FDA to Create Early Warning System for Medical Devices

December 31, 2015

Hammered for its regulation of medical device safety, the US Food and Drug Administration (FDA) today proposed telling the public about "emerging signals" of possible device risk before it determines whether the risk actually exists.

Such early warnings already are issued for drugs through the FDA Adverse Event Reporting System (FAERS), a database on adverse event and medication error reports submitted to the agency. A dramatic fall-off in the number of drugs flagged for potential risk signals in FAERS since 2012 prompts FDA critics to wonder whether a similar system for medical devices will benefit the public.

In today's proposal, the FDA explained that it historically has alerted the public about safety concerns that crop up after a device goes on the market, and usually after it has determined what to do about them. Agency responses include recommendations for the "device user community" and possible regulatory action.

However, the FDA said there is a need to notify the public "about emerging signals that the agency is monitoring or analyzing, and for which the agency does not yet have specific recommendations."

"Timely communication about emerging signals is intended to provide healthcare providers, patients, and consumers with access to the most current information concerning the potential benefits and risks of marketed devices, so that they can make informed treatment choices based on all available information," the FDA said. "Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated."

Factors that might warrant an emerging signal notice to the public include the seriousness of adverse events; the likelihood of occurrence; how broadly the device is used; whether there is a disproportionate effect on vulnerable populations such as children, the elderly, and pregnant women; and the strength of evidence pointing to a causal relationship, according to the agency.

"They Are Not Addressing the Root Problems"

FDA critics fault the agency for not doing enough to ensure the safety of medical devices. Part of the problem, they say, is the FDA's 510(k) approval pathway that most devices go down. Under 510(k), a manufacturer only needs to demonstrate that its product is substantially the same as a device already on the market. There is no premarket safety testing or mandatory postmarket monitoring for adverse events. Clinicians, hospitals, and manufacturers are supposed to report adverse events linked to approved medical devices, but that does not always happen.

The FDA also hears the complaint that it is slow to investigate or withdraw medical devices that compile a poor safety record. Notable examples include power morcellators, which have been shown to disperse and upstage occult cancer in gynecological procedures, and the Essure permanent contraceptive device (Bayer Healthcare Pharmaceuticals), which has triggered a ballooning number of adverse event reports.

A physician who has campaigned for the recall of power morcellators and reform of the 510(k) process said the new FDA proposal for emerging-signal notices on medical devices is a "half measure."

"They are not addressing the root problems," said cardiothoracic surgeon Hooman Noorchashm, MD, PhD, whose wife Amy Reed, MD, PhD, underwent power morcellation during a hysterectomy and later was diagnosed with stage 4 uterine leiomyosarcoma.

"They're not safety testing the majority of devices," Dr Noorchashm told Medscape Medical News. "There's no window of active postmarket surveillance. And they're not enforcing the self-reporting mandate."

Falling Behind on Data Entry

The proposed early-warning system for devices invites a comparison with what the FDA does with adverse event reports for drugs.

The agency periodically publishes lists of drugs or drug categories to monitor based on possible signals of serious risks or new safety information identified in FAERS during a given calendar quarter of the year. The FDA cautions that a drug's appearance on these watch lists does not mean the agency has determined that the drug actually poses the health risk reported through FAERS, only that the drug is under review. In addition, the agency stresses that it is not suggesting that clinicians should stop prescribing drugs on a watch list, or that patients should stop taking them.

An examination of FAERS quarterly watch lists reveals a decided decline in the number of drugs flagged for potential risk signals during the last 5 years. In 2011, 34 drugs or drug categories made the quarterly lists. That number fell to 20 in 2012, six each in 2013 and 2014, and zero, so far, in 2015.

Table. Drugs Appearing in FAERS Watch Lists of Potential Risk Signals

2008 2009 2010 2011 2012 2013 2014 2015
42 20 14 34 20 6 6 0*

*As of December 30.

Source: FDA

Although the FDA says on the FAERS website that the watch lists are supposed to come out on a quarterly basis for the preceding quarter, lag times often exceed 3 months. Before 2012, there have been some years when only one quarter was reported.

The last quarterly watch list, posted July 30 on the FDA website, covered the fourth quarter of 2014. That notice said that there was "no new safety information to report at this time." The agency has yet to issue a watch list covering any calendar quarter in 2015.

Dr Noorchashm suspects that risk signals from FAERS are fading because healthcare providers are filing fewer adverse event reports. That explanation makes sense, he said, because the FDA's enforcement and prosecution activities are "extremely weak."

"The proverbial cops are sitting in the donut shop instead of enforcing the law," he told Medscape Medical News. "When enforcement is weak, doctors and hospitals have little impetus to self-report complications with their patients."

Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank focused on children and adults, said she does not believe that the downward trend line means that the FDA has been receiving fewer adverse event reports. Rather, the process of disseminating possible risk signals has become "moribund."

"We think FAERS information is not being made public in a timely manner," Dr Zuckerman told Medscape Medical News. She cites lack of regulatory and political will as the reason. FDA user fees collected from drug manufacturers "are dependent on speed of review for drug approvals, not on timely FAERS information," she said. "Similarly, Congress has complained about the speed of drug and device approvals, not on the speed of warning safety signals.

"Unfortunately, safety is not currently a priority at the FDA or Congress," Dr Zuckerman said.

Medscape Medical News asked the FDA to explain why the number of flagged drugs has decreased in recent years. The FDA replied in a written statement that it had entered some, but not all, of the serious safety issues reported from January 2012 through April 2015 into its computer system for monitoring drugs on a postmarket basis. The agency "is currently taking steps to enter tracked safety issues...that were not previously entered." An update of the quarterly signals notices is in the works, but "we do not have a publish date yet," the FDA stated.

The FDA did not answer the follow-up question of why it had not entered these safety issues into its computer system in a timely manner.

The agency will accept comments from the public on today's proposal for the next 60 days. The proposal explains how to submit comments.

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