FDA 'COMPOUNDING' & 'WYETH 'PREMARIN

[Guest guest]

Dee,

Thanks so much for providing all those links! It took awhile for me to find that

would work, but i did and was able to submit my comments. I was all prepared

to scribble something tomorrow and fax it if necessary.

The statement from Madeus compounding pharmacy about Premarin had some

excellent and appalling information in it that i hadn't seen before. (And i thought i had seen it all!)

Hollis

[Guest guest]

HI Hollis. Yes I've sent a couple of letters to the FDA about that.... (one is below but not proud of it (at all) I did it so fast, and just off the cuff. *groan* And I've also written my representative.

Anyway here are various links that should help, I sort of collected these as I went along so it's sort of helter skelter.

Dee~

Link to a press release from the International Academy of Compounding Pharmacists (IACP) . (same text I put below) *http://tinyurl.com/b5bez*

Direct link to the electronic form to provide commentary to the FDA against the intent of this docket. (this is the one where it will go to the FDA) *http://tinyurl.com/bll9t

To read more from a compounding pharmacy (Medaus) about the FDA & Wyeth and bioidenticals click this link

http://www.medaus.com/?p=208,7814

http://tinyurl.com/b5bez (text is here)

IACP Finds Numerous Flaws With Wyeth Citizen Petition Regarding Bioidentical Hormone Replacement Therapy

SUGAR LAND, Texas, Oct. 27 /PRNewswire/ -- Today the International Academy

of Compounding Pharmacists (IACP) sharply criticized pharmaceutical

manufacturer Wyeth for manipulating the law and facts in an attempt to

restrict patients' access to customized bioidentical hormone replacement

therapy (BHRT). On October 6, 2005, Wyeth petitioned the Food and Drug

Administration (FDA) to impose far-reaching restrictions on physicians'

ability to prescribe and pharmacists' ability to prepare and dispense

bioidentical hormones.

"Wyeth's aims are clear: to restrict the ability of physicians to

prescribe and patients to use customized BHRT following studies that have

raised serious health concerns with the company's own products," said L.D.

King, executive director of IACP. "When and discovered that

Tylenol had been contaminated, it didn't file a petition to limit access to

ibuprofen; it acted responsibly and fixed the problem. Wyeth would be wise to

follow this responsible course."

IACP said that one example of Wyeth's contorted logic in the petition is

that the company is trying to have it both ways: arguing that bioidentical

hormones are illegal because they are copies of off-the-shelf pharmaceuticals

on the one hand, and claiming that compounding pharmacists are fabricating

new, untested drugs on the other. The truth is that compounding pharmacists

are preparing bioidentical hormone replacement therapies, which doctors design

and prescribe to meet their patients' individual needs.

The organization also said the Wyeth petition is trying to mislead FDA by

suggesting that compounding pharmacists are "simply trying to dupe an

unsuspecting patient population." Wyeth knows full well that physicians must

prescribe BHRT for each patient before a pharmacist can provide her with this

medicine, just as they would order Wyeth's own medications. Yet Wyeth completely ignores the role physicians play, never mentioning them in the

petition. To suggest that pharmacists who prepare customized medicines based

on doctors' orders are duping patients is an insult to all physicians,

patients and pharmacists, the organization said.

IACP said it will formally oppose the Citizen Petition in its own response

to FDA in the weeks ahead. The organization cited a number of other

substantive flaws with the Wyeth petition.

* Wyeth wrongly presumes that FDA's authority extends completely across

every facet of the practice of compounding. This is incorrect;

pharmacy compounding is a wholly distinct practice and is not subject

to the same requirements as manufacturing. Since the Food, Drug, and

Cosmetic Act of 1938 passed, compounding has been regulated by state

boards of pharmacy, not the FDA. In fact, because compounded

bioidentical hormone replacement therapies are prepared to meet

patients' individual needs, they are inherently incompatible with the

FDA's years-long new drug approval process required of manufactured

pharmaceuticals.

* Wyeth mischaracterizes the First Amendment protections to commercial

speech and misconstrues the U.S. Supreme Court's Western States

ruling. Wyeth is trying to undermine the Supreme Court's decision,

which found that "prohibitions on soliciting prescriptions for, and

advertising, compounded drugs amount to unconstitutional restrictions

on commercial speech." While the court also affirmed that

"misleading" advertisements are not protected by free speech -- a

ruling IACP supports and its policy reflects -- Wyeth's condemnation

of virtually any communication regarding BHRT is excessively broad,

contrary to Western States, and would violate the First Amendment if

enforced by the FDA.

* Wyeth relies on bad science to support many of its claims. The only

study Wyeth uses to support its contention that compounding is unsafe

has been criticized in the U.S. Senate and is not supported even by

the FDA. When pressed on the scientific value of the data during an

October 2003 Senate hearing on pharmacy compounding, FDA's then acting

director of the Center for Drug Evaluation and Research, Dr.

Galson, explained, "I wasn't trying to present these as scientific

data. Most notably, I wasn't trying to use them to urge or call for a

new Federal regulation."

* In its filing, Wyeth itself blurs the line between synthetic and

bioidentical hormones. Most notably, Wyeth suggests that the National

Institutes of Health Women's Health Initiative (WHI) studied

bioidentical hormone therapies. It did not. Rather, WHI studied

Wyeth's products exclusively and the study was cut short in 2002 after

the data demonstrated that Premarin® (synthetic estrogen) increased

the risk of stroke and the components of Prempro®, Premarin plus

progestin (synthetic progesterone), increased the risk of strokes,

breast cancer, heart attacks and blood clots. According to Wyeth's

latest annual report, sales of Premarin-related products suffered

since the study ended, having declined about 32 percent to $880

million in 2004 from $1.3 billion in 2003. The physical components of

BHRT are different from the components of Wyeth's synthetic hormones

that were studied by WHI.

* Furthermore, Wyeth has had its own problems with FDA rules governing

advertising. In a letter from FDA dated January 11, 1999, the FDA

said that promotional materials for Premarin were "false or

misleading, and promote Premarin for unapproved uses." One year

earlier, the company had received a letter saying that a television

advertisement for Premarin was "false or misleading."

As the Cincinnati Enquirer reported this month, "For some women, hormone

replacement therapy is the only thing that eases symptoms. More women are

turning to bioidentical hormones -- custom-compounded mixes of estrogens and

progesterone that are identical to hormones produced by the body."

Continued Mr. King, "Pharmacy compounding is performed by responsible,

trained professionals who have strong relationships with their patients and

their patients' physicians. The successful practice of pharmacy compounding

is predicated on full, open and honest communication between these three

groups of people. However, by attacking these communications and the ability

to treat patients, Wyeth's petition would do far more harm than good. As a

result, IACP will request that the FDA deny Wyeth's petition."

About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-

profit association founded in 1991 to protect and promote the art and skill of

the compounding pharmacy profession. We represent more than 1,800

pharmacists, physicians, technicians and patients who are committed to the

safe practice of pharmacy compounding. We are committed to ensuring the

rights of physicians to prescribe, of pharmacists to prepare and of patients

to take customized medications that meet their unique, individual needs.

SOURCE International Academy of Compounding Pharmacists

Let YOUR voice be heard here to the FDA

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTQUESTION.CFM?EC_DOCUMENT_ID=794 & SUBTYP=Not & ZIP=44511 & COUNTRY=USA & PREFIX=Ms. & FIRST_NAME=Delores & LAST_NAME=Troll & ORGANIZATION= & CATEGORY=Individual%20Consumer & COMMENTER_ID=0 & EC_ISSUE_ID=1143 & AGENCY=FDA

(the above link will take you directly to the FDA as well)

Here's my letter..... wish I'd taken a little more time to think about it tho. *sigh* I'd have added a lot more. grrrrrrrrrrrrrr

Docket Management Comment Form

Docket: 2005P-0411 - Seeking FDA Actions to counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs that Endanger Public Health Temporary Comment Number: 53357

Submitter:

Date:

Organization:

Category:

Issue Areas/Comments

General

To whom it may concern:

I cannot believe the audacity of Wyeth drug company to even suggest that compounding pharmacies are anything but on the up and up and I feel it's purely a retaliatory reaction to the loss of money with their own product Premarin after it's part in the WHI study and the results. (and others if I may add)

No wonder we women have gone to the natural bio-identicals hormones. And.... it's with prescriptions in hand as given to us in the first place by our own physicians who DO know our health status. If the FDA listens to this request or submits and kow tows to it, they too are in cahoots as far as I'm concerned and it's purely a political issue with money as the bottom line and it's NOT in the best interest of the health of women, (or men for that matter) AT ALL.....which IS what the FDA is suppposed to be about!!!

I'm just really upset & disgusted with this whole thing. I've used a compounding pharmacy for years as well as researched hormones specifically for many years and I DO know the difference and the benefits as each prescription can be compounded to be specific for that one person by their own physician.

I have been tremendously pleased with the one I use and have never had a problem with service or quality or dependability. Please please consider the ramifications of such a thing and do what is right for the public as a whole not for those with deep pockets.

Sincerely,

Dee T.

Attachments

No Attachments

other dockets you can comment on as well.

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?CID=79966 & AGENCY=FDA