Has FDA’s ‘First In The World’ Ambition Contributed To Years Of High-Profile Safety Problems With Medical Devices?
Balancing innovation, regulation and a symbiotic relationship with the medical industry it oversees is a tricky task for the agency. The Associated Press takes a look at the FDA's push for quick approvals and how that may have lead to problems with current devices on the market.
The Associated Press:
At FDA, A New Goal, Then A Push For Speedy Device Reviews
Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. "We don't use our people as guinea pigs in the U.S.," Shuren said, holding firm as the new director of the U.S. Food and Drug Administration's medical devices division. Again and again in 2011 — four times in all — Shuren was summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices like heart valves and spinal implants, driving U.S. manufacturers overseas where products faced less rigorous review. Each time, he pushed back. And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be "first in the world" to approve devices it considered important to public health. (Perrone, 11/27)
The Associated Press:
Insulin Pumps Have Most Reported Problems In FDA Database
When Polly Varnado's 9-year-old daughter was diagnosed with Type 1 diabetes, it didn't take long for the family to hear about insulin pumps. In September 2012, the girl picked out a purple one — her favorite color. Over the next seven months, she proceeded to be hospitalized four times in a McComb, Mississippi medical center with high blood sugar. But when Varnado asked about all her daughter's problems, she said, her doctor blamed user error. (Mohr and Weiss, 11/27)
