It sounds like you’re looking to get Vascepa reviewed or approved more quickly, but it would help to know which “application” you’re referring to. There are a few possibilities:
| What you might mean | Where it happens | Typical ways to speed it up |
|---------------------|------------------|-----------------------------|
| New‑drug (or supplemental) application to the FDA (NDA, BLA, etc.) | FDA, Office of New Drugs (OND) | Fast Track (for diseases with unmet needs), Breakthrough Therapy, Accelerated Approval, Priority Review (first 30 days). The sponsor must submit a request and meet specific criteria. |
| Insurance or pharmacy benefit authorization for a patient | Your health‑plan or pharmacy benefits manager | Appeal the denial, request “prior authorization” or “expedited review.” The provider (often the prescribing physician or pharmacist) usually files the appeal. |
| Clinical trial or IND application | FDA, Investigational New Drug (IND) Office | Request an Expedited IND review if the trial involves a serious condition and the data are promising. |
| Regulatory clearance for a new indication | FDA | Submit a Supplemental NDA or Abbreviated New Drug Application (ANDA) and request Fast Track or Accelerated Approval. |
Quick pointers
1. If you’re a drug sponsor (company, research institution, etc.)
* Fast Track: Submit a Fast Track designation request. The FDA will review whether the drug meets the criteria (serious condition, unmet medical need, promising data).
* Priority Review: After FDA grants Fast Track, you can request Priority Review, which aims to cut the review time from 10 months to about 6 months.
* Breakthrough Therapy: Requires the drug to show substantial improvement over existing therapies on one or more clinically significant endpoints.
* Accelerated Approval: If early‑stage data (e.g., surrogate endpoints) suggest meaningful benefit, the FDA can approve on that basis and require post‑marketing studies.
These pathways are not guaranteed, and the FDA makes the final decision. The application must be complete, the data robust, and the requested designation justified.
2. If you’re a prescriber or patient
* Ask your healthcare provider to request Fast Track or Priority Review on your behalf (if they are a sponsor or are submitting a new application).
* For insurance coverage, the provider can file a prior‑authorization appeal or an “expedited review” request, usually citing medical necessity and relevant evidence.
* Keep copies of all documentation and follow the insurer’s appeal timeline.
3. If you’re a researcher
* For INDs, the FDA offers Expedited IND review for serious or life‑threatening diseases.
* For clinical trials, the Fast Track designation can also apply to trial protocols.
Next steps
* Clarify the application type – Is this a drug approval request to the FDA, an insurance claim, or something else?
* Gather the necessary documentation – For FDA pathways, you’ll need clinical data, disease‑state justification, and a clear indication that the drug addresses an unmet need.
* Contact the relevant office – For FDA submissions, reach out to the Office of New Drugs or the specific center handling your product (e.g., Center for Drug Evaluation and Research, CDER). For insurance matters, contact the benefits manager or use the insurer’s online portal.
Let me know which scenario fits your situation, and I can walk you through the exact steps or help you draft a request.