Quoting from an opinion piece by Dr. Scott Gottlieb in this morning's WSJ:
"When the U.S. Congress crafted the modern device-review process, it envisioned an approval path structured much differently than drug reviews. The Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee are working on comprehensive legislation that would reinforce the FDA's mandate to be "least burdensome" when it comes to new devices. The measure would also prevent the FDA from jamming companies with draft 'guidance' documents that change the rules on innovators midstream, without advance notice or chance for comment. The bill will tell the FDA, with unusually explicit direction, how to use its existing rules to improve post-market monitoring to ensure patient safety. The FDA was recently upbraided by the Government Accountability Office for not effectively using its current recall tools even while asking for new post-market authority.
These ideas have broad bipartisan support. Congressional Democrats and Republicans have expressed concerns that the FDA's regulatory slide could be harming innovation, job creation and patient care. Sen. Michael Bennet (D., Colo.) recently brought FDA Commissioner Margaret Hamburg to Colorado for a public meeting with local entrepreneurs and health leaders to address these concerns. 'At a time when our nation's drug, biotechnology and medical device startup companies are struggling to access capital,' he said, 'we must strive to provide them with regulatory clarity and predictability.'"
The meeting in Colorado was arranged at Senator Bennet's request by the Colorado BioScience Association.
Link to wsj.com
Dr. Gottlieb, the deputy commissioner of the FDA from 2005-2007, is a practicing physician and a resident fellow at the American Enterprise Institute. He invests in medical-device companies.