Wyeth petitioned the FDA to impose far-reaching restrictions on physicians' ability to prescribe and pharmacists' ability to prepare and dispense bioidentical hormones.

Fact: Wyeth's petition is driven by a self-serving interest to limit access to an alternative to its synthetic hormones, sales of which are flagging in the wake of a study that suggested increased risk of serious adverse events.

The National Institutes of Health Women's Health Initiative (WHI) studied Wyeth's products exclusively and the study was cut short in 2002 after the data demonstrated that Wyeth's products 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.

Throughout the filing, Wyeth makes many misleading and false claims. For example:
Wyeth insults physicians by ignoring the role they play in prescribing BHRT, instead suggesting that compounding pharmacists are "simply trying to dupe an unsuspecting patient population."

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.

Wyeth also mischaracterizes the First Amendment protections to commercial speech and misconstrues the U.S. Supreme Court's Western States ruling, which states that "prohibitions on soliciting prescriptions for, and advertising, compounded drugs amount to unconstitutional restrictions on commercial speech."
Further, the vast majority of ostensibly independent organizations that filed comments with the FDA in support of Wyeth's petition have ties - financial and otherwise - to the company. To read the truth about comments filed in support of the Wyeth petition, click here.

This is not the first time that Wyeth has engaged in a self-serving campaign to influence FDA. Click here to learn about Wyeth's campaign to Stifle Generic Alternatives.