Frequently asked questions

Medical information

How do I request information about Seagen medicines or programs?

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Healthcare professionals, patients, and caregivers may request specific product and/or program information from Seagen Medical Information.

Phone

Global: 1-855-4SEAGEN (1-855-473-2436)

Canada: 1-833-4SEAGEN (1-833-473-2436)

Contact information for European residents

Email

medinfo@seagen.com

For healthcare professionals

Medical Information Portal

How do I report a side effect?

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Patient safety is of the utmost importance to Seagen. To provide better safety information for our medicines, we monitor side effects continuously in clinical trials and after bringing a therapy to market. Please report any side effects caused by Seagen medicines. We may contact you for more information concerning your report.

Seagen is unable to provide medical advice. If you are a patient and are concerned in any way about your treatment, you should contact your healthcare professional.

To report a safety concern, please contact drug.safety@seagen.com

In the United States, you can also contact MedWatch, the FDA Safety Information and Adverse Event Reporting Program at 1-800-332-1088 or www.fda.gov/Safety/MedWatch.

How do I report a product complaint?

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Seagen is committed to producing to the highest possible standards. If you have any concerns about the identity, quality, reliability, safety, effectiveness, or performance of a Seagen product, please report them immediately.

To report a product complaint, please email us at productqualitycomplaints@seagen.com

In the United States, you can also contact MedWatch, the FDA Safety Information and Adverse Event Reporting Program at 1-800-332-1088 or www.fda.gov/Safety/MedWatch.


Compliance

The National Physician Payment Transparency Program (Open Payments/Sunshine Act), is a section of the Patient Protection and Affordable Care Act of 2010. It requires pharmaceutical companies, medical device companies, and group purchasing organizations to report certain payments made to U.S. licensed physicians and teaching hospitals to the Federal government. The Open Payments Act aims to create greater transparency around these financial relationships.

In 2018, Congress enacted the SUPPORT Act, which included expanding the list of Open Payments covered recipients to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. Transfer of value and payment collection for the additional recipients is effective January 1, 2021 for reports to be published in 2022.

Who are the covered recipients under the Open Payments Act?

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From the year 2013 to 2020, Seagen is required to report payments or other transfers of value made to U.S. licensed physicians and teaching hospitals, as is defined on an annual basis by the Centers for Medicare and Medicaid Services (CMS). Beginning January 1, 2021, Seagen will be required to also report on physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

What types of payments and transfers of value are reported under the Open Payments Act?

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Seagen must report payments and transfers of value that include the cost of meals, as well as payments that are part of a contracted service such as speaker programs, advisory boards, consulting, and clinical trials. In addition to meals and payments, Seagen must report other transfers of value including, but not limited to, travel, educational items (including reprints), stocks, and grants. Also reportable are expenses covered or reimbursed, such as hotel and travel.

When are the payments and transfers of values reported?

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Payments and other transfers of value are reported on a calendar year basis, from January 1 to December 31 of the reporting year. Seagen reports all payments and other transfers of value of the preceding year to CMS on or before March 31 on an annual basis.

Can I see the information Seagen provides to the government before it is published to the public?

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CMS will post information provided by Seagen on the CMS website and provide 45 days for review by physicians and teaching hospitals. The manufacturer will then have 15 days to address any physician concern about his or her data before final posting on the CMS website.

Where will the payment information be posted?

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Open Payments requires that CMS make reported payments available on the Open Payments website. Open Payments regulations do not require companies to publish payments on their own websites

Does Open Payments apply to nurses and office staff?

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Due to the SUPPORT Act of 2018, meals and items of value provided to some nurses (nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives) are reportable. Office staff is not reportable under the Open Payments Act. However, some state marketing disclosure and transparency laws require disclosure of payments to a broader group of recipients, including non-physician prescribers, nurses, and office staff.

If my contract with Seagen is through my institution, will my name be disclosed?

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If the contract for services is with your institution, and that institution is a reportable teaching hospital, then the fee will be reported under your institution’s name rather than yours, except for trials in which case both the institution name and the primary investigator information will be reported. If you request that we pay another entity, such as your LLC or a charity, for a contracted service instead of you personally, Open Payments regulations require that we report the fee under your name and list the entity paid as a third-party recipient on the same line item. Keep in mind that any expenses covered or reimbursed as part of your contract, such as travel and lodging expenses, will be reported under your name. If you have a question about a specific contract, please contact Seagen at aggspend@seagen.com.

If the payment comes from a third-party vendor rather than Seagen, is the payment still reportable?

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Yes, if you are paid by a third-party vendor for work that is conducted on behalf of Seagen, Seagen must report your fee and any other transfers of value you receive, including travel and meals.

What will be reported for company-sponsored trials and investigator-sponsored trials?

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For either type of trial, payments to the sites, including any drug provided, will be reported for the principal investigator and their institution.

Do I need to pay taxes on items of value reported?

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Tax matters are not addressed by Open Payments and Seagen has no visibility into whether there will be tax implications.

How does Open Payments relate to state disclosure laws?

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Open Payments regulations do not replace state laws. Any meal or spending prohibitions that exist in your state remain in place, and any state can add such prohibitions in the future. Open Payments requirements will preempt some similar state reporting requirements, but Seagen currently plans to continue reporting all required spend to these states. State laws requiring explicit disclosure currently exist in Connecticut, Massachusetts, Minnesota, Nevada, Vermont, and Washington, D.C.