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As seen from a recent inquiry, Senator Charles Grassley doesn’t mind holding FDA and manufacturers accountable for any possible unapproved devices (or unapproved uses). Grassley’s name has popped up quite a bit in medical device regulatory matters:

*He fought against Andrew von Eschenbach being confirmed as FDA’s commissioner.
*He proposed a bill that, among other things, would give FDA more authority to require postmarket studies and penalize firms that fail to complete them.
*He pressed CDRH on looking into Guidant’s defibrillator problems.
*He asked von Eschenbach to investigate the investors of the start-up company that developed the Prodisc device manufactured by Synthes.
*He sent a letter to the Cardiovascular Research Foundation requesting information about its financial relationship with Abbott Laboratories and four other companies.

A penny for Grassley’s thoughts on transforming the agency…

A call from a legislator may have prompted FDA officials to override scientists and approve the sale of an imaging device for breast cancer according to agency documents, reports the New York Times. This is the latest is a long line of allegations by FDA scientists who feel officials are shepherding medical devices through approval regardless of scientific evidence for efficacy.

The House Committee on Energy and Commerce has begun its investigation, thereby making documents such as e-mails that highlighted the phone call public.

In the documents, the Times reports that former representative Christopher Shays, (R–CT) is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that helps radiologists detect breast tumors. The device in question was the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, used with screening equipment from Fujifilm Medical Systems.

Mr. Shays told the paper that he called the agency supervisor only to demand that it make a final decision, not that it approve the product. Fujifilm Medical spokesperson, Courtney Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the FDA process.”

Although it’s really FDA that is in the hot seat, industry should prepare itself. We should expect more such allegations, and without the cushion of redaction to protect the names.

A group of federal scientists is complaining of widespread managerial misconduct in FDA’s Center for Devices and Radiological Health (CDRH), according to the Associated Press. The scientists wrote a letter to the Obama transition team, saying, “The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s CDRH letterhead. A copy of the letter, with the names of the scientists redacted, was provided to AP by a congressional official.

According to AP, the letter alleges that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx. FDA declined to publicly respond to the letter, but said it is working to address the concerns.

“Managers with incompatible, discordant, and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

AP says that the letter singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Appearing in front of Congress today for his confirmation hearing, Tom Daschle, Obama’s nominee for health secretary, says that FDA has “lost the confidence” of both Americans and Congress.

In addition to being the nominee for the head of HHS, Daschle is also the chief of a White House Office of Health Reform. The former U.S. senator says, “If confirmed, I will use these dual roles to marshal the talent and energy necessary to at least succeed in making healthcare affordable and accessible for all Americans,” according to Bloomberg.