The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to advance the health of U.S consumers by speeding innovations of such products. The latter is the reason the Public Citizen’s Health Research Group, the National Center for Health Research and a former FDA attorney are questioning whether the agency is fulfilling the former.
But, is the FDA simply the proverbial fox guarding the hen house?
Public Citizen argues the FDA is failing to use its authority to pull products from the market when there are a large number of adverse events associated with them and even when products harm or kill consumers.
“Once products are on the market, it’s almost an insurmountable threshold to get the agency to take action to pull them from the market,” Michael Carome, the Public Citizen’s Health Research Group’s said in an article titled “FDA rarely uses its power to recall dangerous medical devices. Why not?”
Carome pointed to the deadly female contraceptive Essure, manufactured by Bayer. The device, approved by the FDA in 2002, prevents fertilization by providing a physical barrier after it is inserted in the fallopian tubes. Problem was, the implant caused unintended pregnancies, ectopic pregnancies, abdominal perforations from device migration, irritable rashes, severe pain and fetal deaths. Bayer eventually stopped marketing it.
“In the case of [Bayer’s] Essure, had the company not voluntarily acted, I suspect FDA would not have pushed them to pull it from the market, based on statements they made over the last few years in the face of concerns,” Carome said.
Bayer’s Essure caused painful, debilitating and costly complications for years; amassing over 26,500 complaints against the product. The public can rightly wonder what is the extent of damage and consumer complaints before our “Watch Dog” agency takes action?
The FDA is armed with a regulation it rarely uses to remove dangerous products from the market. Code of Federal Regulations Title 21 enables the agency to order a manufacturer to “cease distribution of the device,” “notify health professionals and device user facilities of the order” and “instruct these professionals and device user facilities to cease use of the device” if it is determined that “there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death.”
Diana Zuckerman, the National Center for Health Research’s president, told MedTechDive the agency should “use the teeth it has” to protect consumers.
“The FDA has not taken them off the market, has not rescinded approval for specific uses, has not done a mandatory recall and has tried to put out [a] warning that the agency knows is not going to be effective,” Zuckerman said regarding laparoscopic power morcellators, which are used in hysterectomies and can spread cancer cells in the body.
MedTechDive said the FDA has wielded the regulation all of five times. As early as 1991, it recalled the Dyna Feed feeding pump for design flaws, and as recent as 2008, it recalled the Nebion MRI machine for lack of safety data.
“There have been some recalls under federal consent orders, and the FDA has in four cases taken the unusual step of banning a medical device,” according to MedTechDive. “The first time was in 1983 when it banned prosthetic hair fibers used to treat baldness because of serious risks including infections. Then in 2016, the agency simultaneously banned powdered surgeon gloves, powdered patient examination gloves and absorbable power used for lubricating surgeons’ gloves. The danger: Residue from the powder could be left behind in the body cavity, causing inflammation and scarring that could lead to complications later on. In addition, bits of latex from the gloves could bind the powder and be inhaled, putting people with latex allergies at risk.”
Jodi Scott, the former FDA attorney, said recalls cost both time and money. One, for example, could take over 1,000 working hours to complete from start to finish.
“To go to court and get an order takes a lot of time,” Scott said, noting it is far easier to “look the company in the eye and tell them we think you need to do a recall and have them do it voluntarily.”
Another problem stems from the 510(k) pre-market notice that enables manufacturers to “boot strap” approvals on the backs of existing, similar products without running independent trials or extensive evaluations. Largely, the FDA relies on the manufacturer’s representations. And yet another problem stems from the FDA being funded mostly by the industries it is supposed to monitor. This makes the 510(k) pre-market process ripe with the potential for abuse, because the FDA gives only cursory examination to these approvals.
“…the adoption of user fees has made the situation worse by allowing industry to negotiate benchmarks for FDA product reviews and other activities in return for payments for reviewing product submissions and other services,” according to MedTechDive.
Add to all of this the drugs approved without real basis of need. Over the strong objections of FDA scientists, a drug to treat Duchenne muscular dystrophy gained FDA approval. The FDA’s own scientists argued there was no sound evidence the drug provided any benefit to patients. So, why would it get approval? The drug is priced at $300,000 per year.
In 2016, drug and medical device manufacturers contributed about $2 Billion to the FDA for funding their operations budget. That was almost half the total budget for the FDA and it seems reasonable to wonder whether it is this incestuous relationship with the very industry it is supposed to regulate, which results in the FDA being a passive, sleeping on the porch, “Watch Dog”?