Product News and Recalls

Deal Between FDA, Medical Device Makers Could Put Consumers At Risk

FDA and drug makers renegotiate reporting agreementCongress is planning to vote on a deal between the medical device industry and the FDA that could come at great risk to consumers, according to the New York Times. The agreement between the two parties is renegotiated every five years and focuses heavily on the fees that medical device companies pay the agency to review their products.

The most concerning part of the proposed agreement comes in the form of a change to reporting requirements. Currently, reports of malfunctioning medical devices are reported to the agency by hospitals and manufacturers on a monthly basis. And, even under those requirements, the FDA has stated that it already believes that “mishaps are vastly under-reported.”

The new requirements would only require quarterly reports to be filed.

Consumer advocate groups have already called attention to the point that a device’s lack of initial harm to a patient population in no way guarantees the safety of that device. Many devices are shown to be harmful and even dangerous long after their introduction to the market. Four widely used devices in particular were easily questioned: cardiac defibrillators for weak batteries, power morcellators for laparoscopic surgery that spread cancer, breast implants that could lead to a rare form of cancer, and poorly designed internal scopes that become “virtually impossible” to disinfect.

The total number of problems that result from malfunctioning medical devices can never be completely known because failure to report is “likely common,” according to Dr. Jeffrey E. Shuren, director of the FDA’s Center for Devices and Radiological Health. Noting the agency’s lack of intensive monitoring over the industry, Dr. Shuren also stated that the current reporting system is already “passive surveillance.” One can easily infer the dangers of it becoming even moreso.

In addition to lightening reporting requirements, the proposed new terms with the medical device industry also call for the FDA to allow manufacturers to bring products to market faster than ever. The potential impact of devices reaching consumers faster has not been predicted, but expedition of the approval process for drugs has resulted in nearly a third of all prescription medications carrying risks that are only discovered after their release to the American public.

The FDA’s budget is directly tied to the fees paid by the medical device industry for review of their products. As a result of this blatantly obvious conflict of interest, the industry has increased lobbying spending. Records indicate that in just the first quarter of 2017, it has already spent more than $8 million to buy influence with lawmakers.

The well-known revolving door at the FDA that gives roles to medical device and pharmaceutical industry executives who then guide policy may already be interfering with the agency’s ability to protect the public. A congressional vote to reduce the requirement to report defective and dangerous medical devices could let millions of unassuming consumers use dangerous products that no one would know could cause harm until it was too late.