Despite recalls, medical device industry presses FDA to speed up approval process
Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process.
That pressure comes as a new Government Accountability Office report criticized the way the FDA handled approval of high-risk devices, such as defective artificial hips made by Johnson & Johnson that left shredded metal in patients.
More than 90,000 artificial hips were recalled last summer after studies showed that about 1 out of 8 recipients needed to have them replaced.
But the publicity surrounding such recalls obscures the fact that they make up a tiny percentage of approved products, said Jack Lasersohn, a partner at the Vertical Group, a venture capital firm in Summit, N.J.
“We fly airplanes, right? There are failures. Airplanes do crash occasionally. We don’t shut the entire industry down,” he said.
The GAO report said the FDA had been slow to close a loophole that allowed certain high-risk devices to enter the market through an abbreviated approval process because similar products were sold before current laws existed.
A disproportionate number of devices recalled because of links to serious health problems or deaths, including external defibrillators and insulin infusion pumps, had been approved under the less rigorous process, according to a separate study published this year in the Archives of Internal Medicine.
But device developers and investors such as Lasersohn worry that unless the FDA lightens the approval burden, new products and the jobs making them will migrate to countries with a lighter regulatory touch.
“Safe” means that the benefits of a drug or medical device outweigh its risks, not that it’s risk-free, Lasersohn said.
The Obama administration already has riled the device industry by taxing medical devices to help pay for the new healthcare law. Rather than lengthening product evaluations, regulators should track products more carefully once they hit the market so they can yank them quickly if problems arise, Lasersohn and others said.
The FDA needs to figure out how to analyze the information in its adverse-event reporting database swiftly, as well as Medicaid and Medicare data, said Jim Keller, vice president for health technology evaluation and safety for the nonprofit ECRI Institute, which tests medical products for healthcare providers.
“There currently is not a good way to do that,” Keller said.
Diana Zuckerman, president of the nonprofit National Research Center for Women and Families and the main author of the Archives of Internal Medicine report, agreed that improving so-called post-market surveillance is crucial.
But so is more stringent testing for products currently subjected to the less rigorous standards if they “are potentially dangerous in predictable ways,” she said in written testimony to a Senate committee last week.
Lives could be saved, patients would spend less time in the hospital, and “billions of Medicare dollars could be saved as well,” Zuckerman said.
Jeffrey Shuren, head of the FDA’s medical device office, acknowledged that the approval process was costly and cumbersome.
“We know that medical device development is expensive. And we agree that, in many areas, insufficient clarity, consistency and predictability on our part contributes to those expenses,” Shuren said in a statement submitted to lawmakers last week.
He noted that the agency had proposed a streamlined process for evaluating lower-risk devices.
On Jan. 19 — a day after President Obama promised to refine regulations that would “keep patients safer while getting innovative and lifesaving products to market faster” — the FDA deferred for further study several proposed rules opposed by the medical device industry.
Still, there are limits to how much the FDA is willing to smooth the approval process. Shuren caused a transatlantic dust-up this year when he suggested that European patients may be “guinea pigs” for medical devices approved in countries with less oversight.
“We don’t use our people as guinea pigs in the U.S.,” Shuren said.
