The WSJ has a great piece today on the troubled history behind the Food and Drug Administration’s approval of Menaflex, a medical device intended to help heal injured knee tissue.
The FDA ended up approving the device under fast-track rules after two of its staff scientists turned down Menaflex, thanks to an “aggressive” and “adversarial” lobbying effort by its maker, ReGen Biologics, according to the Journal. And New Jersey’s congressional delegation lent a hand as well:
After the FDA’s second rejection of fast-track status, in September 2007, ReGen asked lawmakers from New Jersey, its home turf, 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.
Messrs. Menendez, Lautenberg and Rothman signed a letter to the FDA in December 2007 asking for Dr. von Eschenbach, the FDA commissioner, to review the issue personally. Mr. Menendez talked with the commissioner by phone, his office said.
Later in the story, we hear from a ReGen lobbyist, Michael Hutton, who talked about the device company’s very specific criteria for scientists who would sit on the panel evaluating Menaflex for fast-track approval:
Michael Hutton, a lobbyist for ReGen, 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.
ReGen requested that the panel include sports-medicine experts, according to documents and Mr. Hutton. It also asked that none of the FDA scientists who previously criticized Menaflex be allowed to address the committee, Mr. Hutton said.
Hutton, as it happens, is a former chief of staff to Menendez who registered to lobby for ReGen in October 2007 — around the time that the New Jersey delegation stepped in to help quell dissent at the FDA.
Hutton’s lobbying disclosure report for the first quarter of 2008 explains his mission with admirable candor: “Educating members of the NJ congressional delegation on regulatory process matters involving a NJ medical device company.” Hutton earned $120,000 in 2008 for his work on ReGen’s behalf, according to public records.
Meanwhile, staff scientists at the FDA have been rebelling for months against what they call politicization and manipulation of medical devices. One investigation was launched in November, and a formal request for removal of device-approval officials was sent to President Obama in January.
