FDA Medical Device Approval Based on Politics, Not Science
NOTE: The following is one of a series of case studies produced by the Union of Concerned Scientists' Scientific Integrity Program between 2004 and 2010 to document the abuses highlighted in our 2004 report, Scientific Integrity in Policy Making.
Food and Drug Administration (FDA) officials bowed to political lobbying and circumvented normal process to approve Menaflex, a knee implant made of cow collagen, over staff scientists' objections. Other FDA scientists have called public attention to systemic political interference in the approval of medical devices.
The FDA is responsible for regulating approximately 500,000 different models of medical devices manufactured by 23,000 companies.1 About two-thirds of these are low-risk devices such as tongue depressors and bandages. About one-third are considered high-risk devices, such as pacemakers and artificial joints, whose malfunction can result in injury or death.
Menaflex, a C-shaped piece of rubbery material designed to repair torn meniscus (the cushioning between knee bones), was first submitted in 2004 for approval on the basis of an ongoing clinical trial. After the trial ran into difficulty, the manufacturer, ReGen Biologics, Inc. of Hackensack, New Jersey, resubmitted the product in 2005 for a special fast-track approval process.2
The FDA's fast-track process—known as a 510(k)—exempts products from full review if they are "substantially equivalent" to ones already on the market. ReGen argued that Menaflex was substantially similar to shoulder implants that were also made of bovine collagen. Scientists on the original review committee twice declined to approve Menaflex for a 510(k), saying that because knees, unlike shoulders, bear weight and take a pounding during use, the Menaflex implant needed a separate and full evaluation.3
In response to this rejection, ReGen enlisted tbree Democratic members of congress from its home state of New Jersey to influence the evaluation process. In December 2007, Sen. Frank Lautenberg, Sen. Robert Menendez and Rep. Steve Rothman wrote to FDA chief Andrew von Eschenbach asking him to personally look into the Menaflex situation, and soon thereafter von Eschenbach met with ReGen executives. Accusing FDA staff scientists of bias and of misreading its data, the company pressed von Eschenbach to place Daniel Shultz, head of FDA's medical devices division, in charge of the review process.
According to OpenSecrets.org, Lautenberg, Menendez, Rothman and Rep. Frank Pallone received a combined $26,000 from ReGen executives.4
Dr. Shultz did take over, and soon followed ReGen's recommendations. In a July 2008 internal memo, FDA experts recommended a third rejection of fast-track approval for Menaflex.5 Instead of siding with FDA experts, Dr. Shultz took the unusual step of appointing a panel of outside experts to decide whether Menaflex warranted a 510(k) approval.
At ReGen's suggestion, the panel contained several sports-medicine doctors recruited from outside FDA's regular pool of expert reviewers. ReGen also requested that FDA scientists involved in the previous reviews be prevented from speaking to the new committee, accusing them of bias. Rep. Pallone also contacted the FDA in October 2008 to discuss the makeup and agenda of the new committee.6 In an email exchange provided to the Wall Street Journal, FDA employees removed language from a letter sent to ReGen that would have documented special treatment for the company in selecting the makeup of the advisory panel.7
Dr. Shultz approved Menaflex on December 20, 2008, saying that it was similar enough to other products to merit fast-tracking and also stating that the expert panel "clearly and unanimously" supported Menaflex's efficacy.
However the chair of that panel, Dr. Jay Mabrey, disagreed with that assessment citing disagreements among the panel members and stating that if he had known the FDA was going to cite the panel in their approval "he would have strongly spoken out against it." Dr. Mabrey also criticized the entire panel process stating, "In retrospect, I think they [the FDA] were stacking the committee to get the decision the company wanted."8
Broader Problems with Device Approval
Evidence exists that problems with the scientific integrity of medical device approval and post-market monitoring are larger than Menaflex.
In 2006, Dr. Schultz was also involved in approving a surgically implanted nerve stimulator as a treatment for depression, overruling FDA scientists who had "repeatedly and unanimously" called for its rejection (read our A-to-Z guide article on the FDA's nerve stimulator approval).
A 2006 investigation by Rep. Henry Waxman (D-CA) found a significant decline in FDA enforcement actions from 2000 to 2005 and multiple cases of reports of serious problems from FDA field inspectors being ignored by agency leadership.9 In another high-profile case, the FDA only opened an investigation into malfunctioning heart defibrillators after reports appeared in the news media.10
In late 2008, nine senior FDA scientists sent a series of letters to Rep. John Dingell (D-MI) and President-elect Obama claiming that FDA managers had "corrupted the scientific review of medical devices."11,12 The scientists complained that experts were "ordered, intimidated and coerced" by senior managers "to modify their scientific reviews, conclusions and recommendations in violation of the law."13
A 2009 report by the Project on Government Oversight uncovered a 2006 decision by FDA leadership not to enforce certain regulations on the testing of medical devices—known as Good Laboratory Practice (GLP) regulations—a decision that was extremely controversial among FDA and outside scientists, but was never subjected to public comment.14
The Government Accountability Office backed up these concerns with evidence that from 2003 to 2007, 228 medical devices, including 24 high-risk devices, were allowed to be fast-tracked and approved without any thorough review.15
In September 2009, the new FDA leadership of Commissioner Margaret Hamburg and Deputy Commissioner Joshua Scharfstein admitted the undue influence of members of congress and former Commissioner von Eschenbach in approving Menaflex, and pledged a review of the decision.16
1. Maisel, W.H. 2004. Medical device regulation: An Introduction for the practicing physician. Annals of Internal Medicine, 140:296-302.
2. Mundy, A. 2009. Political lobbying drove FDA process. Wall Street Journal, March 6.
3. Mundy 2009.
4. Harris, G. & Halbfinger, D. 2009. F.D.A. reveals it fell to a push by lawmakers. New York Times, September 24.
5. Goode, J. S. 2008. 510(k) Memorandum, Subject: ReGen Collagen Scaffold. August 14. Dr. John S. Goode was the leader of the FDA review team. Documents provided to the Wall Street Journal.
6. Mundy 2009.
7. Letter from Andrew von Eschenbach to Gerald Bisbee, and email exchange dated November 1-3, 2008. Documents provided to the Wall Street Journal.
8. Mundy 2009.
9. House Committee on Government Reform, Minority Staff, Special Investigations Division. 2006. Prescription for Harm: The Decline in FDA Enforcement Activity. Prepared for Rep. Henry A. Waxman (D-CA).
10. Meier, B. 2005. F.D.A. meets with maker of flawed heart device. New York Times, May 25.
11. FDA Scientists. 2008. Letter to Rep. John Dingell. October 14. Rep. Dingell (D-MI) was the chair of the House Energy and Commerce Committee.
12. Harris, G. 2009. Dissidents at F.D.A. complain of inquiry. New York Times, January 27.
13. FDA Scientists Letter 2008.
14. Project on Government Oversight. 2009. The FDA's Deadly Gamble with the Safety of Medical Devices. February 18.
15. U.S. Government Accountability Office (GAO). 2009. Medical Devices: FDA Should Take Steps to Ensure that High-Risk Device Types Are Approved through Stringent Premarket Review Process, January.
16. Harris & Halbfinger 2009.