Bill to Provide Medical Devices to Sufferers of Rare Diseases

For far too long patients implanted with medical devices have been at the mercy of manufacturers who pretty much had total control over their products, even when those products were known to fail.

This is still a problem, but on Monday President Obama signed into law a twofer – an FDA reauthorization bill that will encourage medical device makers to develop treatments for rare diseases, but also free them from an FDA recommendation that could have created new and burdensome requirements for companies making changes to their approved devices.

Senator Al Franken (D-Minn.) introduced the bill to allow medical device companies to profit on devices that treat conditions that affect fewer than 4,000 people a year. Currently, only medical devices for children in such situations allow manufacturers to make money from them.

In the past, companies had to file for a humanitarian device exemption through the FDA,. The exemption requires that they prove the product is safe and that its benefit outweighs the risk of injury. But, in keeping with its control over the industry devices, manufacturers did not have to show clinical evidence that the product is effective.

Franken pushed the bill because Minnesota is home to one of the world’s largest medical device firms, Medtronic.

Franken stated “that he believes the current structure of the panels is ‘subjected to overly stringent rules’ that make it difficult for them to use outside experts because of perceived conflicts of interest with the private sector.”

Franken introduced the bill last year after learning, that “certain barriers in the regulatory process are making it harder to get patients the medical devices they need.”

The bill also makes it easier for some medical experts to serve on FDA panels that offer recommendations on medical devices for rare diseases.

Thom Gunderson, a medical technology analyst with Piper Jaffray Cos., stated, “The pendulum has swung too far on the types of experts excluded from FDA advisory panels, adding that it's hard to find people who haven't worked in the private sector.”