Regulatory Focus™ > News Articles > 2020 > 1 > Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

Posted 14 January 2020 | By Michael Mezher 

Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

Law firm Hyman, Phelps & McNamara (HP&M) last week filed a citizen petition on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information, requesting that the US Food and Drug Administration (FDA) allow laboratories to provide gene-drug interaction information in genetic test reports.
The petition comes after FDA in 2018 and 2019 took action to crack down on unapproved genetic tests that offered gene-drug interaction information either directly to consumers or to patients via their physicians. In 2018, FDA issued a safety communication and statement advising that “clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.”
Then, in April 2019, the agency warned Virginia-based Inova Genomics Laboratory over its MediMap tests for predicting medication response after the company declined to remove claims regarding drug response information from labeling and promotional materials. The company had previously argued that its tests are laboratory developed tests (LDTs) and are not subject to premarket review or labeling requirements.
However, FDA challenged Inova’s claims, pointing out that it had “not created a legal ‘carve out’ for LDTs such that they are not required to comply with the requirements under the [Food, Drug, And Cosmetic Act (FD&C Act)] that would otherwise apply.”
These actions come after years of debate over how FDA should regulate LTDs and in vitro clinical tests (IVCTs) and delays from the agency in issuing guidance on the matter.
In addition to FDA’s statements and warning letter to Inova, HP&M says that FDA privately directed “a number of clinical laboratories … to cease including information about specific medications in laboratory reports for PGx tests unless and until such tests have been authorized by FDA in the context of a premarket submission.”
The petition also claims that FDA gave similar directions to software companies that provided services related to PGx tests, instructing them “to remove all drug information [from the reports] even if it was derived directly from FDA-approved labeling.”
HP&M notes that there are “currently 385 known gene-drug interactions in FDA approved prescribing information for hundreds of drugs,” with some labeling providing specific instructions based on biomarker information.
However, at issue for FDA is whether the information provided by the tests has been clinically validated, as inaccurate information could lead to patients or physicians making treatment decisions based on unsound information.
FDA points out that “there are some drugs whose use can be aided by the results of pharmacogenomic information. In those cases, there is scientific evidence to support relationships between the genetic variant and how a patient responds to a drug, which has been reviewed by the FDA.” FDA also notes that some PGx tests have claimed to provide information on the effectiveness and side effects of different antidepressants based on genetic markers, even though such relationships have “never been established.”
In the petition, HP&M calls on FDA to reverse course and issue a revised safety communication stating that test makers and software companies “may communicate information about gene-drug interactions as part of genetic test reports to the extent such information is supported by adequate evidence and is not contraindicated by information in drug labels with PGx information.”
The firm argues that such communication is permitted under the First Amendment and the practice of medicine clause of the FD&C Act.
The citizen petition also calls on FDA to conduct any future policymaking through notice and comment rulemaking in line with the Administrative Procedure Act and requests that the agency hold a public hearing on matter.
Citizen Petition


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