An almost certain-to-pass bill with a new and noxious provision may be voted upon this weekend, and we need your help to stop it!
The Senate compounding bill we have been telling you about has now been scrapped because of the outcry from consumers like you. They started over from scratch and made many improvements. But they also added a new and really bad provision.
This section of the bill would ban the delivery of compounded nutriets delivered by IV (directly into your veins by a doctor) unless they are either on a pre-approved (USP Monograph) list or are components of FDA-approved drugs!
Think of that: a doctor may not be able to give you a vitamin or mineral you need unless it is not already in some completely unrelated drug! A doctor could use vitamin C because that has been included in some FDA-approved drugs as an additional ingredient. But he or she could not order some other vitamin or mineral which does not happen to be an ingredient of an FDA approved drug. How can this possibly make sense?
This provision resurrects section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C). Section 503A has been deemed invalid by federal courts: it’s currently the law only in the fifth circuit, which is comprised of three states—Texas, Louisiana, and Mississippi. This new bill would supersede the court decisions and make it the law throughout the country.
Besides making compounding nutrient IVs illegal unless they are pre-approved or contain elements already in FDA-approved drugs, section 503A also says that each state has to enter into a Memorandum of Understanding with the FDA. This Memorandum of Understanding would likely be used to severely limit interstate sales of compounded medications.
In other words, you might not be able to get the compounded medications you need from your pharmacy of choice. If a state doesn’t sign the Memorandum of Understanding, a mere 5% of the total prescription orders for any pharmacy in that state may go into interstate commerce. FDA has total discretion in the matter.
In many cases, what you or your doctor wants won’t be available inside the state. The only way to get it is to go to a leading compounding pharmacy out of state. But you may not be able to do that anymore if this provision becomes law. Or you may have to settle for an in state compounding pharmacy that is not the one you know and trust. Either way, vital compounded medications such as bioidentical estriol or customized thyroid medications could be at risk.
As we mentioned, some items in the new Senate compounding bill address earlier concerns we had and thus represent an improved version:
- The new bill doesn’t tell compounders that physician office use of their drugs can only represent 10% of sales (how would they be able to know?) or require physician reporting within a few days. But—and this is a serious “but”—all office use compounding (that is, compounding in the physician’s office in advance of a patient prescription) would have to be done by an “outsourcing facility,” which would be limited to a pre-approved list of medications.
- The bill doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned—though the bill still authorizes FDA to develop a demonstrably difficult to compound list.
- On the downside, as in the old Senate compounding bill, compounded “copies” of FDA-approved and marketed drugs would still be illegal, even if customized dosages are needed for the patient. This would enable drug companies to raise prices on already sky-high-priced drugs.
P.S.: Monsanto Rider Appears Dead
All thanks to your efforts!
Please don’t think your calls and letters don’t matter—they do. The Monsanto Protection Act has apparently been stripped from the Senate’s version of the government funding bill! You spoke out and our allies in the Senate listened.
This provision, which strips federal courts of the authority to halt the sale and planting of potentially hazardous genetically engineered crops and which was inserted at the last minute in a funding bill back in March by allies of Monsanto and other GMO companies, now appears to be history. Sen. Barbra Mikulski, chair of the Senate Appropriations Committee, said, “My promises made are promises kept. . . . There’s no reason for [the Monsanto Protection Act] to be included in a short-term CR [Continuing Resolution].”
Thanks to you and the many groups fighting alongside us, the Monsanto machine did not get their way! But now we need your help once again to protect consumer access to important individualized compounded medications. Please don’t let them make some really important compounded IV medications illegal! Someone you love may desperately need them. Please read more about this terrible provision on our website, and take action immediately!
