FDA Proposals and Approval Process Scrutinized After Mistake Admitted

The U.S. Food and Drug Administration (FDA) has announced that it will rescind the approval of a medical patch used to treat knee pain. The FDA said it improperly granted clearance for the product in 2008 under pressure from four congressmen from New Jersey, where the maker of the patch is located, as well as from the commissioner of the FDA.

In addition, the FDA is currently proposing regulation changes that would give the agency a greater role in the medical-device approval process. The proposed changes are under debate, especially in light of the agency’s apparent susceptibility to lobbying pressure.

The FDA released a detailed report admitting that, for the first time, it approved a drug or medical device mistakenly. It will reverse the approval of a patch called Menaflex that is manufactured by ReGen and designed to treat knee pain.

According to the FDA report, the agency’s scientific reviewers had “repeatedly and unanimously” rejected approval for the patch. Their decision was overruled by agency managers, however, who succumbed to political pressure from four New Jersey senators. The four senators each had received significant campaign contributions from ReGen, which is based New Jersey.

The report also determined that the FDA commissioner at the time, Andrew C. Von Eshenbach, M.D., was inappropriately involved in the approval decision and that agency procedures had been bypassed in order to approve the product.

New or modified medical devices that are substantially equivalent to products already cleared by the FDA often gain expedited approval through the FDA’s 501(k) program. The Menaflex patch was cleared through this program, but the FDA has now stated that the patch is not substantially equivalent to an existing approved product and it is so different from earlier devices that it should have been tested more thoroughly.

The FDA has proposed revisions to the 501(k) program, and they are among the most hotly contested regulation changes presented by the agency.

Under the Medical Device Amendments to the Food, Drug and Cosmetic Act of 1938, medical devices intended to be marketed in the U.S. are categorized in one of three classes based on the potential risk they pose to the public. Class III devices “present a potential unreasonable risk of illness or injury” and require data on performance in people, data on effectiveness and safety information in the pre-market approval (PMA) process.

But the 501(k) program exempts products from the extensive PMA process if they are “substantially equivalent” to a medical device that is already FDA-approved. This means a producer can bypass the time-consuming and often expensive PMA process if it can demonstrate that its product is substantially equivalent to an existing approved device.

Substantial equivalence does not require that the new medical device be identical to an existing approved device, which is called the predicate. The regulation only demands that the new device be at least as safe and effective as the predicate. According to the FDA, a device is substantially equivalent if, in comparison to a predicate, it:

• Has the same intended use and the same technological characteristics
• Has the same intended use and has different technological characteristics that do not raise new questions of safety and effectiveness and that demonstrate that the device is at least as safe and effective as the predicate

In August 2010, the FDA issued more than 60 proposed changes to the 501(k) program that are intended to improve medical-device safety. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health said that revisions in the approval process are needed because the program has not been updated in over 30 years.

One of the proposals would create a new category for medium-risk medical devices that would require more safety studies in the PMA process. Other changes would more specifically define “substantial equivalent” and “intended use,” which could reduce the number of products that qualify for the 501(k) program. Under these changes, the FDA would be even more involved in the approval process.

Currently, about 90 percent of medical devices gain clearance through the 501(k) process. Medical-device producers generally view the program as a cheaper and faster way to get products to the market and oppose many of the proposals. A medical-device industry representative said that the proposed changes would stifle innovation and delay patient access to improved medical devices and diagnostics.

On the other side, consumer representative groups urged the FDA to draft even stronger approval-process regulations than it has already presented. Saying that the 501(k) process has failed to keep dangerous and ineffective medical devices from the market, consumer safety organization Public Citizen recommended that the FDA require clinical studies for all devices that are “implantable, life-sustaining or life-supporting.” Public Citizen also called for the agency to create a process for re-evaluating all medical devices approved in the 501(k) program that claimed substantial equivalence to a recalled product.

It is important that the agency created to protect the public from harmful and ineffective medical devices ensures that its procedures achieve that result and are followed faithfully. Requiring more evidence of safety from medical-device producers may result in better and safer products, but only if producers know that the FDA’s demands are legitimate.