Tuesday, May 12, 2009

Who's Minding the Store at the FDA?

I have sitting in front of me a letter dated October 14, 2008 addressed to Representative John D. Dingell. Representative Dingell is the head of the Committee on Energy and Commerce in the Congress.

The first paragraph of the letter states:

“This letter seeks your urgent intervention because of serious misconduct by managers of the U.S. Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans. Mangers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).”

The letter is redacted (certain sections blacked out) including who sent the letter. It is on the letter head of the Department of Health and Human Resources which is the branch of government responsible for oversight of the FDA.

This is a five page letter that makes clear a shocking point many times over. “There is documentary evidence than managers at Office of Device Evaluation have corrupted and interfered with the scientific review of medical devices.” The documentary evidence has been characterized as “compelling, convincing and sufficient enough to justify curative and disciplinary actions.” According to this letter, the written documentary evidence would seem to include internal emails, reviews, meeting minutes, etc.

There are hundreds of medical devices that are regulated by the FDA. These include silicone and saline breast implants, cardiac stents, imaging equipment and nerve stimulators.

From the dates in this redacted letter, these accusations of corruption were first presented to FDA officials on May 31, 2008. Six months ago. It was determined by an internal FDA official that the evidence was “compelling,” “convincing,” and “sufficient” by the end of August of 2008.

So where is the public warning? What devices have been called into question? What if you or your loved one was getting a cardiac stent tomorrow or choosing to have breast augmentation or breast reconstruction with implants?

I would advocate that it is the FDA’s responsibility to sound an alarm to the public clearly and swiftly if there is any doubt on the validity of the approval process of any device they regulate. Internal investigations are called for and needed but where the public warning.

In November of 2007 there was a report issued by the FDA Science Board entitled “FDA Science and Mission at Risk.” The report states, “The industries that the FDA regulates are among the most successful and innovative in our society, and are among the few that contribute to appositive balance of trade with other countries. The importance of the FDA in the nation’s security is similarly profound…THUS THE NATION IS AT RISK IF FDA SCIENCE IS AT RISK.”

So how many people are there walking around today with one of these medical devices in question? Do they not have a right to know?

Write your elected representative and demand Congressional hearings.

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