Hello All,

I just to let you know the following article was posted in the “FDA Week” section of InsideHealthPolicy.com website. Too bad about the “oversight”!!!!

BOXER BILL REQUIRES TERMS OF DEVICE POST-MARKET STUDIES TO BE PUBLIC

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Date: May 23, 2008

Sen. Barbara Boxer (D-CA) introduced a bill May 15 that would require FDA to publish the terms of post-market medical device commitments and any changes made to them.

S 3020, the FDA Accountability and Transparency Act, reacts to problems that advocates for women injured by silicone breast implants have had in following the status of post-market studies for those products. But the legislation would apply to all implanted device post-market studies.

FDA often asks that manufacturers of implanted devices study their products once on the market. When FDA conditionally approved silicone breast implants in 2006, it required the two manufacturers of the implants, Mentor and Allergan, to conduct post-market studies on 40,000 women over 10 years.

Under the agreement, it was mandatory for woman receiving the implants to participate in the study. But when advocates met with FDA officials on the studies, officials said the companies were having a difficult time enrolling patients in the studies because FDA had dropped the mandatory participation at the companies’ request, according to Chris Revere of the Sheridan Group.

Revere said the changes to the study commitments pose a public health problem because women were not notified that the safety studies were slowed. When asked why FDA had not notified the public, Revere said FDA officials responded that they were not required to.

“Before the ink dries on these agreements, they’re in there trying to change the terms,” Revere said of device companies.

Boxer’s bill would require that FDA publish post-market study terms, or changes to them, in the Federal Register.

The bill also would increase the amount that FDA may fine companies that shirk their commitments. Revere said penalties available for drug companies currently are far higher than those for device makers, and the bill would bring parity.

The Advanced Medical Technology Association did not respond.

A clerical error in the FDA Amendments Act exempts device makers from having to report clinical trial adverse events to the online database established by the same law. The database serves as a listing of registry information for drug and device clinical trials, as well as their results. Adverse events from device trials do not have to be reported to the results database due to a wording oversight.

The House last year passed a corrections bill adding devices to the adverse events reporting requirement, but the bill never passed the Senate.