Marisa de Andrade at 15:39, 9 March 2009

2009-03-09T15:39:05Z

Marisa de Andrade: New page: '''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 se...

2009-03-09T15:34:35Z

New page: '''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 se...

New page

'''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.<ref>FDA [http://www.fda.gov/opacom/morechoices/mission.html FDA's Mission Statement] Accessed 9 March 2009</ref> 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. <ref>NewsInferno [http://www.newsinferno.com/archives/4937 Lobbying, Industry Pressure Brought to Bear in Menaflex Knee Device Approval] NewsInferno, 6 March 2009.</ref> 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. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

'''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. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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.’<ref>Mundy, A.
[http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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.’ <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* [[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. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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.

* [[ReGen Biologics Inc.]] ‘fixed the problem’ by limiting the executive's role on the review panel.

* 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]]. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* In December 2007, [[Menendez]], [[Lautenberg]] and [[Rothman]] signed a letter to the FDA asking Dr. [[Andrew von Eschenbach]], the FDA commissioner, to review the issue personally. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref> 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.’ <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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, <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

* 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.’ <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

*[[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. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

*[[ReGen Biologics Inc.]] has raised $9 million from investors to market Menaflex. <ref>Mundy, A. [http://online.wsj.com/article/SB123629954783946701.html?mod=googlenews_wsj Political Lobbying Drove FDA Process] The Wall Street Journal, 6 March 2009.</ref>

==References==
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[[Category:Big Pharma]]

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 ==References==
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FDA Approval Process: Political Lobbying - Revision history

Marisa de Andrade at 15:39, 9 March 2009

Marisa de Andrade: New page: '''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 se...