Pharmacogenomic testing marketing: claim rules

Pharmacogenomic testing, also called PGx or pharmacogenetic testing, looks at genes that can affect how a person responds to a medicine. It is offered by psychiatry and primary care practices, pharmacies, telehealth services and labs that sell directly to consumers or market to clinicians. The idea is easy to sell: a cheek swab that tells you which medicine will work. The federal sources say something narrower. FDA lists gene and drug pairs and says for which of them the data support a therapeutic management recommendation, has warned that test claims to predict medication response can go beyond the evidence, and tells patients not to change their medicines on their own. Marketing for these tests has to stay inside that narrower message, keep the prescriber in charge of every medication decision, and avoid the referral arrangements federal law treats as kickbacks.

Two related topics have their own guides and are not repeated here. Genetic test types, privacy promises, consent and GINA wording are covered in our genetic testing marketing guide. Tests sold online without a clinic visit are covered in our direct-to-consumer lab testing marketing guide. This guide covers what is specific to pharmacogenomic tests.

This is general information, not legal or medical advice. Medication decisions belong to the patient’s prescriber. Sources cited were checked on October 30, 2026: the FDA Table of Pharmacogenetic Associations (content current as of September 10, 2026), the FDA safety communication on genetic tests with unapproved claims to predict patient response to specific medications (issued October 31, 2018, now in FDA’s archive), the MedlinePlus pages Pharmacogenetic Tests (last updated August 7, 2025) and What is pharmacogenomics? (last updated March 22, 2022), the Medicare local coverage determination MolDX: Pharmacogenomics Testing (L38294, revision effective October 2, 2025), 42 CFR 410.32, the HHS OIG Fraud Alert: Genetic Testing Scam (last updated September 27, 2019), 42 U.S.C. 1320a-7b, 18 U.S.C. 220 and 24, 15 U.S.C. 45 and 52, the FTC Health Products Compliance Guidance, 16 CFR 255.2, 45 CFR 164.508 and the Google Ads healthcare and restricted targeting policies.

What FDA says the evidence supports

FDA keeps a Table of Pharmacogenetic Associations. The page says that when a health care provider is considering prescribing a drug, knowledge of a patient’s genotype may be used to aid in choosing a therapeutic strategy, choosing a dosage, or assessing the likelihood of benefit or toxicity. It sorts the listed gene and drug pairs into three sections: those where the data support therapeutic management recommendations, those where the data indicate a potential impact on safety or response, and those where the data show a potential impact on drug levels only.

The same page sets clear limits that belong in any marketing for these tests. It says inclusion of a gene and drug pair in the table does not necessarily mean FDA advocates using a pharmacogenetic test before prescribing the medicine, unless the test is a companion diagnostic. It says the large majority of the listed associations have not been evaluated for the impact of genetic testing on clinical outcomes, such as better effectiveness or fewer adverse events. It says each patient’s genetic makeup is only one of several factors that may affect drug levels and response, that the table is intended primarily for prescribers, and that patients should not adjust their medications without consulting their prescriber.

The MedlinePlus page Pharmacogenetic Tests gives readers the same balanced picture. It says providers consider personal and family history, lifestyle and environment, and other medicines and supplements before choosing a medicine, and that pharmacogenetic tests are not available for all medicines or used for all health conditions. The MedlinePlus Genetics page What is pharmacogenomics? describes the field as growing, with new approaches under study in clinical trials.

The FDA warning about unsupported test claims

In 2018 FDA issued a safety communication, a warning against the use of genetic tests with unapproved claims to predict patient response to specific medications, which now sits in FDA’s archive. It said claims for a large number of genetic tests to predict a patient’s response to specific medications had not been reviewed by FDA and may not have the scientific or clinical evidence to support that use for the large majority of medications. It said changing drug treatment based on such a test could lead to inappropriate treatment decisions and potentially serious health consequences.

The communication described the kinds of claims FDA had seen: tests offered through providers or directly to consumers that claim to predict which medication should be used, or that a medication may be less effective or have more side effects, for conditions such as depression, heart conditions and acid reflux. It also named software that interprets genetic data from another source to make the same kind of claim. Its advice to patients was direct: do not change or stop taking any medicine based on a report from a genetic test you took on your own, and discuss the results with your health care provider. Its advice to providers was to check the FDA-approved drug label, or the label of an FDA-cleared or approved test, for whether genetic information should be used in treatment decisions.

Because the communication dates from 2018 and the table has been updated since, a practice should not repeat statements from either about a particular drug class without checking the current table and the current drug label. Keep drug names and gene and drug pairings out of marketing copy, and leave them to the clinician’s conversation with the patient.

Claims that need rewriting

Under 15 U.S.C. 45, deceptive acts or practices in commerce are unlawful, and 15 U.S.C. 52 prohibits false advertisements likely to induce the purchase of drugs, devices or services. The FTC staff Health Products Compliance Guidance says claims about the health benefits or safety of health-related products require competent and reliable scientific evidence. Set against the FDA sources above, several phrases seen in PGx marketing do not hold up.

Phrases that need rewriting:

“Find the right medication the first time” or “know which medicine will work”. FDA says genotype is one of several factors and that the table is for prescribers. Write “A pharmacogenomic test can give your prescriber information about how your body may process certain medicines. Your prescriber weighs it alongside your history and other factors.”
“End trial and error” or “no more side effects”. FDA says the large majority of listed associations have not been evaluated for their effect on clinical outcomes, and its 2018 communication warned against unsupported predictions of response.
“Tells you which antidepressant to take” or any similar promise for one drug class. FDA’s 2018 communication addressed this kind of claim directly. Describe the test, not a treatment choice.
“Bring your results and we will change your medicine”. A test result is an input for the prescriber, who decides whether anything changes.
“FDA-approved test” or “FDA-backed” for a test that has not been cleared or approved for the claim you make, or wording that suggests inclusion in the FDA table is an endorsement of testing. The FDA page says it is not.
“One test for life” or “covers every medicine”. MedlinePlus says these tests are not available for all medicines or used for all conditions.

Keep the prescriber in charge

One line on a PGx page comes straight from FDA: patients should not adjust their medications without consulting their prescriber. Put it near the top of the test page, in the results email and in any report a patient can download. A pharmacy or a lab that is not the patient’s prescriber should say plainly that it will share the result with the patient and, with the patient’s permission, with their prescriber, and that only the prescriber can decide whether to change a medicine or a dose.

Wording that keeps the prescriber in charge:

“Do not stop or change any medicine because of this result. Talk with the clinician who prescribes it.”
“This test looks at a limited set of genes linked to how certain medicines are processed. It does not cover every medicine and it does not diagnose a condition.”
“Your prescriber will consider this result along with your medical history, other medicines and your preferences.”
“If you are in crisis or thinking about harming yourself, call or text 988.” Pages about mental health medicines should carry this line.

Psychiatric practices that offer testing should also follow our psychiatric practice marketing guide, and pharmacies our independent pharmacy marketing guide.

Medicare coverage, stated carefully

Medicare coverage of pharmacogenomic testing is set through local coverage determinations, and the wording on a marketing page should not go further than the policy does. The local coverage determination MolDX: Pharmacogenomics Testing (L38294) describes itself as a limited coverage policy. It says testing is reasonable and necessary only in limited circumstances, once a treating clinician has narrowed treatment to specific medications under consideration, or is already using a medication, and when the drug has a gene and drug interaction shown to be clinically actionable as described in the policy. It says the selection of the medications must come from clinical factors rather than from a PGx test, and that testing is not considered reasonable and necessary merely on the basis of a patient having a particular diagnosis.

Separately, 42 CFR 410.32(a) says diagnostic laboratory tests must be ordered by the physician who is treating the beneficiary and who uses the results in managing the beneficiary’s specific medical problem, and that tests not ordered by that physician are not reasonable and necessary. Coverage policies differ by Medicare contractor and change over time, and commercial plans set their own rules.

For marketing, that means:

Do not advertise “covered by Medicare” or “free with Medicare”. Say coverage depends on the plan and on the clinical situation, and that the practice or lab will check before testing.
Do not market testing to people on the basis of a diagnosis alone, such as a campaign that offers a test to anyone with depression. The policy says a diagnosis alone does not make the test reasonable and necessary.
Do not offer testing that skips the treating clinician. Under 42 CFR 410.32(a), the treating physician orders the test.
State any self-pay option clearly, in writing, before the sample is taken.

Referral arrangements, kickbacks and lab law

PGx testing has drawn federal fraud attention. The HHS OIG Fraud Alert: Genetic Testing Scam describes scammers offering Medicare beneficiaries free cheek swabs or screenings through telemarketing calls, booths at public events, health fairs and door-to-door visits, in order to obtain Medicare information for identity theft or fraudulent billing. It tells beneficiaries that a physician they know and trust should assess their condition and approve any genetic testing. A legitimate practice should make sure none of its marketing looks like this: no unsolicited calls offering free tests, no health fair swab booths, no requests for Medicare numbers before a clinician is involved.

Two federal laws shape how labs, practices and marketers can be paid. The federal anti-kickback statute, 42 U.S.C. 1320a-7b(b), makes it a felony to knowingly and willfully offer, pay, solicit or receive any remuneration to induce or reward referrals of items or services paid for by a federal health care program. The Eliminating Kickbacks in Recovery Act, 18 U.S.C. 220, makes it a crime to knowingly and willfully pay or receive remuneration for referring a patient to a laboratory, or in exchange for an individual using a laboratory’s services, for services covered by a health care benefit program. Under 18 U.S.C. 24(b), that term means any public or private plan or contract under which a medical benefit is provided, so the lab law is not limited to federal programs. Both statutes have exceptions, and 18 U.S.C. 220 limits its employee exception to pay that does not vary by the number of individuals referred, the number of tests performed or the amount billed.

Arrangements to take to counsel before signing:

A marketer, recruiter or call center paid per sample, per test or per patient for PGx testing.
A lab that offers a practice payment, staff, free equipment or a share of revenue linked to the tests the practice orders.
Sales staff whose pay rises with the number of tests ordered or the amount billed.
Free testing offered to patients when the lab bills an insurer.

Our clinical lab marketing to physicians guide and our guide to patient and physician referrals cover these rules for labs and practices in more detail.

Patient stories, tracking and ads

A patient story about testing can easily imply that the test found the right medicine. Under 16 CFR 255.2, an advertisement that uses a consumer endorsement about a key attribute of a service is likely to be read as representing that the endorser’s experience is representative, unless the advertiser has substantiation for that or clearly and conspicuously discloses what people can generally expect. A story about a medication change credits the test with what was a prescriber’s decision. If you use stories, keep them about the experience of testing and talking with the prescriber, get a signed authorization under 45 CFR 164.508 where the practice is a covered entity, and say that results vary.

Medication lists, test results and questionnaires about current medicines are health information. Keep them out of advertising and analytics tools unless you have checked what each tool receives and what your agreements with it cover, as our guide to tracking pixels on practice websites explains.

For ads, the Google Ads healthcare and medicines policy says Google restricts the use of prescription drug terms in ads, landing pages and keywords, so naming medicines in a PGx campaign may be limited or not allowed depending on the location. The restricted targeting policy for personalized advertising lists health among its sensitive interest categories, so audiences cannot be built around a person’s condition or the medicines they take. Our healthcare ad policy basics guide covers the wider policy.

Illustration: two ads for the same test

Illustration: an ad reads “Stop guessing. One cheek swab finds the antidepressant that works for you. Covered by Medicare. Bring us your results and we will switch your prescription.” It promises a treatment choice FDA warned such tests cannot support, names a drug class FDA addressed directly, overstates coverage, and invites a medication change outside the prescriber relationship.

Illustration: a second ad for the same practice reads “Pharmacogenomic testing at [Practice name]. A test that can give your prescriber information about how your body may process certain medicines. Ordered and reviewed by a [license type]. Coverage depends on your plan; we check first.” The landing page links to the FDA table and MedlinePlus, says the test does not cover every medicine, tells readers not to change any medicine on their own, and carries the 988 line on mental health pages.

Checklist before a PGx testing campaign goes live

No page promises the right medication, an end to trial and error or no side effects.
Every test page and results message says not to change or stop a medicine without the prescriber.
No drug names, drug classes tied to outcomes, or gene and drug pairings appear in ads or headlines.
Any statement about FDA status matches the test’s actual clearance or approval and does not present the FDA table as an endorsement.
The page says the test does not cover every medicine or condition, with links to FDA and MedlinePlus.
Coverage wording says it depends on the plan and clinical situation; no “covered by Medicare” or “free” claims.
Testing is ordered by the treating clinician, and no campaign offers testing based on a diagnosis alone.
No marketer, recruiter, call center or staff member is paid per sample, per test or by amount billed without counsel’s review under 42 U.S.C. 1320a-7b(b) and 18 U.S.C. 220.
No unsolicited calls, health fair swab booths or requests for Medicare numbers before a clinician is involved.
Medication questionnaires and results stay out of ad and analytics tools, and ads do not target by health condition.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a practice or pharmacy that offers pharmacogenomic testing, that means test pages that describe what the test can and cannot show with links to FDA and MedlinePlus, ads that do not promise a treatment choice, and inquiry forms that keep medication details away from tracking tools. We do not decide which tests are offered, how results are used or whether a payment arrangement is lawful; your clinicians, your counsel and your state’s rules do. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We are not a healthcare provider and we do not give legal or medical advice. We do not sell lead lists and we do not pay for referrals. For the wider rules, see our healthcare marketing rules hub.

Can we say a pharmacogenomic test finds the right medication?

No. FDA says genotype is only one of several factors in drug response, that its table of associations is intended primarily for prescribers, and that the large majority of listed associations have not been evaluated for their effect on clinical outcomes. Describe the test as information for the prescriber.

What should a PGx test page tell patients about their medicines?

FDA says patients should not adjust their medications without consulting their prescriber, and its 2018 safety communication told patients not to change or stop any medicine based on a genetic test they took on their own. Put that line on the test page and in every results message.

Does inclusion in the FDA table mean FDA recommends testing?

No. The FDA page says inclusion of a gene and drug pair does not necessarily mean FDA advocates using a pharmacogenetic test before prescribing the medicine, unless the test is a companion diagnostic.

Can we advertise that Medicare covers the test?

Medicare coverage depends on the local coverage policy and the clinical situation. The MolDX policy describes limited coverage once a treating clinician is considering specific medications with actionable gene and drug interactions, and says a diagnosis alone is not enough. Say coverage depends on the plan and check before testing.

Can we pay a marketer per test for PGx referrals?

That kind of arrangement can raise issues under the federal anti-kickback statute and 18 U.S.C. 220, which covers referrals to laboratories under public and private plans. Have counsel review any payment tied to samples, tests or amounts billed before you sign.

Can we run Google Ads for pharmacogenomic testing?

Google restricts prescription drug terms in ads, landing pages and keywords, and its restricted targeting policy does not allow audiences built on health conditions. Keep medicine names out of ads and use keyword and location targeting with an honest landing page.

Sources

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Pharmacogenomic testing marketing: FDA claims, prescriber wording, Medicare coverage and referral rules