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Wednesday, January 04, 2023 9:26:24 AM
So, yesterday I sent an email to druginfo@fda.hhs.gov asking them to look into blatant violation of the patent and exclusivity rights for VASCEPA as evidenced by fepBlue's Claim form where they said they would cover VASCEPA ONLY after "trying and failing" their listed alternatives, (Lovaza, GV). What constitutes "failure"? DEATH? Heart Attack? Stroke? BTW I posed this same question to @fepBlue on Twitter.
Here's the response I got back from the FDA:
Dear Sir or Madam,
Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
We understand that the cost of drugs has a direct impact on the ability of people to cope with their illnesses, as well as meet other expenses.
Please understand that the FDA does not control which drugs insurance companies may cover or to what extent a drug may be covered. Insurance companies may create policies that follow the FDA-approved product labeling (also known as the prescribing information). The labeling of each product contains the FDA-approved indications for use, dosage and administration recommendations, and important safety information such as boxed warnings, contraindications, side effects, and warnings and precautions.
If you disagree with a determination by your health plan, we recommend working with the health plan directly to understand that basis for the determination and how to file an appeal, if applicable. You may also need to enlist the help of your health care provider if you file an appeal or if you need to seek an alternative drug covered by your plan.
There is government oversight of health plan practices. To file a complaint about health plan practices, contact the State Insurance Commissioner’s office, the State Attorney General’s office, or the Consumer Affairs office. The correct title of the appropriate office can differ by state. You can visit the U.S. Department of Labor web page for additional information.
Best regards,
TNC
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
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