Compounding Pharmacy Bill: Third Draft, Still Some Major Problems—and No Time to Lose! May 21, 2013

The revised draft bill was released to us today, with no substantive changes. The Senate votes in a couple of days—Action Alert!

Senate bill S. 959 is a large and complex piece of legislation on compounded drugs. We received the third draft moments ago. As we reported last week, the second draft was much improved over the first, thanks to your messages, but unfortunately the third draft does not fix the remaining problems. In particular, the bill allows the FDA to disallow entire categories of compounding drugs in “complex dosage forms” such as extended release products or transdermal patches. Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form.

Another concern: estriol (the bioidentical hormone) has a USP-NF monograph, so legally it can be compounded. But this bill would allow FDA to identify bulk ingredients that are “drugs not suitable for compounding” based on unnecessarily vague “public health concerns,” even though they have a monograph as estriol does! In the past, the FDA has attempted to ban bulk bioidentical estriol at the request of a pharmaceutical company. The current language of the bill could allow FDA to regulate away your access to that medication, currently used by millions of women who refuse to take the synthetic hormone drugs that have been proven to be so dangerous. We must not let the FDA take away bioidentical estriol.

We believe this bill simply provides the FDA, which has been historically biased against supplements and integrative medicine, too much discretion to ban compounded drugs, including complete thyroid medications as well as estriol and other hormones. We still hope to get this message across and are working with the Senate HELP Committee to amend the language, to ensure that only compounded drugs for which there is very good reason to believe they can cause harm to consumers should be banned, but we urgently need your help once again—and this alert goes out to the entire Senate, not just the HELP Committee.

The bill is scheduled to be marked up in committee tomorrow (Wednesday, May 22). Very soon after that, it is expected to the floor for a vote of the full Senate. Your message to your senators is critical. Please take action immediately!

quoted from here