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» LymeNet Flash » Questions and Discussion » Medical Questions » Urgent Action Alert! Revised Compounding Bill Vote Possible Tomorrow!

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Author Topic: Urgent Action Alert! Revised Compounding Bill Vote Possible Tomorrow!
Rumigirl
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web page
(ANH-USA.org webpage)

Probably the majority of us regularly use, or have used, compounded meds, as in IV abx from Infuserve (or other

pharmacies), glutathione, methyl-B12, LDN, bio-identical hormones, timed-release or otherwise compounded thyroid meds, pain formulas in gels, creams, patches, etc.

ALL of this is on the chopping block, if we don't move tonight or early tomorrow to contact our congress men and women. And

get everyone you know to do the same. This is really serious business. They are out for blood this time; it's NOT like all the other times prior.

Don't let BIG PHARMA sell us down the river! It's very simple to click and fill in your details. Add some personal detail, if you can, but just DO IT, please!

(You don't have to read the rest below, but it's pretty horrifying). It's from the UNH USA webpage.

"The reworked version of the bill is nearly four times longer—and is even more of a threat to your access to bioidentical hormones,

non-standard thyroid medications, and other compounded medications that millions of people rely on. Action Alert!

S.959, the compounding bill we’ve been telling you about, has been rewritten, and it’s now 189 pages long, up from its original

50 pages. It’s technically a substitute bill in the form of an amendment. This means that when the old bill comes to the

floor of the Senate, there will be a motion to substitute this new version. It will likely all happen very quickly—as early as

tomorrow. There is a big push to get it through the Senate before the August recess on Friday. That’s why your immediate action is urgently needed!

Several new provisions in the bill are especially troubling. For example, in this new draft, traditional pharmacies that do

compounding for doctors’ office use will need to limit their compounding to no more than ten percent of the products they

dispense in any thirty-day period! In addition, compounders must receive, within fourteen days, the name of each patient who received the compounded medication.

This is an administrative and logistical nightmare. First, the number of a doctor’s patients given compounded prescriptions

in the office will almost certainly ebb and flow; it’s unlikely they will neatly fit the ten percent cut-off within the rolling thirty-day

period. And to place arbitrary restrictions on how many of one’s patients can receive a particular medication interferes with the practice of medicine, to put it bluntly.

Furthermore, in the states that allow for the office use of compounded drugs, there are no such requirements. So this la

w will override the state laws currently in place. On top of that, having to match each patient, by name, to the compounder that

supplied the medication, and do so within fourteen days, would be logistically difficult if not impossible. The drafters of the bill

realize this. Their intent must be to eliminate this use of compounded medication indirectly by making it so difficult to comply.

In another provision, “compounding manufacturers”—a term that includes any compounder who ships by interstate commerce—

will only be able to compound those non-sterile drugs that are included on a list to be developed by the FDA. In other words,

these drugs must be pre-approved. You can be sure the FDA will create this list with an eye to ending competition with drugs that the agency has approved.

On top of these new difficulties, our previous concerns remain:

Bulk ingredients. The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public

health concerns,” which is an impossibly vague standard. FDA has attempted to ban bioidentical estriol because of such “health concerns” even though it has a USP monograph!

“Copies of drugs.” Compounded versions of FDA-approved drugs may be banned as “copies” of the drugs depending on how

strictly that term is interpreted. This could eliminate access to the much less expensive 17P in favor of the FDA-approved Makena drug. Remember that pharmaceutical companies view

compounding pharmacies as a threat to their market share. On the upside, the new version of the bill says that if the FDA-approved drug is in short supply, a pharmacy can compound the

drug—it only needs to provide one notice per year. Of course, “short supply” has to be defined by the FDA.
“Difficult to compound.” The bill allows the FDA to disallow

entire categories of drugs that are supposedly “difficult to compound,” and specifically names “complex dosage forms” as an example. This targets products such as extended-release

products and transdermal patches (for example, many consumers rely on time-release thyroid medication, which is not available in standard drug form).


Some small victories, however: in the previous version of the bill, there was no clear definition of what “difficult to compound” really meant. We had requested that bill include language that

exists in current law, and at least use a standard based on safety or effectiveness. In the new version of the bill, compounding must be “reasonably likely to lead to an adverse effect on the

safety or effectiveness of that drug or category of drugs, taking into account the risks and benefits to patients.” We also got them to remove the provision that compounders needed to

perform random controlled trials in order to meet a “safety and efficacy” standard, as well as the requirement that doctors must substantiate the need for a compounded prescription.

What this means is that your messages are working! Your legislators really do listen to you.

There is conflicting information on when the bill will come up for a vote. Last week our sources indicated it wouldn’t come up until after the August recess. Yesterday, however, we heard that it

might come up for a vote as early as tomorrow. The bill’s Senate supporters are pushing hard for a floor vote before the August recess, whereas Sen. Coburn said that more time was needed to

review the new language and have industry weigh in.

No time to lose, then! If this comes up for a vote this week, the Senate needs to hear from you TODAY! Your message is simple: ask your senators to oppose S.959."

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Catgirl
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Right on Rumi! I wish people knew how serious this actually is. I guess it's like anything else. They won't know until it's too late and actually affects them or someone they love.

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).

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beaches
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DONE!

And thx for posting this important information!

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Robin123
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Here's an action we can take - email this page immediately to any health providers we know who are prescribing compound meds - I just emailed it to a medical provider I know -
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beaches
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Excellent idea Robin! I will forward this on to whomever I can think of (tomorrow!)
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sammy
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Up for everyone to see
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Catgirl
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Great idea Robin!

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).

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Catgirl
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Done!

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).

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lymeinhell
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Up

--------------------
Julie
_ _ ___ _ _
lymeinhell

Blessed are those who expect nothing, for they shall not be disappointed.

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DaveNJ
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i spoke with my LLMD on Monday and she felt that this was a good bill as there is nothing place to ensure compounding pharmacies are maintainin ga clean and sanitary environment?

Dave

ps...don't shoot the messenger

--------------------
On my journey to wellness - One day at a time.

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Razzle
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Um, no, it gives Big Pharma and the FDA the power to destroy compounding pharmacies with red tape and restrictions.

--------------------
-Razzle
Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs.

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Lymetoo
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Big Pharma wants to control EVERYTHING.

--------------------
--Lymetutu--
Opinions, not medical advice!

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poppy
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Compounders are already under state regulation.

This bill is a backdoor attempt to close down compounders, pushed by big pharma and using a few rogue companies who hurt patients as the excuse. So, 99.9999% of compounders will be hurt and all of their customers so that supposedly our health will be protected because now FDA will have control. When the FDA does not have the manpower to do all the inspections and control for the areas they already have jurisdiction in.

And dummies will vote for it, in order to appear to be protecting public health.

The pharmaceutical industry has already been tampering with our ability to get insurance coverage of compounds. They have decided that compensation can only be based on one main ingredient, despite the fact that non-compounded drugs have other ingredients and are not handled this way. So, insurance companies can now pull tricks like using this pharma baloney to classify compounds as third tier and only pay for one ingredient. No compensation for having to prepare the compound. Leaving the patient holding the bag. The thing is that people are getting compounds often because there is no big pharma factory equivalent.

Health care in this country is broken.

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Catgirl
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Well said, Poppy, you nailed it! Unfortunately, too many people are asleep at the wheel when it comes to knowing about current bills, much less reading and comprehending them. It's also hard for lyme patients since lyme messes with our brains. That said, anyone with a brain would oppose this bill.

I don't know if they have voted yet, but it's still worth clicking on Rumie's link at the top of this page and forwarding it to your senators.

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).

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desertwind
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What sort of state regulation are compounding pharm.s under? What governing body regulates them? I get the issue most people have with this bill but at the same time there should be some safety regulations put into place.

Recall the meningitis outbreak? You really don't know what is in some of the stuff we take and I am not very comfortable with that. Not saying this bill is the answer but it does bring the need for safety regulation to awareness.

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Razzle
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It is my understanding that the pharmacy that caused the meningitis outbreak was under investigation by the FDA for violations, but that enforcement was lax.

The problem is enforcement, not lack of regulations.

--------------------
-Razzle
Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs.

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Catgirl
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Desertwind, that requires enforcement, not this bill. It's a completely separate issue than this bill. Proponents of FDA enforcement for compounding pharmacies just need to write a new bill that focuses on enforcing their law, not wiping out our rights to having anything compounded (way to go backwards). They are just mixing the two different issues together to confuse people, which seems to work. That's how crap like this gets passed.

Everyone should oppose this bill.

[ 08-06-2013, 10:39 AM: Message edited by: Catgirl ]

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).

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Rumigirl
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The company that caused the meningitis outbreak was NOTHING like usual compounding pharmacies. It was a huge mill, completely in violation of all existing laws. They weren't preparing rx's for individual patients.

Almost all usual compounding pharmacies are small operations that operate under far better conditions than the regular medications that are actually often made in India, Malaysia and other places where there is next to no oversight.

It is totally scary to me that so many of our meds, including our IV meds, are made in these places with no safety whatsoever. (This is a separate issue, of course).

Remember the heparin scare a few years ago, where the heparin was being made in dirt floor huts in China (for IV use)?! Separate issue, I know. That was regular meds, not compounded.

[ 10-16-2013, 05:17 PM: Message edited by: Rumigirl ]

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desertwind
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Seriously.....Even one death is one death too many. If it was your loved one who died from meningitis perhaps you would feel differently.

I don't disagree. Just saying that whether I am taking Doxy from the CVS down the street or ART from a compounding pharmacy or herbs from my local
health food store, I am much more comfortable when quality control measures are in place to ensure safety.

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Tammy N.
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Key Compounding Pharmacy posted an update on their site:

Even though proponents of Senate Bill 959 (legislation relating to compounding) pushed for considerations of the legislation this week, the bill has been delayed and will be voted on sometime after Labor Day. Congress is out of session until September 9.

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Beverly
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Thank God it's been delayed! I am on LDN

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God Bless You! Everything..is just my opinion.

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