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Draw Your Own Conclusion- Is FDA Doing Wyeth's Bidding?

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Timeline

Here are some events that have occurred in compounding medicine, bio-identical hormone, and synthetic hormones in the United States.  Help us make it better!  Send your comments to office@healthfreedom.net .

Date

Event

17th Century

John Winthrop, Jr., governor of Connecticut and son of the first governor of Massachusetts, is one of the first Americans to engage in compounding.  Click here.

1820

The United States Pharmacopoeia ("USP"), an official compendium of drug information recognized as authoritative in medical pharmacy includes instructions on compounding.  Click here.

1938

Following the infamous “elixir of sulfanilamide” incident where more than 100 patients died from taking a drug containing a poisonous solvent, Congress passes the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938.  Besides adding new quality standards for both food and drugs, the law, for the first time, requires drug manufacturers to provide evidence that their products were safe before they could be approved by the U.S. Food and Drug Administration (FDA) for marketing.  The intent seems to be to regulate drug manufacturers, not pharmacy compounders.  

1938 and after

Every state permits compounding. Pharmacists are licensed and trained to compound in every state. These state laws do not change after passage of the FD&C Act. Compounding remains a state-sanctioned, state-licensed activity. 

1943

Wyeth merges with Ayerst, McKenna and Harrison, Ltd. of Canada. With this merger comes Premarin, the world's first conjugated estrogen medicine, which becomes one of Wyeth's flagship products. Click here .

1962

Congress passes a new law, The Drug Amendments of 1962, which authorizes the FDA to certify a drug's efficacy, as well as its safety. Drugs approved before that time, like Premarin, were required to submit a supplemental application demonstrating efficacy to the FDA.  Click here.

1970

Congress passes a law regulating controlled substances. It gives an exemption for compounding pharmacists under certain circumstances. The U.S. Drug Enforcement Administration’s (DEA) implementing regulations also give compounding pharmacists an exemption.

1970

Premarin's composition is validated by the United States Pharmacopoeia (USP).

1972

Premarin tablets are certified by the FDA as effective for treating menopause.

1970s-1980s

Several smaller companies, including Duramed Pharmaceuticals, offer a generic of Premarin.

1984

Congress enacts the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417).  Also known as the “Hatch-Waxman” law, it establishes a statutory mechanism to facilitate more rapid approval of generic drugs. At the same time, it gives drug companies added years of patent protection as compensation for marketing time lost during FDA review.  Click here.

1986

Based on studies conducted by Wyeth, the FDA approves Premarin for treatment of osteoporosis.

August 2, 1989

Memo from David G. Adams, FDA Associate Chief Counsel, in response to questions from the Center for Drug Evaluation and Research, outlines what the FDA has to do and how they need to move forward to brand all compounded drugs and “new drugs.”  Among other things, the FDA acknowledges in this memo that its theory that compounded medicines are “new, unapproved drugs:”
“is a departure from the traditional approach we have taken;” (p. 1)
“will likely face a variety of practical problems, as well as two significant legal issues: (1) whether we have jurisdiction over this aspect of the practice of pharmacy and (2) whether we can regulate intrastate sales of unapproved new drugs;” (p. 1)
will require “the establishment of new legal precedents;” and (p. 2)
“may prompt an outcry from the general community of pharmacists and physicians;” (p. 4)
“leaves pharmacists in the objectional [sic] position of ‘living in sin.’” (p. 4)

1990

Wyeth-Ayerst tells the FDA that the generic products on the market releases estrogens more quickly into the blood stream than Premarin.  Relying on the Waxman-Hatch Act's requirement that a generic have the same rate (how fast the drug enters the blood) and extent (how much total drug enters the blood) of absorption as the listed drug product, Wyeth-Ayerst pounces on this discrepancy and begins a campaign to take the generics off the market. Click here.

1991

The Women's Health Initiative (WHI) is initiated by the National Institutes of Health (NIH).  The objective of this women's health research initiative is to conduct medical research into some of the major health problems of older women.  Click here.

1992

Congress passes the Prescription Drug User Fee Act (PDUFA), which authorized FDA to collect fees from drug companies in order to speed up the new drug application review.  Click here.

March 1992

Responding to a significant increase in pharmacy compounding, FDA issues a compliance policy guide (CPG), section 7132.16 (later renumbered as 460.200) to delineate FDA’s enforcement policy on pharmacy compounding. Click here.

1993

Premarin becomes the #1 prescribed drug in the US (and remains until 1999).  Click here

1993

Wyeth founds the Women's Health Research Institute, for research in women's health.

1997

The Food and Drug Administration Modernization Act of 1997 [503a (353A) of PL105-115] states that, among other things, items listed in the USP monograph (United States Pharmacopoeia or National Formulary monograph) are exempt from FDA new drug jurisdiction. Click here.

1997

Premarin becomes the company's first brand to reach $1 billion in sales.  Click here .

May 5, 1997

FDA rejects Duramed Pharmaceuticals application for a generic version of the drug Premarin.  Click here.

November 1998

Seven compounding pharmacies challenges the legality of the Food and Drug Modernization Act of 1997 - Section 503A which includes prohibitions on the solicitation of prescriptions for, and the advertising of, compounded drugs as an impermissible regulation of commercial speech. A federal district court ruled in the pharmacies’ favor and held that the solicitation and advertising restrictions violated the First Amendment. On appeal, the Ninth Circuit Court of Appeals affirmed the District Court’s holding that the solicitation and advertising provisions unconstitutionally restricted commercial speech.  The Court also declared section 503A to be invalid in its entirety, meaning that the unconstitutional speech provisions could not be severed from the rest of 503A.  Western States Medical Center v. Shalala, 238 F.3rd 1090 (9th Cir. 2001)).  FDA shares the Ninth Circuit’s view that section 503A is now void.  Click here.

1998

The FDA collects $132.7 million in user fees, per PDUFA.  The FDA does not collect drug user fees from compounding pharmacies because they are regulated by the states, not the federal government. Click here.

October 19, 2001

Wyeth requests to see the Women’s Health Initiative data. Researchers are worried that the data may be manipulated or will be used to undermine study's conclusions about the risks of hormone therapy. Initially, the National Institute of Health (NIH) is reluctant to share the data because its researchers did not feel all of the findings had been thoroughly evaluated. Additionally, the Premarin portion of the study was continuing and researchers did not feel it was appropriate to turn over the data to Wyeth when the entire study had not yet concluded.  Under the Freedom of Information Act (FOIA), an act that states a federal agency must disclose requested records, Wyeth demands to see the WHI findings from the NIH. While WHI researchers continue to analyze the finding, NIH officials agree it is in the best interest of their partnership with Wyeth to provide the data voluntarily. In turn, Wyeth withdraws the FOIA request and signs an agreement not to publish articles on the new data.  Click here .

2001

11 million women use a Premarin product.  Click here.

April 29, 2002

In Thompson v. Western States Medical Center, United States Supreme Court decides that The Food and Drug Administration Modernization Act of 1997 (FDAMA) exempts “compounded drugs” from the Food and Drug Administration’s (FDA) standard drug ap­proval requirements under the Federal Food, Drug, and Cosmetic Act (FDCA), so long as the providers of the compounded drugs abide by several restrictions, including that the prescription be “unsolicited,” 21 U. S. C. §353a(a), and that the providers “not advertise or promote the compounding of any particular drug, class of drug, or type of drug,” §353a(c).  Click here .

May 2002

The Women's Health Initiative links Premarin and Prempro®, synthetic hormone drugs manufactured by Wyeth to increased risk of stroke, breast cancer, heart attacks and circulatory disease.  Click here.

May 7, 2002

The FDA issues Compliance Policy Guide section 460.200 [“Pharmacy Compounding”] in CPG in final form, and requested and received numerous comments on it.  FDA states that it would review these comments and revise the CPG, if appropriate.  That process is underway, and FDA plans to issue a revised CPG, in draft, for public comment.  Click here.

July 2002

Premarin and Prempro sales fall drastically.  Click here .

July 22, 2002

Law firms across the country rush to capitalize on the just-released findings by filing complaints for class-action lawsuits against Wyeth.  Click here.

October 23-24, 2002

Nearly 1,000 doctors, researchers, and drug company officials gather at the National Institute of Health in Bethesda, Maryland, for the Scientific Workshop on Menopausal Hormone Therapy to consider how to advise a growing population of middle-aged women – now that the most popular brand of HRT has been show to cause cancer and heart disease.  Click here.

January 8, 2003

The FDA orders Premarin and Prempro to carry a warning label listing the drug's risks for heart disease, stroke, breast cancer, pulmonary embolisms and blood clots.  Click here.

October 23, 2003

The Senate Committee on Health, Education, Labor, and Pensions holds a Congressional Hearing: Hearing: Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients. Kevin Kinkade, Executive Director, Missouri Board of Pharmacy testifies, “…the art of compounding has been a traditional part of the practice of pharmacy for centuries. In fact, until after World War II when drug manufacturing became more prominent, compounding was one of the principal practices used to provide needed drugs to patients. While the need for compounding of products has changed since then, the importance of compounding certain products by prescription is still a very important and necessary part of the practice of pharmacy. Many physicians and patients across the United States depend on pharmacists.”  Click here.

2004

Sales of the drugs, Premarin and Prempro plummet from $1.3 billion in 2002, to $880 million in 2004.  Click here.

2004

The FDA receives $232 million in drug user fees, per PDUFA, which now funds more than half the agency's critical drug-review process.  The FDA does not collect drug user fees from compounding pharmacies because they are regulated by the states, not the federal government.  Click here .

2004

Ten pharmacies specializing in compounding brings suit in the United States District Court for the Western District of Texas, challenging FDA’s authority to regulate compounded drugs.  In August 2006, the court ruled, among other things, that compounded drugs are “implicitly exempt” from the FD&C Act’s new drug approval provisions.  Medical Center Pharmacy v. Gonzales, 451 F. Supp. 2d 854 (W.D. Tex. 2006).  The government has filed an appeal with the U.S. Court of Appeals for the Fifth Circuit.  Pending resolution of this appeal, the district court’s decision applies in the Western District of Texas.  Elsewhere, FDA continues to be guided by the 2002 CPG when considering enforcement actions regarding compounded drugs. 

October 6, 2005

Wyeth, the drug company, files a “Citizens’ Petition” demanding that the FDA ban bio-identical hormones which happen to compete with Wyeth’s synthetic hormones.  Click here .

August 30, 2006

The United States District Court for the Western District of Texas releases opinion in Medical Center Pharmacy v. Gonzales, holding that lawfully compounded drugs for humans and for non-food-producing animals fall outside the definition of “new drugs” and “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”). Specifically, the court finds that extemporaneous compounding of drugs is authorized under 21 U.S.C. § 353a (Section 503A of the FDCA) and such compounding is thereby exempted from the drug approval process and outside the scope of the definitions of “new drug” and “new animal drug” under sections 201(p)(1) and (v)(1) of the FDCA (21 U.S.C. § 321(p)(1) and (v)(1)). The court characterized this as a “narrow exemption.”  Click here.

January 29, 2007

A Philadelphia jury finds that Prempro was responsible for Mary Daniel's breast cancer and orders Wyeth to pay $1.5 million in compensatory damages. The jury concludes that Wyeth was negligent in failing to provide adequate warnings about the risk of breast cancer associated with Prempro. Click here.

March 29, 2007

Congress introduces H.R.1812 - To provide for coverage of hormone replacement therapy for treatment of menopausal symptoms, and for coverage of an alternative therapy for hormone replacement therapy for such symptoms, under the Medicare and Medicaid Programs, group health plans and individual health insurance coverage, and other Federal health insurance programs.  Click here .

March 2007

Sen. Kennedy (D-MA) drafts the so-called, Safe Drug Compounding Act.  Patients and the health freedom community flood Congress with messages of support for bio-identical hormones and compounding medicine.  One Senator pulls sponsorship and the bill is put on hold.  Click here.

March 2007

A pilot study shows that Estriol could be beneficial in treating multiple sclerosis.  Dr. Rhonda Voskuhl, director of UCLA's Multiple Sclerosis Program states, “The beauty of Estriol is that it can be given as a pill, not a shot, and also that it's not a new drug; it has decades of safety behind it." She also that Estriol has been in widespread use in Europe and Asia as hormone replacement therapy for women with menopausal symptoms. Click here.

April 12, 2007

American Association for Health Freedom holds summit to coordinate response to the FDA (and Wyeth) attacks on compounding medicine -- attended by International Academy of Compounding Pharmacists, women organizations, and other health freedom groups.

April 19, 2007

Senate Aging Committee holds Congressional Hearing: Bioidentical Hormones: Sound Science or Bad Medicine?  Steven K. Galson, M.D., M.P.H.- Director, Center for Drug Evaluation and Research testifies that the FDA considers compounded drugs as “new drugs” within the meaning of the Federal Food, Drug, and Cosmetic (FD&C) Act and that, like all new drugs, compounded drugs may not be introduced into interstate commerce without FDA approval.  The drugs that pharmacists compound are rarely FDA-approved and they lack an FDA finding of safety and efficacy.  Click here .

July 16, 2007

The FDA declines to approve Wyeth’s Pristiq (which would have been the first nonhormonal drug for menopause symptoms) without further testing. The agency wants more information on Pristiq's effects on the heart and liver because a very small number of women in patient tests had serious heart or liver complications.  FDA is requiring a new clinical trial of one year or longer, meaning Wyeth cannot get Pristiq approved as a menopause drug until mid-2009 or later.  Click here.

October 12, 2007

A jury levies a $134.5 million judgment against the pharmaceutical maker Wyeth in a lawsuit filed by three Nevada women who contended that the company's hormone-replacement drugs had caused their breast cancer.  It is the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits against the country in state and federal courts.  Click here.

2008

Drug user fees are expected to total $438 million and account for more than 42% of all the money the FDA receives for regulating drugs.  Click here .

January 7, 2008

FDA sends letters warning seven compounding pharmacies that they made false claims about bio-identical hormone replacement therapy, or BHRT.  Click here.

January 9, 2008

FDA responds to Wyeth’s Citizen Petition and grants portions of their request. Click here .

January 9, 2008

The FDA bans Estriol – which is used in 80% of bio-identical hormones.  They state that Estriol is not approved and unless they have a valid investigational new drug application, pharmacy operators may not compound drugs containing Estriol.  Click here.

January 9, 2008

In a press conference, the FDA admits that they know of no serious adverse events reported in conjuncture with Estriol. (Editors note: doctors and hospitals are required to report all adverse events). Click here.

March 4, 2008

In a letter to the U.S. Small Business Administration Ombudsman, the FDA announces that physicians wishing to treat their patients with drugs containing estriol may submit an investigational new drug application.   Click here