Letter to Principal Deputy Commissioner Sharfstein expressing concerns about the Food and Drug Administration Amendments Act (FDAAA)

Principal Deputy Commissioner Josh Sharfstein

U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

October 6, 2009

Dear Principal Deputy Commissioner Sharfstein:

In September 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law. Nearly two years later, it appears that many important provisions in this Act remain wholly or partially ignored. These provisions are crucial to ensure the safety of prescription drugs and medical devices, and require immediate attention.  We greatly appreciate your willingness to meet with us to discuss our concerns.

We have questions about the pace and quality of implementation of the following provisions. We look forward to working with you and Commissioner Hamburg to ensure that these provisions are implemented as Congress intended and to most effectively promote public health and safety.

I. Section 916: Action Plan for Approval

This section contains transparency language that will shine a light on the FDA drug approval process. As you know, better transparency is essential to restore the public’s faith in the approval process, which has been seriously shaken by a number of failures to safeguard the public, from products such as Vioxx, Avandia, and Ketek.  It does not appear that the agency is consistently or comprehensively disclosing information required by Section 916 on its website.  Even more troubling, the FDA has not even included this section on its  FDAAA Implementation Table, implying either that the FDA is not taking this congressional mandate seriously or erroneously believes it has provided the required transparency.

Specific problems include the following:

  • Although FDA, particularly CDER, has mostly complied with posting of summaries within 48 hours and action packages within 30 days, there certainly are exceptions: for example, Livalo (NDA #22363), approved 8/3/09, and Sabril (NDAs #22047 and #22006), approved 8/21/2009, have not had an action package or summary posted.
  • CDER has made a determination that they are only obligated to post original NDAs or BLAs, not supplements.  This is a huge gap, since frequently the supplement approvals are as controversial, if not more so, than the original approval.
  • The reviews are extremely difficult to find on the Web site, as noted by a recent paper in Journal of the American Medical Association (O’Connor AB JAMA 2009; 302:191-3).
  • Most importantly, the agency has persisted in using an outmoded process for posting action packages, which delays their posting and makes them difficult to use.  Rather than use electronic forms of action packages, which could be rapidly reviewed for material that needs to be redacted, CDER continues to require that action packages be printed out manually, redacted manually, and scanned manually. This dramatically increases the time needed to process these packages and post them, and makes it extremely difficult for the public to use.  Furthermore, this process appears to be out of compliance with section 508 of the Rehabilitation Act (FDA’s solution for the latter is for disabled users to call a number and have the document read to them over the phone!).


  1. Does the FDA have a plan and timeline for implanting this provision?
  2. Will FDA publicly disclose all of the documents regarding a drug approval as the FDAAA requires?
  3. Will FDA publicly disclose a summary review of the critical issues and disagreements within the review team and how they were resolved, as the FDAAA requires?
  4. Will FDA post these documents in a searchable, sortable database?

II. Section 1101: Policy On The Review and Clearance Of Scientific Articles Published by FDA Employees

This section will support scientists’ right to publish by requiring FDA to make publicly available written procedures to implement its policy on review and clearance of scientific articles.  This section also permits FDA scientists who have not received a response from the agency after 30 days to a request to publish in a peer-reviewed journal to proceed with publication with a disclaimer that they are not speaking for the agency.


  1. What is the current policy on the review and clearance of scientific articles?
  2. Is the current policy different from the policy prior to enactment of FDAAA?
  3. Where can this be found on the FDA website?
  4. How are you informing FDA scientists about this policy?

III. Section 701: Conflicts of Interest

We appreciate the work FDA has done to revamp its conflict of interest policy, and to publicly disclose the waivers it grants to conflicted panel members.  However, the FDAAA also requires the agency to gradually reduce the numbers of conflicted members on its advisory committees, and to ramp up its outreach efforts to solicit more non-conflicted members, such as pharmacists and faculty from schools of pharmacy and schools of public health.


  1. In its 2008 report to Congress concerning waivers for conflicted experts on FDA advisory committees, the FDA did not mention the requirement of reducing waivers by 5% from 2007 to 2008.  Was that accomplished?  Why wasn’t that information included in the FDA report to Congress?
  2. Will the FDA publicly disclose the names of the institutions and departments it has solicited for advisory committee nominees?
  3. Will it publicly disclose annually the total number of conflicted members on its advisory panels?  What efforts are underway to reduce the number of conflicted members?
  4. Will FDA continue to monitor and report on the success of its outreach programs?
  5. Has the FDA met the FY09 goal for reducing the percentage of conflicted advisory committee members?
  6. What is the time frame that the FDA uses to determine conflicts of interest?  Current calendar year, current fiscal year, previous year(s)?

IV. Section 224:  Electronic registration and listing (for medical devices)

This section requires that regulations and listings relating to medical device approval be submitted to the Secretary by electronic means, unless the Secretary grants a waiver.


The FDA has issued very few waivers.  What are the agency’s plans for making the information about these waivers public?

V. Section 225:  Report by Government Accountability Office (study of the 510(k) process)

In January 2009, GAO issued a report on the 510(k) process titled, “Medical Devices-FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process.”  The GAO pointed out that the Congress intended that class III devices should be approved through the more stringent PMA process rather than the 510(k) process and that the Safe Medical Devices Act of 1990 required that the FDA establish a schedule for doing so.  Almost 20 years later, the GAO reports that “this process remains incomplete” and in the 5 years of the GAO study, the FDA cleared 228 class III device submissions (24 class III device types) through the 510(k) process.  These devices include heart valves, hip joints, and other commonly used devices.


  1. What efforts has the FDA made to respond to the criticisms of the GAO report about the inappropriate use of the 510k process for class III devices?
  2. When will the FDA stop clearing class III devices through the 510(k) process?  If the FDA reclassified any class III devices as class II, where and when will that information be made public?
  3. What steps is the FDA taking to ensure the appropriate expertise on the Institute of Medicine panel and staff that will study the 510(k) process and in the meantime, what steps have been taken by the Commissioner to “expeditiously” ensure the appropriate regulation of class III devices?

VI. Section 226:  Unique Device Identification System

This section states that the “Secretary shall promulgate regulations establishing a unique device identification system for medical devices.”  We support establishing a mandatory registry for implanted medical devices so that patients will be notified if an implant in their body has been recalled or found to be defective.


  1. When will these regulations be established?
  2. FDA held a public workshop on unique identifiers for medical devices on February 12, 2009.  What suggestions from the workshop does the FDA consider viable?

VII. Section 229:  Study of Nosocomial Infections Relating to Medical Devices

In September 2008, GAO published the report mandated by this section of FDAA on Health-Care-Associated Infections (HAIs) in Hospitals.  The report concluded that “none of the data sources we identified provide a national estimate of the number of all HAIs in hospitals associated with medical devices.” The report also stated that improper patient examinations and treatments (such as improper insertion of urinary catheters) are the most significant factors affecting the occurrence of HAIs in hospitals.  Improper handling of sterilized medical devices was also commonly identified as a significant cause of infections.


  1. What steps are being taken by the FDA to obtain a better estimate of the number of HAIs associated with medical devices?
  2. Has or will FDA issue guidance to hospital personnel to improve the proper handling of sterilized medical devices?
  3. Will the FDA be doing a more detailed follow-up report on HAIs caused by reusable medical devices?

Section 1111. Identification of clinically susceptible concentrations of antimicrobials

Section 1111 instructs FDA to update susceptibility concentrations of antibiotics at least every 5 years. It does not designate FDA to delegate this authority to outside experts. The provisions of FDAAA emphasize that FDA should evaluate drugs throughout their lifecycle, not just until the time of approval. This applies to changes in drug effectiveness as well as adverse events. Antibiotic susceptibility changes over time based on changes in test-tube concentrations of antibiotics needed to inhibit growth of organisms, which in turn can (though not always) result in changes in effectiveness of antibiotics in human beings with infectious diseases. Guidance released by FDA to inform how implementation of this section will occur says FDA “intends” to accept “recognized national or international standards” for changing susceptibility concentrations:


  1. Why is FDA planning to outsource the determination of safety and effectiveness of antibiotics as stated in the draft guidance “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices” (June 2009) rather than have FDA scientists reviewing the data themselves?
  2. The guidance states in several places that changing susceptibilities can affect the determination of efficacy and safety of antimicrobials.  By outsourcing, is FDA tacitly acknowledging delegating their authority to determine the safety and effectiveness of antibiotics to an outside organization?
  3. If it were to outsource this work, how would the FDA eliminate potential conflicts by that contractor organization, its leadership, and by the employees involved in the work?
  4. How will FDA ensure that there is opportunity for public comment on changes in susceptibility concentrations? A footnote in the guidance states that standard setting organizations would “most likely” hold open public meetings but FDA could not require them to do so.
  5. The June 2009 FDA draft guidance and the draft guidance “Microbiological Data for Systemic Antibacterial Drug Products – Development Analysis and Presentation” released in September 2009 do not explain how the FDA will evaluate the science behind the decisions of outside contractors or upon what criteria the agency will base its decision to accept or reject their conclusions.  How will the FDA evaluate and make public the possible bias from conflicts of interest and how will that affect the FDA’s decision to accept the organization’s conclusions/recommendations?

Thank you for agreeing to meet with us to discuss the above concerns we have with implementing the FDAAA of 2007.


Breast Cancer Action
CANN (Community Access National Network)
Center for Medical Consumers
Consumers Union
GAP (Government Accountability Project)
National Research Center for Women & Families
National Women’s Health Network
The TMJ Association
Union of Concerned Scientists
David Ross, M.D., Ph.D., Patient and Consumer Coalition
John Powers, M.D., Patient and Consumer Coalition