Will the FDA's Fast-Track Premarket Approval Progam Help or Harm Patients?

This week, the FDA proposed another “fast-track” program meant to expedite the approval process for medical devices that are currently not available on the market, but would fulfill an unmet need for patients with severe conditions if approved for sale.

The agency hopes this, in turn, will reduce the amount of time a device spends in the development and premarket research stages in order for it to hit the market sooner.

In a statement, the FDA said its Expedited Access PMA or EAP—the short title for its “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions” program— will serve as “not a new pathway to market,” but more as a “collaborative approach to facilitate product development under the agency’s existing regulatory authorities.” The agency, to clarify, added that when seeking EAP approval for a product, medical device makers seeking premarket approval will work more closely with senior FDA employees and executives. The agency hopes this, in turn, will reduce the amount of time a device spends in the development and premarket research stages in order for it to hit the market sooner.

According to a post by industry watchdog Fierce Medical Devices, to be considered eligible for the FDA’s EAP program, a new, unapproved medical device must:

• Be intended to treat or diagnose a life-threatening or irreversibly debilitating disease of condition
• Be the only technology to treat or diagnose the condition while offering a “clinically meaning advantage” over available approved technologies or alternatives, or have its availability be in the patient’s best interest
• Have an FDA-approved data development plan

A fact worth noting is how important of a role the FDA says postmarket data will play in “ensuring that statutory standard for premarket approval is met.” In fact, postmarket research will be so vital to an EAP-approved device’s availability that the FDA, in a corresponding draft guidance titled “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval,” essentially reserved the right to withdraw a device’s formal approval—and, most likely, issue a swifter recall—if postmarket analysis casts any doubt as to a device’s safety and effectiveness. Additionally, if a company fails to follow through in conducting satisfactory postmarket research—a condition for EAP approval—the FDA will then also decide whether to revoke a device’s approval.

For those familiar with the medical device industry, the FDA’s proposed premarket approval system will most certainly evoke thoughts of the agency’s older “express checkout” product approval method, which is formally known as Section 510(k) of the Food, Drug and Cosmetic Act. When a medical device receives 510(k) clearance, it is approved for sale by the FDA as long as it is “substantially equivalent to a device already on the market. With the premarket approval program still in its proposal stage, both systems exist to benefit patients who need help now and would only suffer further if they had to wait through the FDA’s notoriously hit-and-miss standard approval process to be able to use a device that could improve their quality of life.

With the documented misfires that have received 501(k) clearance—namely a few different companies’ metal-on-metal hip implants—will the FDA’s proposed premarket approval program ultimately help patients? Or will we see a spike in lawsuits filed against medical device companies whose products could have benefited from a little more research before getting the OK for use on humans?

Really, it’s just too early to make a call on that. At the same time, it would be irresponsible to for anyone to try to make a connection between one already-operating program whose loopholes have been blamed for opening “the door for defective devices to make their way onto the market and jeopardize patient safety” and one that doesn’t officially exist yet. Either way, government regulators—and the FDA itself, for that matter—will be monitoring this one a little more closely.