FDA’s fast-track process at issue

Consumer Reports has always been an organization that looks out for consumer. They’re well-known for reviewing consumer products to find the best value and identify the lemons. Still looking out for the consumer, Consumer Reports has recently directed their criticism toward the FDA via email to their membership, particularly the procedures for accelerated approvals for devices and drugs. They argue that current procedures have allowed defective or insufficiently-tested devices into the marketplace, with harmful results for the patient.

In general, the FDA provides a path for accelerated approvals so potentially life-saving devices, therapies, and drugs make it to market sooner, when the benefit outweighs the risks. Recently, however, there have been several high-profile instances that ended in recalls and lawsuits when the outcomes went poorly.

Certainly, patients in constant pain have more liberal criteria than healthy individuals when evaluating risk and benefit. But, it is still shocking to find out that you may have inadvertently traded a painful hip for cancer due to materials that introduced high levels of cobalt and chromium into your bloodstream.

It will be interesting to see how the FDA will continue to meet the needs and safety of patient groups, device & drug manufacturers, and the public at large. In the meantime, device manufacturers may be wise to pad their budgets for a long approval process.