listen up Stylistas!

[ensho]

http://www.feministpeacenetwork.org/2008/12/29/beyond-mascara-fda-considers-approving-drug-that-may-blind-you-for-eyelash-enhancement/


Beyond Mascara–FDA Considers Approving Drug (That May Blind You) For Eyelash Enhancement


As we come to the final stretch of 2008, plagued as we are with the usual collection of horrors–Gaza burning, Tennessee buried in toxic ash, women and children being raped and killed in the Congo, and on and on, I’m sure y’all were just as relieved as I was to know that the FDA is considering approval of a glaucoma drug for eyelash enhancement, an idiocy I would have previously thought would be confined to the cable shopping networks.

“Federal regulators on Wednesday said a glaucoma drug from Allergan appears to make eyelashes longer and fuller, and experts soon will assess the safety of that new use.”

No word on any plans to regulate the thousands of cosmetics already on the market that contain toxic ingredients for safety but we sure the hell hope they read the drug insert on this one regarding possible side effects:

“Blindness; blurred or decreased vision; change in color vision; color changes in skin around eyes; difficulty seeing at night; eye color changes; fever or chills; lack or loss of strength; redness, burning, dry or itching eyes; redness, pain, swelling of eye, eyelid, or inner lining of eyelid.”

Yes indeed, you read that correctly, as long as you don’t mind losing your sight, you too can have lucious lashes in yet another fine example of the pharmaceutical companies robbing us, literally, blind.
------------------------------

[FSogol]

1. Be sure to tell all the blind women that their lashes look fabulous

Sheeeesssh, what next?

Can we have some Government agencies that protect the public in lieu of protecting business interests? Please?

[enlightenment]

2. There have been at least two (maybe three)

products that use the drug for this use on the market for the last couple of years.

There are many more that use other methods to achieve the same effect (and are just as irritating).

Oddly, there haven't been any reports of people going blind.

The real story here is what the FDA did recently. They forced a company (Jan Marini) that was selling their version of this product like hotcakes to stop selling it because it was an 'unapproved' use of the drug and the risks were too great.

This was a smaller cosmetics company.

Now, Allergen, a LARGE company, is marketing essentially the same thing - WITH FDA approval.

Is the danger the drug and the risk to a user's eyes - or is it that the FDA didn't get their palms sufficiently greased by the other company first?

[ensho]

3. how very interesting - thanks for the info

nt

[anigbrowl]

4. Your summary leaves out the fact that Jan Marini was using Allergan's drug

Allergan developed the anti-glaucoma drug in the first place. Jan Marini was using without having sought FDA approval, and additionally Allergan alleged that JM had violated their patent in doing so. Manufacturers have to pay to have their products evaluated by the FDA, and it seems Jan Marini didn't bother to go through this step.
http://scienceblogs.com/terrasig/2008/01/jan_marini_finally_bats_a_lash.php

[enlightenment]

6. Well, yeah, there is that!

;)

I just get annoyed at the hyperbole. The FDA didn't cite patent infringement as a reason for seizing Marini's product; they implied that Marini was marketing a dangerous product. The patent issue was buried in the legalise.

That's annoying. If it was dangerous with Jan Marini's label on the box, why isn't it dangerous with Allergan's label on the box? Because they hold the patent?

Is it safe? Probably not terribly, though that could be said for a lot of things people use. Reading the package inserts and warning labels on most products would give most people pause (if they read them) because they include every single possible side-effect.

I probably wouldn't use it, even though I would love to have luscious lashes *snork* . . . but that's because I'm sure it would be irritating and red, itchy eyes aren't worth it for temporary lash growth - not because I'm afraid I'd go blind.

[anigbrowl]

7. There seems to be some confusion here

Allergan was accusing Jan Marini of patent infringement. That is a civil matter between the two companies.

The FDA cited Jan Marini because they didn't go through the approval process before marketing a product containing a drug used for purposes other than its primary medical one. Allergan sought and received the required approval. Sure, that's easier for them because they're a larger company (ie, they can more easily afford the fees), but it's not like a secret that you're supposed to get FDA approval before launching a product containing a drug. Seems like Jan Marini's lawyers didn't do a good job of advising their client.

It's bureaucratic, but that's what the FDA is there to do. If I mash up Tylenol and Aspirin and discover it makes my hair curly I can't just start selling it as 'curly hair from a pill'.

[enlightenment]

8. I'm not confused.

I understand the issue. My nitpick is over the public release that the FDA made when they went after Jan Marini. They very clearly stated that the issue was SAFETY. It wasn't, as you have pointed out in your responses. But do you see ANYTHING in that release that suggests the issue was one of patent infringement?

They presented their position as one of protecting the public from an 'adulterated cosmetic' when the actual issue was one of legalities, not safety.

The FDA has allowed Allergan to market a product which contains the SAME drug that they claim (in the release below) is a dangerous adulteration of a cosmetic. Why? Because, legally, Allergan owns the drug.

That's what really bothers me (along with all the shrieking and peaking about people going blind if they use the product . . . a related but slightly different issue).

FDA News

FOR IMMEDIATE RELEASE
November 16, 2007

Media Inquiries:
Brad A. Swezey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Approximately $2 Million of Potentially Harmful “Cosmetic” Eye Product Seized
Product contains drug ingredient, makes unapproved drug claims, could damage eye

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million.

Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.

FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).

For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug’s effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.

In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.

The U.S. Attorney’s Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.

The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product’s use.

[anigbrowl]

10. I'm afraid you are

It's the responsibility of the manufacturer to submit any such product for approval BEFORE they begin marketing it to the public. Allergan subsequently offered it for approval as a cosmetic product and testing apparently proved it safe. In other words, they did what they were supposed to - get approval for this use first, THEN put it on the market.

You don't just submit a drug and then it's approved for everything for ever. If you make a drug that cures sneezing and get it approved, then later you discover that it's also a cure for the hiccups, you have to have it approved separately before you can market it for that purpose. You can NOT just put 'also cures hiccups' on the box.

Forget about the patent issue for a minute. Let's assume the active ingredient was off-patent, as if nobody noticed the lash-extending 'benefit' for 10 years and the patent had since expired. Company A throws it into their product, calls it 'super secret ingredient' and just starts selling it. Company B files the required paperwork with the FDA and is granted approval to sell it. Which company is being more ethical here?

You seem to think Allergan was using the FDA to enforce its patent. Why would they bother, when there are effective legal remedies for patent infringement? If Jan Marini had got the FDA approval (as they were supposed to do) and started selling, then the California state attorneys would never have got involved, Allergan would have filed a lawsuit when they found out, if their lawsuit had merit then Jan Marini would have probably settled out of court. This happens all the time.

[enlightenment]

11. We are clearly on two different wavelengths.

Since you are convinced I'm confused and I'm convinced you're not 'listening' to what I'm saying (which doesn't really argue with your point), I'd say there's not a lot of point in trying to continue the conversation - such as it is.

It's simply not that important to me.

;)

[amitten]

5. No worse than the FDA-approved implants that deteriorate and

leak toxic crap into a woman's bloodstream.

[SoCalDem]

9. Boy, are the archaeologists of the future going to have a field day

Imagine what they will make of us:

field notes....(from a desolate desert just south of 5 large dry lakebeds)

...the female of the species appeared to have colorful fingernails made from some epoxy-resinous material, with elaborate designs painted on them, and had long eyelashes, composed of a yet-undetermined phamaceutical compound. The shoes on the feet, bear the inscription "Ferragamo"..The skeletal remains also include two gelatinaous sacs, resting on the ribcage.