Senate bill S.959, now being called the "FDA Power Grab Bill," would widen the powers of the FDA and allow it to disallow entire categories of compounding drugs in "complex dosage forms," including time-released and transdermal patches. It would give the FDA authority to ban bioidentical hormones and restrict access to compounded medications, even when your doctor has determined they are the best treatment for you.
And it's not just bioidentical hormones that are at risk if this bill is passed. Other medications that could be limited or banned include compounded medications for pain, autism, and for pets. Patients could be forced into changing to generic prescriptions, with their accompanying side effects.
Senate bill S.959 also would give the FDA power to determine which bulk ingredients are not suitable for compounding. One hormone at risk is bioidentical estriol.
In 2008, the FDA tried to ban bioidentical estriol in response to a petition filed by Wyeth Pharmaceuticals, which manufacturers synthetic hormones that compete with bioidenticals. The FDA instituted import bans on estriol and sent warning letters to suppliers and pharmacies in an effort to prevent women from obtaining bioidentical hormones with estriol. Fortunately, the FDA was unable to enforce these actions at the time. However, Senate bill S.959 gives them that authority. If S.959 is approved, it is almost assured that bioidentical hormones would be eliminated.
S.959, the FDA Power Grab Bill, is the largest expansion of FDA power in decades. If enacted, the proposed bill would destroy compounding pharmacies and cause irreparable damage to the health of millions of Americans who depend on compounded medications and bioidentical hormones.
It is critical that the S.959, the FDA Power Grab Bill, be defeated. We ask you to join us in speaking out against Senate bill S.959 by contacting your legislators and telling them that you do not support any policy or law that does not reflect the importance of personalized medicine. Email your Senators and Congressmen today, asking them to oppose S.959. Please make your voice heard!