FDA -- Unapproved yet, but remain on the market until replaced by an approved version

[WillPower]

The following excerpt is from AP:

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NEW YORK – A liquid morphine painkiller given by family caregivers to dying patients can remain on the market, federal regulators have decided after hearing protests over their decision to remove it. The Food and Drug Administration had announced last week that it was ordering manufacturers to stop making 14 medications including the liquid morphine. All were developed so long ago they had never received FDA approval.

But on Thursday, the FDA's Dr. Douglas Throckmorton told The Associated Press the morphine liquid will remain on the market until it's replaced by an approved version or some equivalent therapy.

The reversal was welcomed by experts in hospice care and pain relief. One doctors group had told the FDA that last week's order would "cause extreme suffering for many patients who are nearing the end of life."
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Unapproved yet, but remain on the market until replaced by an approved version--this is probably the best case scenario we can aim for.

An unconditional and unrestricted exemption of e-cigs from the Food, Drug, and Cosmetics Act is extremely unlikely. Think from the lawmakers and FDA's point of view. If they provide an unrestricted exemption, can you imagine the political backlash if e-cig users start dropping like flies because of heavy metal or nicotine poisoning? Or e-cigs catch on like wildfire among teenagers and little kids?

Keep in mind that we are not offering them any self-regulation of e-cig industry. In addition, Morphine is at least controlled by Controlled Substance Act. Nicotine is not.

The second best option (among realistically probable options)? Case-by-case enforcement of FDCA for e-cigs, considering their intended (promoted) usage case-by-case. Which is exactly what FDA is doing now.
FDA is a cash (budget) strapped government agencies. If they go case-by-case examining the intended usage, as they claimed they were going to do, they won't be able remove e-cigs completely. Nor e-cigs would be a high-priority for them, until e-cigs show significant risk to public health.

In this case, FDA and politicians get their CYA cover, "e-cigs were illegal and we have been taking them off the market", just in case. Consumers don't get deprived of e-cigs. A convenient compromise of sort.

My 1 ml of PG (2 cents)

p.s. Sorry for the cross-posting to Campaigning forum.

[Jim Davis]

That's the government for ya. Try to ban a drug that eases suffering for a dying person. They just want to control it. Same as the e-cig. For every e-cig smoker that quits analogs, they loose revenue on tobacco taxes. Once they find a way to get their share, at our expense, they'll leave us alone. They don't give a flying ...... about us, it's all about the money.

[OutWest]

In this case I would suspect that it's big pharma that pushed for the FDA to ban it, because it's generic; and that they have a new, patented pain killer coming out soon. Like you said, though, it's all about the $

[jr.gotti]

That's the government for ya. Try to ban a drug that eases suffering for a dying person. They just want to control it. Same as the e-cig. For every e-cig smoker that quits analogs, they loose revenue on tobacco taxes. Once they find a way to get their share, at our expense, they'll leave us alone. They don't give a flying ...... about us, it's all about the money.

Sorry to be cliche, but quoted for truth.

It infuriates to hear the "doctors" on the news talking about possible nicotine poisoning and other "unknown dangers." When are we going to ban cars because of "possible car accidents?"

They don't care about us at all...and it's pathetic when they act like they do all in the name of making a few bucks. How long have e-cigs been around? It's only when a large amount of people stop dropping pennies in the goverments pockets by buying cigarettes, nicotrol, chantex, etc that they stop and say "Wow...we're going to lose money on this."

If they were concerned about our health where were they when these things first came out?

The hell with them all.

[TropicalBob]

Unapproved yet, but remain on the market until replaced by an approved version--this is probably the best case scenario we can aim for.

You are quite right. The FDA bashers here miss the point. My goodness, folks, this is an example of doing the right thing. The FDA showed a heart. It has been reviewing unapproved drugs and medical devices and issued a ban on this very high-dose morphine product as part of that review, since it was never approved. Then it heard from people who said the drug alone helped the dying. And the FDA reversed itself -- to the benefit of the dying and those who care for them.

E-smoking isn't that noble, but the recanting of a ban is a signal that we might have a dim light at the end of our own ban tunnel. We have a petition, we have politicians on our side, we have sent letters asking for this very thing.

Leave e-devices alone for a specified period of time and let manufacturers proceed with the testing and approval process. The alternative for many e-smokers is a return to tobacco cigarettes. To me, that's another form of dying. So if the FDA can show a heart for the dying, let them reverse the e-cig ban.

[strayling]

Excuse me for being less than kindly disposed to someone who steals something and later on gives it back.

[TropicalBob]

You referring the FDA "stealing" the drug? That reference confused me. The FDA has a mandated job to do, and it did its job in the unapproved morphine case. But when faced with the reality of the situation, real people badly needing that unapproved drug, it opted to allow distribution.

It didn't "steal". It banned on legal grounds. And as Willpower pointed that, the recent action is pretty darn noble.

[Fox3]

The only thing we are to them is Cash Cows(TM).

Be on crack or worse and you get all sorts of "help" (at taxpayer expense) to quit - rarely works from what I hear. Just keep YA bureaucracy in power and money.

This fecal matter (thanks) has got to stop. "Elections Have Consequences"...

Sick and tired of the power over .......s using flawed and cherry picked research to justify their desire for a power hard on.

Yes, I am disgusted, WAY beyond disgusted actually...

[strayling]

As usual, you're using a strictly legal definition and I'm using the common sense version. The FDA banned in haste and later admitted they were wrong. Hardly noble, especially when you see the nasty little rider they put on where they're going to ban it again as soon as they can find an alternative.

The FDA should be paying more attention to the 'F' in their title:

U.S. Food Safety No Longer Improving

An Agriculture Department campaign begun in 2006 to reduce salmonella contamination of meat and poultry has been successful, the report noted. But Dr. Robert Tauxe, deputy director of the C.D.C.’s division of foodborne diseases, suggested that whatever progress the department had made in improving overall food safety might have been lost by the F.D.A.

...

Roughly 76 million people in the United States suffer foodborne illnesses each year, 300,000 are hospitalized, and 5,000 die, according to C.D.C. estimates. Children younger than 4 are sickened by food more than those in any other age group, but adults over age 50 suffer more hospitalizations and death as a result of food-related infections.

[wyzardd]

As someone that's fought for 20 years to defend the 2nd Amendment, unless we vapers get loud and organized, I'm afraid we're sunk.