Patients Get Personal at FDA Review Process Hearing

The U.S. House of Representatives Committee on Energy and Commerce held a recent hearing to discuss the regulation of medical devices at the U.S. Food and Drug Administration (FDA) and the impact of the Center for Devices and Radiological Health (CDRH)’s policies on patient access to care, innovation and job creation.

“The medical device industry has brought hundreds of thousands of high paying jobs to our country and life-saving, life-improving devices to our nation’s patients in a safe and efficient manner,” said Cliff Sterns (R-Fla.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations. “Unfortunately, it appears that regulatory inconsistency and inefficiency at FDA is causing innovative medical device companies to move offshore and launch their products abroad, oftentimes years before they enter the U.S. market, if at all.”

That very issue is what propelled several witnesses to share their personal experiences detailing how they were adversely affected by regulatory inefficiencies. One such witness was Carol Murphy from Fairborn, Ohio. Murphy has suffered from migraines for 40 years, and currently experiences three or four migraines with aura each week. After minimal success with every type of treatment, from beta-blockers to Botox, Murphy was prescribed oxycodone because she failed to fit medical protocols for migraine medication at the Michigan Head Pain and Neurological Institute when she turned 60.

The only time Murphy found relief was when she entered a clinical trial at Ohio State University for the transcranial magnetic stimulator (TMS). “At the end of the aura, when the pain should have started, it didn’t,” Murphy said. “For nine months, I lived like a normal person.”

The TMS was submitted to the FDA for approval in June 2006, and Murphy was told she would have to wait nine months to a year to be able to use it again.

“It’s now July of 2011, and where is my machine? That’s in England. That’s not here. I can’t get it here,” Murphy said. “We, as Americans, should not have to go to England to get medical equipment to help live a normal life. This is a product made in America, by Americans, but not for use by Americans.”

Dr. Jeffrey Shuren, M.D., J.D., CDRH director, testified that approval methods are being refined. He noted that the agency recently invited comment on any rules that might be considered obsolete, and also cited recent draft guidance that describes the FDA’s intent to exercise enforcement discretion with certain device approval procedures.

“As we continue to look for ways to improve our ability to facilitate innovation and to speed safe and effective products to patients, we must not lose sight of the benefits of smart regulation, to the industry, patients, and society,” Shuren said. “Medical device regulation results in better, safer, more effective treatments and worldwide confidence in, and adoption of, the devices that industry produces.”