FDA overstepping its bounds?

Agency under some fire for ordering 23andMe to shut down consumer genetic tests

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MOUNTAIN VIEW, Calif.—Ever since the U.S. Food and Drug Administration (FDA) ordered private personal genetics company 23andMe to shut down consumer access to its popular mail-order health-related genetic tests, effective Dec. 5, the federal agency has come under fire by some for overstepping its authority and denying the company—and its customers—their first amendment rights.
Silicon Valley-based 23andMe’s “database of 400,000 total individuals is a veritable treasure trove of info for genetic researchers,” techcrunch.com has reported, for example.
But the FDA contends the results of these simple genetics tests are misleading at best, and fraught with inaccuracies at worst.
In a “warning letter” on Nov. 22 to Anne Wojcicki, co-founder and CEO of 23andMe, the FDA states that 23andMe had been marketing its Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
The company’s website markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease and breast cancer, the FDA writes.
“Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act,” the FDA stated. “Most of these uses have not been classified, and thus require premarket approval or de-novo classification, as FDA has explained to you on numerous occasions.”
“As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work,” the letter further stated.
“You have not worked with us toward de-novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s and FDA has not received any communication from 23andMe since May,” the letter continued. “Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that … show you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA. Failure to take adequate corrective action may result in regulatory action including seizure, injunction and civil money penalties.”
Wojcicki’s first public response on the 23andMe website stated, “We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives. Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
Los Angeles Times columnist Michael Hiltzik believes 23andMe’s aggressive marketing campaign may have been the straw that broke the camel’s back in the eyes of the FDA. The FDA “instructed the firm to shut down its genetic analysis service, declaring—with plenty of justification—that the company’s marketing claims were running well beyond what was valid and legal,” he wrote Dec. 15.
Personal genetics testing had been building toward a kind of craze for some time, Hiltzik noted.
For example, inquiries poured into the 23andMe office in May, after actress Angelina Jolie disclosed undergoing a precautionary double mastectomy upon learning she carried a gene that predisposed her to breast cancer.
Critics of 23andMe’s services and those of competitors are quick to point out that raw genetic information is very hard for a lay person to interpret. Also, if a test inaccurately identifies something like a cancer gene, it could lead people to undergo prophylactic surgery, chemoprevention, intensive screening or other measures that could do the person harm. On the flip side, false negatives could result in failure to recognize an actual risk.
“Some people may be tempted to see this conflict as an issue of free speech, but that won’t do when the information at issue is as specialized and subject to misinterpretation as a person’s genetic profile,” Hiltzik said. “Consumers have a right to their genetic code, but they also have a right to know that the tests are technically accurate, that the interpretations conform with the state of medical knowledge and that no one is being improperly plied with either alarm or reassurance for profit.”
However, Nita Farahany, professor of law and genome sciences and policy at Duke University, asserts the FDA has overreached in ordering 23andMe to stop selling its DNA tests.
“While 23andMe is helping to democratize science, the FDA’s heavy-handed approach may derail them from doing so,” Farahany said. The company “does not offer a medical diagnosis of any condition. Just because information can help in the diagnosis of a medical condition does not mean that it should be considered a ‘medical device’ subject to FDA jurisdiction.”
“Although some people might make health decisions partly based on their 23andMe report, they make health decisions based on their fitness trackers, too,” she continued. “Is the FDA going to issue Fitbit and Nike cease-and-desist letters, too?”
“If the FDA is right, and it has regulatory jurisdiction over the PGS, then 23&Me can’t ignore it,” Farahany tells DDNews. “The company could challenge the FDA’s jurisdiction, or claim its action in this case as arbitrary and capricious under the APA, but those are difficult legal challenges to win because courts give deference to agency interpretations of its own rules and regulations.”
BakerHostetler partner David Rivkin offers a strict interpretation of the U.S. Constitution’s freedom of speech amendment.
Arguing in a Dec. 9 USA Today opinion piece, Rivkin contends the FDA is in violation of 23andMe’s first amendment rights since the FDA’s order to stop the company from continuing its services keeps genetic information out of patients’ hands and prevents them from making informed choices about treatment.
“The FDA does not claim that 23andMe is a scam or could cause direct injury,” Rivkin writes. “Instead, its concern is that people using the genome service may begin to self-manage their treatments. Essentially, the agency wants to ‘protect’ patients from knowing about their own health.”
The FDA “worries that individuals with information about their genetics could make the wrong choices,” Rivkin said. For instance, “informed of a heightened risk for breast or ovarian cancer, a person might undergo unnecessary prophylactic surgery or chemotherapy. But this could not happen without first consulting a doctor and undergoing diagnostic tests.”
The FDA’s stance “puts the agency in direct conflict with our free speech rights,” Rivkin said. “Shuttering a service such as 23andMe is no different from censoring home medical references or any myriad of websites that link symptoms with medical conditions.”
With economists predicting personal genetics testing to soon become a $25 billion business, this story is just the tip of the iceberg, and that includes actions by detractors as well as supporters. For example, Bloomberg recently reported that some clients claim 23andMe misled them about the accuracy and validity of its tests, and on Nov. 27, a lawsuit was filed in federal court in San Diego seeking $5 million against 23andMe, claiming its PGS advertised medical claims without getting appropriate FDA authorization.

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