waivers the FDA can issue for conflicted advisory committee panelists. Despite these calls to remove waivers, the FDA has yet to come even close to reaching these caps.  Under the PDUFA IV provision, the FDA must issue waivers to less than 12.8 percent of the total participants in advisory committee meetings in 2011, but has only had to issue waivers for 1-4 percent of members in a given month during the past year.[1]

 

While FDA staff have indicated some interest in relaxing the COI rules, FDA Commissioner Margaret Hamburg made clear, in a meeting on December 12, with the patient, consumer and public health coalition, that the FDA had not asked Congress to ease the rules.[2]  Commissioner Hamburg specifically stated in the meeting that relaxing COI restrictions was not a priority for FDA and was not a major factor contributing to delays in the approval process.

Evidence of abuses prior to enactment of stricter COI rules

  •  Ten of the 32 advisors on FDA advisory committees considering whether painkillers Bextra, Vioxx and Celebrex should be permitted to continue to be marketed had financial ties to the makers of the drugs. In the case of the Bextra and Vioxx votes, committee votes to permit the continued marketing of the drugs made a difference. The vote to continue the marketing of Bextra was 17 to 13; nine of the conflicted experts voted yes. [3]
  •  Sen. Enzi and others in Congress have voiced concern about the role of conflicted experts – certain plastic surgeons with ties to implant makers — on an advisory panel that in 2005 recommended the re-entry of silicone breast implants into the market.[4]
  •  The Union of Concerned Scientists surveyed FDA scientists between 2005 and 2007 and found that more than 370 agency scientists did not believe that the FDA was acting effectively “to protect public health,” and more than 300 scientists knew of instances where corporate interests had used inappropriate influence to get the FDA to reverse, modify or withdraw decisions.[5]

 

Evidence of Availability of Conflict Free Experts

 

There are a large number of potentially qualified individuals who are from different fields:

 

 

Individuals Number
Medical School Faculty

128,000

Pharmacy School Faculty

5,600

Public Health Faculty

4,600

Source: Susan Wood, FDA Advisory Committees and Qualified Potential Members, George Washington University

 

Research suggests that nearly half of all academic researchers do not have industry ties.[6]

Position of the Patient, Consumer, Public Health Coalition

The coalition opposes all weakening of current law, but if the issue comes up, we suggest the following counter-amendments:

  •  Require FDA to conduct a two-year look back for financial conflicts instead of the current one-year look back. Require panelists to sign an agreement that they will not take industry money for one year after the panel completes its work.
  • Where a waiver for one member is granted, add an additional non-conflicted consumer representative.
  • Require that IND/NDA cannot be processed until researchers’ COI statements are submitted (there is currently a regulation requiring this, but it is very frequently ignored and results in some very biased research that is used to support the NDA).
  • On all device advisory committees, the consumer representative member is non-voting; such members should be voting and also be subject to COI guidelines.
  • Exceptions to COI rules should be limited to reviews of products for rare diseases (expedited applications); there is no need for a waiver on a non-essential drug or device.
  • Any person with a COI can be called to add his or her expertise and answer questions, but may not participate in the discussion or vote.
  • Require the FDA to publicly disclose all requests by FDA scientists to make presentations of their research before an advisory panel.  If the FDA declines to grant such a request, it must publicly disclose its reasons for denying permission.
  • Require that consumer representatives who participate as leaders or officers of specific patient advocacy groups disclose the groups’ source of funding.
  • Require that the FDA disclose on its website information about the COI waivers it is granting that includes the name of the recipient of the waiver, a description of  the specific conflict the waiver addresses, the reasons for granting the waiver, and the efforts the agency made to find a non-conflicted expert.

Conflict of Interest Provisions in Current Congressional Bills
S.1700
– (Introduced by Senator Klobuchar). The bill would replace Section 712 of the Food, Drug and Cosmetic Act.  This would eliminate the disclosure requirements found in Section 712 for advisory panelists as well as the current limits on waivers. It would not only remove the caps on numbers of waivers for advisory committee members, but also no longer statutorily require public disclosure of such waivers.

H.R. 3205– Eliminate conflict-of-interest provisions that prohibit third-party accredited persons from having other significant relationships with the device industry. The proposed changes to section 523(b)(3) would allow external third-parties to have significant financial and other relationships with the device industry. Such provisions would dangerously undermine the integrity of the third-party review process. For example, companies that make or have commercial interests in different types of devices could arrange to conduct favorable third-party reviews for one another.

H.R. 3206– Significantly lessen the standards for defining conflict of interests for members of FDA advisory committees (see the proposed amendments to section 712(b)(2)); and eliminate limits on the number of waivers the FDA may grant for significant financial conflicts of interest (see the proposed amendments to section 712(c)(2)(C)).

Relevant Statutes

All federal advisory committee panelists are subject to the (1) rules of the Federal Advisory Committee Act (FACA), which provides structural and procedural requirements for advisory panels, and (2) the provisions of 18 USC 208, which places restrictions on advisory committee members’ financial conflicts.

18 U.S.C. § 208, prohibits an executive branch employee from participating personally and substantially in a particular Government matter that will affect his own financial interests, as well as the financial interests of:

  • His spouse or minor child
  • His general partner
  • An organization in which he serves as an officer, director, trustee, general partner or employee, and
  • A person with whom he is negotiating for or has an arrangement concerning prospective employment

Exemptions

Under 18 U.S.C. § 208(b)(2) provides for exemptions from these restrictions on financial interests where the financial interests is too remote or too inconsequential to affect the integrity of the employee’s services.

Waivers

The criminal financial conflict of interest statute has two separate waiver provisions:

  • 208(b)(l): A waiver issued by the employee’s agency that covers certain financial interests that are not so substantial as to affect the integrity of the employee’s services.
  • 208(b)(3): A waiver for special government employees on Federal Advisory Committee Act committees when the need for services outweighs the potential for conflicts.

The last PDUFA reauthorization process modified the Food Drug and Cosmetic Act to provide additional, more stringent conflict-of-interest requirements for FDA advisory committee panelists.  These FDA specific advisory panel rules require that, prior to a meeting of an advisory committee, members must disclose their financial interests. Members are barred from participating with respect to a particular matter considered in an advisory committee meeting if such member (or an immediate family member of such member) has a financial interest that could be affected by the member’s advice.

The Secretary can waive restriction on a conflicts for both voting and nonvoting members “where the panelist makes full disclosure of the financial interest and receives in advance a written determination made by such official that the interest is not so substantial as to be deemed likely to affect the integrity of the services which the Government may expect from such officer or employee; or where the official in charge of appointing the panelist, certifies in writing that the need for the individual’s services outweighs the potential for a conflict of interest created by the financial interest involved.”[7]

Using the number of conflicted experts as a percentage of total advisory panelist slots from the year 2007 as the base year, the Food, Drug and Cosmetic Act sets out a declining percentage of allowable conflicted panelists.

The number of exceptions at the Food and Drug Administration for members of advisory committees for a fiscal year may not exceed the following:

  • Fiscal year 2008, 95 percent of the percentage determined under clause 90 percent of the base percentage.
  • For fiscal year 2010, 85 percent of the base percentage.
  • For fiscal year 2011, 80 percent of the base percentage.
  • For fiscal year 2012, 75 percent of the base percentage.[8]

In 2008, FDA further tightened conflict-of-interest rules by putting a maximum cap of $50,000 on financial conflicts of interest.  Further, before it issues a waiver, FDA requires a showing that the waiver is necessary to afford the committee essential expertise and FDA.[9]

 

The Sunshine in Government Act amended FACA to provide specific exceptions to disclosure requirements related to public meetings including information related to national security, trade secrets and commercial or financial information obtained from a person and privileged or confidential. [10]

 

Consumers Union

January 2012



[1] US Food and Drug Administration, “Percent of Advisory Committee Members Participating in Meetings in the Month Who Were Granted Waivers.” http://www.accessdata.fda.gov/FDATrack/track?program=advisory-committees&id=AdvComm-waivers.

[2] Jeffrey Young, “Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says,” Bloomberg, Jul 25, 2011.  http://www.bloomberg.com/news/2011-07-25/conflict-of-interest-rules-may-be-relaxed-in-2012-hamburg-says.html?cmpid=yhoo

[3] Gardiner Harris and Alex Berenson, “10 Voters on Panel Baking Pills Had Industry Ties,” The New York Times, Feb 25, 2005.  http://www.nytimes.com/2005/02/25/politics/25fda.html.

 

[4] See e.g., Catharine Richert, “Senate Panel Probes Breast Implant Advisory Panel Conflict Of Interest Allegations,” FDA Week/insidehealthpolicy.com, Jul 13, 2005.  Reprinted at breastimplantinfo.org: http://ww.breastimplantinfo.org/news/fda-conflict_int.html.

[5] “Voices of Federal Scientists: Americans’ Health and Safety Depends on Independent Science,” Union of Concerned Scientists, http://www.ucsusa.org/assets/documents/scientific_integrity/Voices_of_Federal_Scientists.pdf.

[6] Darren E. Zinner, Dragana Bolcic-Jankovic, Brian Clarridge, David Blumenthal and Eric G. Campbell, “Participation Of Academic Scientists In Relationships With Industry,” Health Affairs, Nov/Dec 2009, vol. 28, no.6, pgs. 1814-1825.

[7] 21 USC §379d-1

[8] 21 USC §379d-1

[9] US Food and Drug Administration, “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees,” Aug 2008.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf.

[10] 5 U.S.C. § 552b