Magazine article Drug Topics

Legislators Push for Approval of Breast Examination Pad

Magazine article Drug Topics

Legislators Push for Approval of Breast Examination Pad

Article excerpt

For the first time in U.S. history, Congress may order the Food & Drug Administration to approve a medical product. Believing that overregulation on the part of the FDA has prevented a valuable device from making its way into the hands of American women, Rep. Barbara Vucanovich (R, Nev.) has introduced a bill that would force the FDA to allow the sale of a breast examination pad without a prescription.

The device in question is the Sensor Pad by Inventive Products of Decatur, III. It is a large plastic pad that reduces friction when a woman examines her breasts for lumps.

Inventive Products has been struggling with the FDA since 1985. The Sensor Pad was finally approved for sale in the United States with an Rx in December 1995.

But the company, legislators, and women's health-care advocates are still not happy with the outcome. Many believe that the Sensor Pad device is an extremely low-risk device that should not fall into the highest-risk Class III Category simply because no similar devices have ever been approved. They cite Inventive Products' struggle as a prime example of the shortcomings of the FDA approval process. However, Sharon Snider, a spokeswoman for FDA, said that "anything used in breast cancer is considered to be high risk."

The latest bill regarding Inventive's product would force the FDA to approve the nonprescription sale of the Sensor Pad. Grant Wright, president of Inventive Products, is hopeful that the device will finally make its way into the hands of consumers.

He said the device was meant to be a low-cost aid for all women. By limiting it to Rx-only distribution, women would have to pay for a visit to a doctor to obtain the $20 device. Wright also noted that most breast cancer education is conducted by community and women's health groups, which don't always have a doctor on staff to prescribe the device.

The FDA has said it would allow a doctor to issue a blanket Rx for wellness centers or hospital programs to distribute the Sensor Pad, but Wright said many doctors are unwilling to sell products because of added paperwork. …

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