The U.S. Food and Drug Administration (FDA) recently announced a new program to speed up development and approval of medical devices. In the early 1990s, Congress passed the Prescription Drug User Fee Act (PDUFA) intending to speed up the approval of Pharmaceutical drugs. Then in the late 1990s, we began to see the fast-tracked drugs pulled from the market and previously unreported adverse events from taking the drugs. Many patients were injured when adverse events were discovered after marketing began to the general public.
The new device program will be known as Expedited Access PMA (EAP) — the acronym refers to premarket approval. To be eligible, devices will have to be for the treatment or diagnosis of a serious condition and address some sort of unmet medical need. The same “serious” definition was used in the early 1990s PDUFA legislation, adding to the existing “life threatening” definition. Thus, all drugs treating any so called “serious” condition were entitled to be fast tracked. That proved to be a big mistake by Congress – opening the flood gates for new drugs – and Big Pharma took full advantage of it.
As part of the EAP, a device manufacturer would be expected to create a so-called data development plan that outlines all the types of testing to be performed and whether the tests will take place before or after approval. A key factor in getting the medical device to market sooner is allowing clearance based on a “reasonable assurance” of safety and effectiveness, and then relying on post-approval testing to confirm those positive attributes. It sounds like the public will be used as Guinea pigs in the post-approval process described.
When a medical device is approved through the older FDA process referred to as “PMA,” the manufacturer is given immunity from lawsuits if the product injures or kills someone. A manufacturer of a medical device may decide to manufacture and sell an already approved product. This device may follow a less restrictive process call the 510(k) procedure. If a product obtains FDA clearance through a 510(k) process, lawsuits against manufacturers are not preempted.
Approval through this new EAP process should not preempt lawsuits when members of the unsuspecting and innocent public are injured or killed. Hopefully, from a safety and public policy perspective, there will be no preemption allowed. If post-approval adverse events or studies call safety or effectiveness into question, the FDA is empowered to withdraw a product’s clearance. It’s likely we will see devices approved through the EAP process harm patients who may then have no legal recourse. Let’s hope this new approval method does not lead to either of those outcomes. If you need more information on the subject, contact Frank Woodson, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
Source: Law 360
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