Don’t give medical device makers more time before disclosing product woes

fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

In my practice, I see not only the major harms that patients suffer while seeking medical services, I represent consumers who incur big damages to their health and well-being due to dangerous and defective products, including medical devices.

Recent history tells us it is a horrible idea to let profit-driven companies get any sense from federal regulators that there’s any relaxation in what should be the rigorous oversight that Americans want to protect them and their loved ones from product harms. It doesn’t work to let medical device makers, doctors, or hospitals to self-police and to report problems as they please to regulators. That was one of the scathing findings of a U.S. Senate committee that reviewed how regulators cozied up to and fell asleep as dozens of outbreaks of infections tied to dirty gastrointestinal examination scopes sickened scores and led to the deaths of more than 20 patients.

Similar reporting woes have been identified with: cardiac defibrillators with problematic batteries; a surgical tool known as a morcellator that not only ground up uterine fibroids but also spread cancer-causing tissues throughout women’s bodies; and a defective blood clot filter tied to at least two dozen deaths and hundreds of other issues.

These and other cases have led consumer advocates to conclude that the FDA ought to put in place more, not less oversight and reporting rules over medical device and drug makers—and to put in major upgrades in the analysis and insights that regulators should be pulling from an avalanche of product data.

It’s disconcerting not just that Congress, as it seems by force of habit, piddled up to the Sept. 30 deadline to take up its every five-year reauthorization of the FDA’s fees structure, and, as part of that reconsideration, for the House to decide on looser reporting rules for medical device problems. It’s also hard to keep hearing comments that the FDA may be too overwhelmed and understaffed to deal with data the agency is getting on adverse incidents involving medical devices and drugs that have been agency reviewed and approved for consumer markets.

The Trump Administration, through Health and Human Services Secretary Tom Price and new FDA chief Scott Gottlieb, has pressed to make life easier for drug and medical device makers with less oversight and reporting. The administration also wants the industry to pay all costs for FDA drug and device reviews.

The former idea, as mentioned, doesn’t benefit the people whom the agency ought to most be concerned with: you and me, the taxpaying public. It’s doubtful, with the Senate still to take up a bevy of major bills, including health care, a budget, and a debt ceiling increase before September’s end, that the White House will get its FDA fee wishes. But if the sector’s funding gives its leaders even the whiff of an idea that paying for reviews should give them more say about how they’re run, we all must just say no.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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