Editorial: D�j� vu all over again!

The following is from the FDA website:

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that their claims about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. The FDA is concerned that unfounded claims like these mislead women and healthcare professionals. The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

The FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, the FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research. "In addition to today's regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs' risks and whether they're getting effective treatment."

The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. The FDA regards this use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis. The pharmacy operations also make unsupported claims that their drugs are better than FDA-approved menopausal hormone therapy drugs and can be used to prevent and treat serious diseases such as Alzheimer's disease, stroke, and various forms of cancer. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by the FDA and the safety and effectiveness of estriol is unknown.

The FDA's action today does not target pharmacists who practice traditional pharmacy compounding and who do not make false or misleading claims about compounded products. Traditional pharmacy compounding typically involves preparation of a drug for an individual patient by a pharmacist in response to a valid prescription from a licensed practitioner. This compounding follows a practitioner's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. The FDA's current view on human drug compounding is addressed in its compounding Compliance Policy Guide, available at www.fda.gov/cder/pharmcomp/default.htm.

The FDA also responded today to a citizen petition from Wyeth (Madison, New Jersey) asking the FDA to take regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including healthcare providers and consumer groups, have also raised concerns about "BHRT" drugs.

All patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their healthcare provider to determine if compounded drugs are the best option for their specific medical needs. If patients or practitioners encounter problems with compounded hormone therapy drugs, they are encouraged to file a MedWatch report with the FDA at www.fda.gov/medwatch or by phone at 1-800-FDA-1088.

For more information, see a consumer article called Bio-Identicals: Sorting Myths from Facts www.fda.gov/consumer/updates/bioidenticals010908.html.

Editors' Note: Estriol is a component of the human body, has been commercially available in the past and has a USP monograph. This subject needs to be followed and special attention paid to ensure that the true facts are posted and to help ensure the rights of physicians to prescribe and patients to receive compounded HRT. As a reminder from last year, Human Hormone Replacement Therapy (Patterned after Human Insulin) may be an alternative.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Genentech, in collaboration with the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS), is pleased to provide an update on our joint efforts to address physician questions about access to Avastin (bevacizumab) after Genentech's January 1, 2008 change to the distribution of the product.

We are pleased with our collaboration and progress to date. Working together, we have determined that physicians can prescribe Avastin and purchase it directly from authorized wholesale distributors and wholesalers can ship to the destination of the physician's choice, including to hospital pharmacies, compounding pharmacies or directly to the physician's office. This process is one that the AAO and ASRS believe addresses the needs of their members. It is a significant step forward, reflecting the collaborative approach of Genentech and AAO and ASRS leadership.

An article titled Court OKs Compounding Pharmacy to Sell Controlled Substances to Vets, December 17, 2007, Article #11001, published on theHorse.com web site, discusses the U.S. Court of Appeals for the District of Columbia Circuit's December 11, 2007 decision that a veterinary compounding pharmacy has the right to dispense compounded formulations of controlled substances to veterinarians. This decision overturns an earlier action by the Drug Enforcement Administration (DEA).

This decision vindicated Wedgewood Pharmacy in their challenge of the DEA's decision to revoke their registration to dispense controlled substances (in 2006) because the DEA objected to the pharmacy's practice of delivering compounded formulations of controlled substances to veterinarians and physicians instead of directly to their patients. The DEA considered the pharmacy's practices as "manufacturing" and "distributing" of controlled substances by definition of the Controlled Substances Act. The DEA also claimed that under Wedgewood's DEA-registration as a "practitioner," it was authorized only to compound and dispense controlled substances; Wedgewood's argument was that "dispensing" included constructive delivery to an animal patient through a licensed veterinarian.

Circuit Judge Karen LeCraft Henderson, who wrote the unanimous ruling, stated, "�we cannot help but conclude that the DA's [DEA's Deputy Administrator] decision 'entirely failed to consider an important aspect of the problem,'�whether animal medicine operates differently from human medicine."

George J. Mamlberg, RPh, FACA, FACVP, the pharmacist president and CEO of Wedgewood Pharmacy, made some statements that are well worth quoting:

"The Court made clear its concern that the practice of veterinary medicine differs from the practice of human medicine. We believe that the current standard of practice in our profession, which is to dispense controlled substances to veterinarians rather than to horse owners or stable personnel, is consistent with the law's intention to prevent the improper use of controlled substances. We look forward to having our registration restored by the DEA, though the timing of that will depend upon the agency's response to this ruling."

Statements also made by Mamlberg were:

"This ruling tells us that we were correct in making arguments that the DEA rejected or ignored. We welcome the opportunity that this ruling now creates to arrive at a clear, sound understanding that works for all concerned. We want nothing more than to work cooperatively with DEA to resolve any issues it may still have with the current state of compounding pharmacy practice in the veterinary profession."

Unapproved Education
Patients need to know there are many unapproved drugs on the market and should not be shocked when announcements are made in the press. Obtain a list of these and make them available to your patients so they will know the facts.