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Coalition Files Citizen Petition to Stop 'Unlawful' FDA Actions Against PGx Testing

NEW YORK –  A coalition of labs providing pharmacogenetic testing, software companies that enable such testing, and doctors using tests in patient care have filed a citizen petition asking the US Food and Drug Administration to stop its oversight attempts to limit these services. 

The members of the Coalition to Preserve Access to Pharmacogenomics said that if the FDA wants to regulate PGx tests, it must advance future policies regarding PGx testing by following the Administrative Procedure Act, which calls for notice-and-comment rulemaking.

"We filed the citizen petition because FDA's actions are problematic in multiple respects," said Jeff Gibbs, a director at the law firm Hyman, Phelps & McNamara with expetise in FDA regulation. Hyman, Phelps & McNamara submitted the petition on behalf of the labs and companies in the coalition, which have chosen to remain anonymous out of concern that they may face additional regulatory repercussions.

"Restricting the flow of pharmacogenomic information to physicians runs counter to FDA's avowed goal of promoting personalized medicine and harms, not helps, patient care," Gibbs said. "FDA's restrictions also violate the Administrative Procedure Act, raise significant First Amendment issues, and have caused significant confusion for laboratories, software providers, and doctors."

Starting in the fall of 2018 and through 2019, the FDA turned its oversight attention on labs providing PGx testing without its approval or clearance. The agency issued a safety communication in November 2018 cautioning doctors and patients that most genetic tests claiming to predict a patient's response to specific drugs haven't been reviewed by the FDA, and that doctors could end up harming their patients by using such tests to make treatment decisions.

Then, in April 2019, the agency sent a warning letter to Inova Health System's genomics lab in Virginia for marketing its MediMap test without approval. Subsequently, the health system stopped providing PGx testing entirely.  

During this time, the agency also reached out to labs, many of which are members of the Coalition to Preserve Access to Pharmacogenomics, and in private communications told them to stop mentioning drugs in PGx test reports until those tests have been reviewed and authorized by the FDA for marketing. In their petition, coalition members said that software companies that generate PGx reports for labs also heard from the FDA. 

"In these communications, FDA officials did not distinguish between medications whose FDA-approved labeling included information about PGx interactions and those that did not," according to the petition. "Rather, companies were directed to remove all drug information even if it was derived directly from FDA-approved drug labeling." 

Additionally, the coalition alleges that the agency has also told labs that they couldn't inform doctors of clinical guidelines that discussed how PGx test results might impact specific medications that patients' might receive. This would restrict labs from referencing in test reports widely accepted PGx guidelines from the Clinical Pharmacogenetics Implementation Consortium, for example.

The FDA has updated the labels of close to 400 drugs with PGx information, but the agency hasn't kept pace with new evidence as it has emerged in the literature, the coalition members charged in their petition. They cited the example of the depression drug citalopram (Allergan's Celexa), for which the FDA updated labeling in 2011, but hasn't added more recent information about ultra-rapid metabolizers, despite evidence in the literature. 

The coalition members argued that the FDA's attempts to restrict PGx tests are actually counter to its mission to protect the public health. Without access to PGx information, doctors may end up prescribing treatment that cause patients to have a fatal adverse event, they said. 

Similarly, the National Alliance on Mental Illness, National Council for Behavioral Health, the Depression and Bipolar Support Alliance, and Mental Health America jointly wrote to the FDA last year that the agency's actions restricting labs from mentioning drugs in lab reports "may in fact inflict greater harm on patients."

The agency's manner in communicating with labs has caused much confusion in the Industry due to a lack of enforcement consistency. The agency, for example, reached out to some labs which resulted in them having to remove all mention of drugs from test reports, while other labs marketing tests without FDA approval have not been made to remove references to drugs from reports.

In these discussions with labs, furthermore, agency officials didn't cite any specific regulations the labs had violated by communicating PGx information to providers, according to the petition. As such, the members of the coalition asserted in their petition that the agency's actions are unlawful and suppress protected speech about the role of PGx informing patients' ability to metabolize and respond to certain drugs. 

The American Clinical Laboratory Association has also written to the agency challenging its authority to regulate lab-developed tests, and pointed out that the agency should continue to work with stakeholder to advance a new regulatory framework for all in vitro clinical tests, as it has promised to do.

In the petition, the members are specifically asking the agency to issue a revised safety communication, clarifying that labs and software firms can communicate information about gene-drug interactions when supported by "adequate evidence" and isn't restricted by FDA drug labeling. 

Additionally, the coalition members assert that by restricting labs' ability to communicate gene-drug relationships in test reports, the FDA is encroaching on their First Amendment rights and violating the Federal Food, Drug, and Cosmetic Act's restriction on regulatory activities that limit or interfere with a healthcare provider's ability to practice medicine.  

"[The] FDA should permit clinical laboratories to include medication-specific information in PGx test reports that is (1) included in FDA-approved drug labels or (2) that is supported by adequate evidence of PGx gene-drug associations without clearance or approval of a premarket submission," the members wrote. 

Citizen petitions are a mechanism by which members of the public can request the FDA to change its policies. The agency, by law, must eventually respond to them. Further, it opens a public docket where other interested parties may weigh in, creating a public record. Stakeholders have used the mechanism to challenge the FDA's regulation of laboratory tests in the past. 

Hyman, Phelps & McNamara used the mechanism in 1992 to challenge FDA's authority to regulate assays developed in clinical reference labs, to which the agency responded years later by defending its authority. The Washington Legal Foundation in 2006 also submitted a petition to FDA requesting the agency not regulate lab tests, and Hyman, Phelps & McNamara submitted comments supporting the petition. And in 2008, Genentech, petitioned the agency, asking it to more consistently regulate all lab tests, instead of extending its oversight in a piecemeal fashion.

These attempts have not thwarted FDA's attempts to try to regulate LDTs for more than two decades, during which time the agency has maintained that it has oversight authority under the law. In the present debate, the agency may be open to discussing the topic of PGx regulation with stakeholders. Last December, in a policy meeting held by the Personalized Medicine Coalition — which wasn't open to members of press but is referenced in the citizen petition — Timothy Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health discussed the agency's communications to labs offering PGx testing, and recommended the formation of a "collaborative community" focused on this issue.  

It's not clear which organization would lead the formation of such a community, which groups would be included, and whether the discussions would be public. The Coalition to Preserve Access to Pharmacogenomics isn't satisfied this would address its concerns, and are asking the agency to convene a public hearing. "This is a matter pending before FDA and a hearing is in the public interest," the group said.