March 3, 2021

Study Faults Approval Process for Medical Devices

In a report, released Friday, a panel of the Institute of Medicine found that the existing rules were never intended to provide safeguards for screening out dangerous or ineffective products. The panel urged the Food and Drug Administration to devise a new regulatory system for the so-called moderate risk devices — a category that now includes artificial hips, external heart defibrillators and hospital pumps — because the current system was not fixable.

“If you want to make sure that a product is safe and effective, you have to start by asking the question whether it is safe and effective,” said William Vodra, a member of the 12-person panel assembled by Institute of Medicine and a lawyer who has worked closely with device producers.

The report, which was commissioned by the F.D.A., follows a number of recalls of medical devices, like one involving so-called metal-on-metal artificial hips that have failed in thousands of patients, crippling some of them. Those implants received little, if any, testing in patients prior to being implanted in tens of thousands of people.

It is not immediately clear what impact, if any, the new report will have. But it is likely to set off a high-powered lobbying battle in coming months over the possible future shape of F.D.A. rules.

Even before the report’s release, allies of the industry had waged an aggressive campaign to discredit it, and had taken legal steps intended to bar the F.D.A. from adopting its recommendations.

On Friday, a trade group, the Advanced Medical Technology Association, which represents device industry giants like Medtronic, Boston Scientific and Johnson Johnson, unequivocally rejected the report, saying it did not deserve “serious consideration” from Congress or the Obama administration.

Patient advocacy groups, however, seized on the study as an affirmation that current rules allow dangerous or ineffective devices onto the market with scant review. For their part, F.D.A. officials, who had anticipated recommendations on how to improve the existing system, appeared taken back by the panel’s finding that it was unfixable.

Dr. Jeffrey E. Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement that he did not believe the existing regulatory system should be scrapped, adding that any significant changes would have to be approved by Congress. Dr. David R. Challoner, who served as the panel’s chairman, said that members of the group were stunned when they realized that the current system could not be salvaged. “We surprised ourselves,” Dr. Challoner said.

The Institute of Medicine review covered the approval system for a wide range of moderate-risk products, known as the 510(k) clearance process. It did not examine devices that carry the highest risk to patients if they fail, like implanted heart defibrillators. Those products go through a separate regulatory pathway that requires extensive testing before sale.

The big problem, the study found, is that the Congressional law that created the 510(k) pathway, the Medical Device Amendments of 1976, required producers of such products only to show that they were “substantially equivalent,” or similar, to one already on the market.

The committee’s report emphasized that its members believed most medical devices in use were safe and beneficial. But the panel concluded that existing rules had created a daisy-chain system of regulation, in which new devices simply piggy-back on earlier ones, without any examination of their safety or their value to patients.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices, the report concluded, adding, “Furthermore, that it cannot be transformed into one.” The panel also concluded that the F.D.A. should act quickly to determine whether artificial joints, such as hips, which are currently approved through the 510(k) process, should have to undergo the type of rigorous scrutiny that high-risk devices now go through prior to sale.

Another industry trade group, the Medical Device Manufacturers Association, said Friday that it was “concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies.”

Among other recommendations, the report also urged the F.D.A. to quickly tighten the way it tracked the performance of devices once they are on the market, and said the agency needed to move more quickly to stop the sales of harmful ones. It also said that the agency should better monitor software used in diagnostic tools because of the growing use of such technology.In many ways, the report is a rebuke to the medical device industry and its allies, who have been waging a campaign over the last year to dispute the need for any new regulations.

Last month, the Washington Legal Foundation, a pro-business group, filed a petition with the F.D.A. arguing that the agency was statutorily barred from adopting any of the report’s recommendations because of what it claimed was the panel’s bias.

The legal foundation argued that the Institute of Medicine, which is part of the National Academy of Sciences, had failed to balance the panel by including officials from the device industry, the investment community or patients who had benefited from devices. An F.D.A. official said the agency was happy with the panel’s composition, which included doctors, academics and three lawyers, included two who worked closely with the industry.

The report on Friday addressed several other complaints by the industry on possible new regulation, including the claim that toughened rules would slow the introduction of innovative products that could benefit patients.

The panel said there was no way of assessing, based on a review of available evidence, whether current regulations were having either a positive or a negative effect on innovation. The group, however, recommended that the F.D.A. assemble a group to review the issue.

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