Amarin Corp Plc (AMRN)

[MedResCollab]

“Noeructation” (these handles!) and also to north40000,

NoE, we agree, you’ve outlined that well. And we are sure you are mindful that there are prescription vitamins with equivalent dietary supplements, for instance vitamin D. Are you really that much better off getting a prescription vitamin D supplement vs a vitamin D dietary supplement? We aren’t talking about dangerous APIs here. We’re talking about refined fish oil.

What does FDA actually do to regulate drug products like Vascepa, and does that make Vacsepa safer than/better than products like OmegaVia? FDA has a risk-assessment approach to surveillance of drug manufacturing facilities to ensure they are operating under CGMP guidelines. For a product like Vascepa, with a very low risk profile, and overseas facilities, they probably have only gotten one or at most two abbreviated inspections since 2012. These inspections almost never actually take test sample of the product and run CoAs. They are examining the facility itself, the equipment, health and safety standards of the workers, and other various compliance measures. The FDA runs a full inspection pre approval, but once things are running with no major unprompted issues being alerted to them, they don’t look very often, and when they do, they don’t look very hard. And again, no certificates of analysis (CoAs) unless for very good reason.

Okay so if workers aren’t wearing appropriate attire, or condensation is leaking into a batch, or paint is peeling on multiple walls, or equipment is past due on maintenance, they issue a warning to get those items resolved, and check back to make sure they are, and then they’re off and running.

In one sense these regulations can be a hinderance to drug innovation because if there is new tech or process discovered and you want to adopt the change to make it better, you have to go through hoops. So drug companies most often keep the same old process and formulas without any changes for sometimes 20+ years.

A company like OmegaVia runs CoAs all the time, and has its product produced in facilities that are also FDA CGMP compliant. For example, as per these FAQs:

Is OmegaVia made in China?

No. No part of the product is made in China.
Softgel encapsulation and packaging is in California (USA) under stringent FDA approved conditions

Is it IFOS tested and 5-star certified?

Yes, OmegaVia is tested at IFOS. All data, including Omega-3 and mercury content are tested three times after the oil has been put into the capsule.

First test is in our internal lab. Second test is at an FDA-approved third-party lab. Third test is at IFOS.
We also test for purity and cleanliness before the oil is encapsulated.

Is the product FDA certified?

FDA does not certify supplements because supplements provide nutrients that are already present in our foods.
FDA has inspected the facility and equipment used to make OmegaVia.
OmegaVia is manufactured and packaged in a facility that has the following quality certifications:
FDA-certified for Good Manufacturing Practices (cGMP).
NSF-certified and registered for Good Manufacturing Practices.
Organic-certified by NAI.

https://omegavia.com/faq/

Vascepa is not put under the wringer like OmegaVia is, because Amarin is not required to. OmegaVia has to compete in the marketplace, and part of what makes them competitive in ensuring they have one of the highest quality products on the market.

Is OmegaVia really produced in less stringent conditions than Vascepa? No, no evidence of that. Is the quantity of EPA stated on the labels of both products accurate? Are both products below USP-NF limits set for peroxide and p-anisidine value? And is the rTG form superior to the ethyl ester form in delivering the API (EPA) to the host, regardless of whether taken with a meal or what the fat content of the meal is? Yes, on all counts. And that’s what really matters. The API, and getting it into the blood stream.

Regards,
-MRC