Report Raises Questions About FDA's Approval of Knee-Surgery Device
Saturday, September 26, 2009
In making its bid to get a controversial knee-surgery device approved by the Food and Drug Administration, ReGen Biologics relied heavily on two consultants with strong ties to Congress and the FDA, according to records and interviews.
Mark A. Heller, who briefly registered as a lobbyist for ReGen in 2007, previously worked as the FDA's associate chief counsel for medical devices. The FDA said Heller had regular contact with the agency about ReGen's Menaflex device, which was approved over FDA staff objections last December.
Another top ReGen consultant, Michael H. Hutton, is a former chief of staff for Sen. Robert Menendez (D-N.J.), who was among four lawmakers who signed a December 2007 letter urging the FDA to review the case. ReGen has paid Hutton nearly $300,000 for lobbying services over the past two years, according to disclosure records.
Hutton has also contributed nearly $40,000 to Menendez and three other Democrats who wrote a letter to the FDA urging action in the case, campaign finance records show.
The two consultants were part of an aggressive campaign by ReGen to gain approval for the Menaflex, which is a surgical mesh used to help repair torn knee tissue. An unusual report released this week by the FDA concluded that federal regulators appear to have been swayed by outside political pressures in approving the device despite little evidence that it was effective and concerns that it was harmful.
ReGen has spent nearly $500,000 on lobbying in Washington since 2007, according to the Center for Responsive Politics, which tracks money in politics. Three company executives also contributed $26,000 to the four New Jersey lawmakers during that time, including more than $9,000 to committees headed by Menendez, the records show.
The revelations about ReGen and the fact that the FDA is now reconsidering its Menaflex approval has alarmed the $200 billion medical-device industry, which is also seeking changes to health-care reform legislation making its way through Congress. The issue is also being closely tracked by public interest groups that have been pushing for FDA reforms.
Aides to the four New Jersey Democrats -- Menendez, Sen. Frank Lautenberg and Reps. Steven R. Rothman and Frank Pallone Jr. -- said the campaign contributions and Hutton's Capitol Hill background played no role in their decision to approach the FDA on behalf off ReGen, which is based in Hackensack, N.J. Hutton and Heller did not return messages left at their offices on Friday.
Afshin Mohamadi, Menendez's press secretary, said the case was simply a matter of "constituent services."
"When a constituent, whether it be a New Jersey family or a New Jersey business, comes to the senator with questions regarding a federal process, it's his job to listen and take it seriously," Mohamadi said.
ReGen and its employees rank among the top contributors to Rothman, giving more than $13,000 to his campaign during the last election cycle. "The congressman's actions are determined solely on what he feels is in the best interests of his constituents, his state and our country," said Rothman spokeswoman Carrie Giddins.
But David Donnelly of the Public Campaign Action Fund, which supports public financing of elections, said the ReGen case represents "an indictment of our campaign finance system."
FDA staff scientists rejected ReGen's application for approval for Menaflex three times, citing concerns that patients might have adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery.
In late 2008, ReGen appealed to then-FDA Commissioner Andrew von Eschenbach. He ordered an expedited review by a panel of independent advisers, allowed ReGen input about the composition of the panel and refused to allow FDA staff scientists who had been reviewing the Menaflex applications to address the panel.
The internal probe found that ReGen executives had unusual access to von Eschenbach and that approval came after he met several times with members of the New Jersey congressional delegation. The lawmakers asked von Eschenbach to handle the ReGen matter personally. FDA staff members described the intensity of congressional involvement in the case as "highly unusual," the report said.
Von Eschenbach, who now helps companies navigate FDA regulation at a consulting firm created last year by his former FDA chief of staff, was traveling Friday and unable to respond to questions, his assistant said.
Ned Feder, a scientist at the Project on Government Oversight, a nonpartisan watchdog group, said it is likely that intervention by members of Congress influenced the FDA's decision making. "The very fact that they're making an inquiry lets von Eschenbach and other people know that members of Congress are interested," he said. "In some cases, that can't help but influence the decisions made throughout the agency. And in any given instance, it's generally impossible to prove that anything improper took place."