There are countless U.S. patients who suffer from life-threatening conditions and whose survival depends upon the timely introduction of a medical device that might work and, then again, might not. The U.S. Food and Drug Administration wants to give hope to the seeming hopeless by expediting the approval of so-called high-risk medical devices. The agency thusly proposed and opened up for public comment, the Expedited Access Premarket Approval Application or EAP.
The EAP would be for patients with unmet medical needs for life-threatening or irreversibly debilitating conditions. The focus of this proposed process is not solely on hastening the medical device review process; it is also on speeding up the device-development process.
The manufacturer's representatives and FDA staff would collaborate on a plan for collecting scientific and clinical data that supports approval. The two staffs would interact more often and earlier in the medical device review process. Ideally, enhanced engagement and collaborative data collection would give patients in most need of medical devices a lifeline to technology sooner than the current process might allow.
A medical device approved under the proposed EAP, in the FDA's words, must:
- Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
- Represent one of the following:
1. no approved alternative treatment/diagnostic exists, or
2. a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3. offers a significant, clinically meaningful advantage over existing approved alternatives, or
4. availability is in the patient's best interest
• Have an acceptable data development plan that has been approved by the FDA
The data collection and analysis is where the best of intentions potentially can collide with unintended consequences. If the data show that more people will be harmed than healed, and a medical device maker knows this, the manufacturer needs to disclose that information instead of silently slipping a medical device under the radar and under the guise of healing the sickest. Device safety is a matter of integrity no matter how the approval process works.
The administering of GranuFlo during dialysis was linked to the onset of conditions that in many cases resulted in the patient suffering cardiopulmonary arrest during treatment. Fresenius, the manufacturer, knew it. Indeed its own medical staff wrote in a company memo about statistics bearing this out - figures that were available in 2010. But nothing was done about it until the FDA got the memo. In 2012, the FDA initiated a GranuFlo and Naturalyte Compound recall.
No matter the level of stakeholder-regulator interaction during the medical device-development process, patient safety is in many cases an integrity issue. People who have been harmed by unreasonably risky drugs and medical devices deserve justice; it does not matter how sick they are. And we at Reich & Binstock are proud to represent them.