diagnostics-1
26 November 2013Americas

FDA orders 23andMe to cease PGS sales

The US Food and Drug Administration (FDA) has told genetics company 23andMe to stop selling its Personal Genome Service (PGS) product immediately.

FDA director Alberto Gutierrez wrote to the company on November 22 to say that the product, which the agency defines as a medical device, is being marketed without approval.

In a statement on its website, 23andMe said it had received the letter and recognised that “we have not met the FDA’s expectations regarding timeline and communication regarding our submission” and that “we are committed to fully engaging with them [the FDA] to address their concerns”.

Gutierrez, addressing 23andMe’s chief executive Ann Wojcicki, said the PGS meets the “medical device” criteria under the Food, Drug and Cosmetic Act, as it is intended to help diagnose or treat diseases. Conditions listed on the company’s website include diabetes and breast cancer.

But most of the intended uses have not been classified, Gutierrez claimed, and therefore require approval, while some of the uses are “particularly concerning”. These include the assessments for BRCA-related genetic risk and drug responses, which could cause worrying health consequences if not administered correctly.

“For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions,” Gutierrez said.

The FDA has told 23andMe on “numerous occasions” about the need to approve the PGS, including after the company submitted two pre-marketing notifications – 510(k)s – in June and September 2012.

“Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorisation for your PGS device,” he said.

But after “many” interactions with 23andMe, the FDA still does not have “any assurance” that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses identified in the firm’s submissions, Gutierrez explained.

“Instead,” he added, “we have become aware that you have initiated new marketing campaigns, including television commercials that ... show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”

If the company fails to adequately address the FDA’s concerns, Gutierrez noted, the agency can take action including seizures, injunctions and fines.

The agency’s concerns raise interesting questions about the future of genetic testing, said Kevin Noonan, partner at McDonnell, Boehnen, Hulbert & Berghoff LLP, particularly under circumstances where the Supreme Court has raised significant barriers to obtaining patent protection for these types of testing.

“In such an environment there may be a much lower impetus for disclosing the ‘natural law’ correlations between disease propensity and genetic variability, because once that disclosure is made it cannot be retracted. If patent exclusivity is not possible, there could easily arise a ‘tragedy of the commons’, where no company is motivated to undertake the type of efforts demanded by the agency of 23andMe, just to have those efforts co-opted by its competitors.

“In this situation, the agency may be required to permit applicants to keep substantial portions of their submissions confidential and be satisfied by a showing that the correlation between a particular genetic variant and a particular disease is sufficiently robust to justify approval,” he said.

Even if the agency were willing to permit nondisclosure for a time, Noonan said, it is unlikely to agree to less than a reasonable term, for example 20 years from the date the application was submitted for approval.

“Thus it could be that in such a roundabout way agency action could achieve what the patent system has always provided, but perhaps in a form less amenable to meddling from the court.”


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Americas
27 July 2018   GSK revealed its new approach to research and development earlier this week, including a partnership with DNA testing company 23andMe.

More on this story

Americas
27 July 2018   GSK revealed its new approach to research and development earlier this week, including a partnership with DNA testing company 23andMe.