Compounding pharmacies under attack

[Stephe]

http://www.mymedsmatter.com/

"Your access to bioidentical hormone replacement therapy (BHRT) is in serious jeopardy—again. Legislation is making its way through Congress that would give the Food and Drug Administration unprecedented control over compounding pharmacies that make BHRT.

Five years ago, the FDA tried to ban the most commonly compounded BHRT treatments. The agency failed because it did not have the authority to do so. This bill gives the FDA authority to do that and much more. It's that simple. Physicians and patients alike must tell Congress that you do not want the federal government involved in the prescriber/patient relationship and telling doctors how to run their practices."

The HRT I take has to be compounded and I'm not sure how many other TG's use compounded meds but for me this is bad news. I use trans-dermal estriol which isn't available in the US except from a compounding pharmacy.  If this law passes (there is heavy lobbying by the big drug companies), I will be forced to use meds bought over seas or from Canada. Not only is this questionable for me to do legally but it sends US dollars out of the country. I would still stay under doctors supervision of course but prefer to be able to order my meds in the US from my prescription and know what I am buying.

Please spend a few minutes and fill out their online forms to tell your representatives you think this is bad, even if it doesn't affect you personally. Thanks you in advance

[Flan]

Call me a skeptic but I don't see where the harm is. The substance at stake is one which many companies use in compounded substances that are not prescription controlled.

The FDA went full (stupid) over the substance as result of a petition.
http://www.citizen.org/documents/levinecertopp.pdf

S.959 text
http://www.help.senate.gov/imo/media/051513_PCQA_KER13192.pdf

What made s959 "needed"
http://www.cbsnews.com/8301-204_162-57586159/fda-seven-infections-tied-to-steroid-injections-from-tenn-compounding-pharmacy/
http://www.metrowestdailynews.com/features/x715756162/State-boards-back-more-FDA-oversight-of-compounding-pharmacies

[Ms. OBrien CVT]

There are some medications that are just as useful now, but because no drug compact can make money from them, they are no longer manufactured.  However compounding pharmacies can still make them.

They serve a purpose, but the big drug companies want to control our access to medications.

[Flan]

There are some medications that are just as useful now, but because no drug compact can make money from them, they are no longer manufactured.  However compounding pharmacies can still make them.

They serve a purpose, but the big drug companies want to control our access to medications.

They would be covered under Orphan Products
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

[Michelle-G]

Call me a skeptic but I don't see where the harm is. The substance at stake is one which many companies use in compounded substances that are not prescription controlled.

I was thinking the same thing.  And besides, isn't "trans-dermal estriol" simply estriol delivered by a skin patch?  How is this not available in the US?  I use patches for my HRT. 

And FDA oversight of the process of compounding this stuff won't mean that it will become unavailable, it just means the the FDA is watching over the people who make it.  That's why we have the FDA in the first place.

Looks like drug lobby propaganda.

[Stephe]

Call me a skeptic but I don't see where the harm is. The substance at stake is one which many companies use in compounded substances that are not prescription controlled.

The FDA went full (stupid) over the substance as result of a petition.
http://www.citizen.org/documents/levinecertopp.pdf

What does a lawsuit on the drug Phenergan made by Wyeth (now part of the drug giant Phizer) have to do with estriol, womens HRT or compounding pharmacies? Actually Wyeth was the major drug company that convinced the FDA to outlaw Estriol in 2008. And Estriol creme made from -real- meds like I use, not the fake -herbal hormone cremes-, requires a prescription. I'm not sure why you think this "substance at stake" isn't a prescribed medication?

http://www.naturalnews.com/022751_Wyeth_women_the_FDA.html

Here is the present FDA position on this drug.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183078.htm

"Estriol is not a component of any FDA approved drug and it has not been shown to be safe and effective for the uses for which it is being prescribed.", even though has been used for decades in other developed countries as an effective and safer type of HRT.

Part of this new legislation allows the FDA full authority to do whatever they want.

I was thinking the same thing.  And besides, isn't "trans-dermal estriol" simply estriol delivered by a skin patch?  How is this not available in the US?  I use patches for my HRT. 

You are very likely using estradiol, not estriol. Two very different meds.  And what I use is a transdermal creme which is much cheaper and easier to manage than patches. There is no form of estriol available AFAIK outside of a compounding pharmacy in the US. While this drug is regularly used in many other developed countries (A major drug company in England produces Estriol transdermal creme), the FDA doesn't see it as being useful to US citizens. No major US drug company has ever developed a use for it and in fact have spent considerable effort to ban it's use, in 2008 they almost succeeded.

http://www.anh-usa.org/access-to-estriol-2/

http://www.empowher.com/menopause/content/dr-christiane-northrup-congress-asks-fda-reverse-its-ban-estriol

This went to congress and they decided against the FDA ruling. This newest legislation would give the FDA power to do this again in a way that might not be possible to overturn. The drug companies are lobbying to block HRT from being produced by anyone but them.

"The harm" isn't for all of you on estradiol, it's for women like me on estriol. I can take Estriol without problems (and have had good results) but had horribly bad reactions to estradiol and couldn't continue taking it. I may soon not be able to obtain Estriol from anyone in the US, at least that is what my pharmacy informed me.

They would be covered under Orphan Products
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

Reading this, it doesn't appear it would apply to HRT unless you think there are less that 200,000 women who need it?

It is possible jumping through enough hoops my doctor can still prescribe it but A: is she willing to jump through all those hoops and can I find a doctor that is, B: are their going to be any compounding pharmacies left to make it for me. Obviously the FDA should have more oversight on these compounding companies as far as being sterile and not selling meds that cause meningitis etc. But this law goes FAR beyond that.

[DriftingCrow]

While I think compounding pharmacies do serve an important purpose, I think oversight is needed. Just recently (January or February) a compounding pharmacy in MA, which had no FDA oversight, had some of its medication contaminated with a fungus which killed the patients who took the drugs; like you mentioned at the end of your last post. Many bills put in place seem to be quite large, but then they can get pared down during the legislative process. Compounding pharmacies are supposed to make drugs from a prescription specialized for a particular patient, while many now make a bunch of drugs and ship them off without a prescription, making more like a manufacturer. That shouldn't be allowed, since they're morphing themselves into something they're not.

I do think the FDA itself needs a lot of changes, they often do not allow drugs or equipment to be used here in the USA that is deemed to be perfectly safe in European (or other "Western") countries due to corruption from US drug companies or just the incredible bureaucracy that requires applicants to jump through hoops.

It's just all a big giant mess, but overall I am not opposed to oversight on the compounding pharmacies that go beyond what was originally intended for their business. I am not sure what exactly is going on with the estriol bit since I don't take it or know much about it, though if it is safe, I wouldn't want the FDA to ban you ladies from taking it.


Though since this isn't exactly a news article on the original opening website, I am going to move this over to the HRT discussion board. 

[Jamie D]

"Every time a law is passed, a liberty is lost

Bureaucracies, like the FDA, thrive by aggrandizing their power-base.  If you don't believe me, look at the IRS.

[peky]

While I think compounding pharmacies do serve an important purpose, I think oversight is needed. Just recently (January or February) a compounding pharmacy in MA, which had no FDA oversight, had some of its medication contaminated with a fungus which killed the patients who took the drugs; like you mentioned at the end of your last post. Many bills put in place seem to be quite large, but then they can get pared down during the legislative process. Compounding pharmacies are supposed to make drugs from a prescription specialized for a particular patient, while many now make a bunch of drugs and ship them off without a prescription, making more like a manufacturer. That shouldn't be allowed, since they're morphing themselves into something they're not.

I do think the FDA itself needs a lot of changes, they often do not allow drugs or equipment to be used here in the USA that is deemed to be perfectly safe in European (or other "Western") countries due to corruption from US drug companies or just the incredible bureaucracy that requires applicants to jump through hoops.

It's just all a big giant mess, but overall I am not opposed to oversight on the compounding pharmacies that go beyond what was originally intended for their business. I am not sure what exactly is going on with the estriol bit since I don't take it or know much about it, though if it is safe, I wouldn't want the FDA to ban you ladies from taking it.


Though since this isn't exactly a news article on the original opening website, I am going to move this over to the HRT discussion board. 

^^^ +1

[Stephe]

I do think the FDA itself needs a lot of changes, they often do not allow drugs or equipment to be used here in the USA that is deemed to be perfectly safe in European (or other "Western") countries due to corruption from US drug companies or just the incredible bureaucracy that requires applicants to jump through hoops.

It's just all a big giant mess, but overall I am not opposed to oversight on the compounding pharmacies that go beyond what was originally intended for their business. I am not sure what exactly is going on with the estriol bit since I don't take it or know much about it, though if it is safe, I wouldn't want the FDA to ban you ladies from taking it.

I agree and have no problem with the FDA inspecting these facilities etc. My concern is the FDA did ban estriol in 2008 (while it's been in use for decades with no risk over what any HRT has, actually less!) and seems to be a lot of pressure from the drug lobby to get it off the market in the US as it competes with their HRT meds. This law should just be about oversight but all sorts of lobbyist paid for amendments are creeping into it.

And actually all I was asking is if people would write their representative to make sure they improve oversight but they don't also create a bill that would keep a compounding pharmacy from being able to make meds for people like me who need them.