FDA Approval Process: Political Lobbying

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FDA Approval Process: Political Lobbying

The Food and Drug Administration (FDA) aims to protect the health of the American people. It assures the ‘safety, efficacy, and security of human and veterinary drugs, biological products [and] medical devices,’ and states in its mission statement that it exists to help the public get the accurate, science-based information they need to use medicines to improve their health.[1] The approval of a new medical device to treat knee injuries is an example of how the FDA’s objective to work in the public interest may be obscured by political lobbying.

ReGen Biologics Inc.’s Menaflex implant reinforces damaged or weakened tissue in the knee. The device was approved by the FDA under fast-track rules, and therefore did not have to undergo clinical trials. [2] According to a report in The Wall Street Journal, scientists at the FDA had repeatedly rejected the device, but industry and political pressure led to its approval. [3]

Timeline: The Lobbying Process

  • In 2004, ReGen Biologics Inc. decided to go ahead with a $35 million clinical trial to get Menaflex approved. Fast-tracking approval was not an option at this point. [4]
  • In 2005, the clinical trial ran into trouble and the drug company ‘made an important strategic shift: It decided to seek the fast-track 510(k) approval, avoiding the need to eventually present full clinical-trial data.’[5]
  • Between August 2006 and September 2007, FDA scientists issued formal rejection letters and concluded that Menaflex did not qualify for fast-track approval. ‘To qualify, a new device must be of "substantial equivalence" to existing devices.’ [6]
  • ReGen Biologics Inc. argued that Menaflex was very similar to an approved shoulder implant and other devices, including a hernia treatment, and therefore qualified for the fast-track approval process. [7]
  • The clinical trial continued as the drug company tried to gain fast-track approval for its product.
  • In September 2006, the FDA issued a formal warning about the conduct of the clinical trial. A top ReGen executive was serving as vice chairman of a review panel whose role is to provide independent oversight of the trial, violating conflict-of-interest requirements.
  • In September 2007, the FDA issued a second rejection of fast-track status. Lawmakers were called in for help. Supporters included Democrats Sen. Robert Menendez; Rep. Frank Pallone, chairman of the Health Subcommittee of the House Energy and Commerce Committee; Rep. Steve Rothman of Hackensack; and Sen. Frank Lautenberg. [8]
  • Congressional support helped the drug company get a meeting with von Eschenbach in January 2008. Two days later, the matter was placed in the hands of Dr. Daniel Schultz, head of the FDA's device division.
  • Members of the FDA who previously had opposed Menaflex were asked to be excluded from the decision-making process.
  • In July 2008, the drug company presented its third and final application for fast-track approval for Menaflex. FDA scientists recommended issuing what would have been a third rejection letter, but the letter was never sent. [10] Instead Schultz got together a special panel of outside doctors to help decide whether Menaflex met the requirements.
  • Michael Hutton, a lobbyist for the drug company, said ‘the company didn't want the panel to have many knee-replacement surgeons, because they might stand to lose money if a new device made knee replacements less common.’ [11]
  • The drug company requested that the panel include sports-medicine experts. ‘The eight-person committee included five sports-medicine experts chosen as temporary members from outside the FDA's regular pool of orthopedic-device experts.’ It also asked that none of the FDA scientists who previously criticized Menaflex be allowed to address the committee, [12]
  • The FDA’s legal team changed the wording of the above request. Emails show the FDA's integrity office removed language from a draft letter so that it would not ‘cause significant problems for the agency.’ [13]
  • Andrew von Eschenbach, who was head of the FDA when Menaflex was approved, says: "There's something wrong with how that decision [to go the fast-track route]. We fumbled that process." He is calling for an overhaul of the way medical-devices business is regulated. [14]

References

  1. ↑ FDA FDA's Mission Statement Accessed 9 March 2009
  2. ↑ NewsInferno Lobbying, Industry Pressure Brought to Bear in Menaflex Knee Device Approval NewsInferno, 6 March 2009.
  3. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  4. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  5. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  6. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  7. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  8. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  9. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  10. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  11. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  12. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  13. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  14. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
  15. ↑ Mundy, A. Political Lobbying Drove FDA Process The Wall Street Journal, 6 March 2009.
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