On Saturday the compounding bill passed the House by voice vote on motion to suspend the rules. The Senate could vote on it as early as today. URGENT Action Alert!
As we reported last week, the compounding pharmacy bill we had been warning you about was scrapped because of the outcry from consumers like you. The new bill, HR.3204, the so-called Drug Quality and Security Act, was passed by the House of Representatives in a voice vote.
This means of course that there is no record of anybody’s specific vote. The chances of changing it in the Senate now are very low, but they could take up the bill under unanimous consent and voice vote as soon as today or perhaps tomorrow, so please write your senators one more time—and phone them as well!—because miracles do sometimes happen.
Let’s keep in mind the reasons why this bill, despite numerous improvements, is still so bad:
- The new bill contains sections that would ban doctors from prescribing compounded nutrients delivered intravenously unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs. Imagine: your doctor cannot give you an IV containing natural vitamins and minerals unless these ingredients happen to be in some FDA approved drug! Moreover, such IVs are some of the best tools that integrative doctors have.
- The language about needing to have a USP monograph or being components of FDA-approved drugs came from an old section of the Food, Drug, and Cosmetics Act that had been deemed invalid by federal courts, so in 47 states, physicians have recently had the freedom to prescribe and dispense compounded nutrients of their choice by IV. If the new bill passes, this will become illegal in all 50 states, at least until another legal challenge can be mounted.
- The bill makes the falsification of a compounded prescription a federal criminal act. The trouble with this is that states are supposed to have jurisdiction over the practice of medicine. This will take the federal government even further into the doctor’s office.
- Also in this new bill, compounded “copies” of FDA-approved and marketed drugs would still be considered illegal. This would enable drug companies to raise prices on some drugs to astronomical levels.
As the Senate prepares to pass this, these very bad provisions notwithstanding, we should remember that we were successful in changing many troubling elements of the original Senate bill. For example:
- The previous version of the bill would have allowed the FDA to identify bulk ingredients not “suitable for compounding” based on “public health concerns” even if they have a USP monograph. We managed to strike the language that a USP monograph would not provide protection. Since important ingredients like estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it! This was a major victory.
- We ensured that compounders could make non-standardized dosages of drugs so you can have the right dosages instead of cutting pills in half.
- The new version of the bill maintains the standard we inserted (from current law) for “difficult to compound.” Previously the bill had no standard, giving the FDA too much flexibility to ban whatever they wanted. It also doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned.
- The provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a backdoor approach to banning compounded medicines, because everyone knows that no one could afford to pay for those trials of non-patentable drugs, and RCTs in any case are inappropriate for individualized medicine.
- We were also able to remove the requirement from the previous version of the Senate bill that doctors must substantiate the need for a compounded prescription.
- And the bill no longer sets up the impossible to measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales or require physician reporting within a few days.
We will develop a strategy for how to deal with the remaining problems in the bill if the Senate passes it as expected. As noted above, this will probably involve challenging some of it in court.
URGENT Action Alert! (1) Please send your senators another Action Alert email, and ask them to amend the Senate compounding bill immediately. Then (2) PHONE your senators on the off chance that someone is still there—use our Action Alert for your talking points. Most senatorial staffers are out since the government has shut down, so when you phone, if you don’t speak to someone in the senator’s office, call back again when the government opens back up. We cannot stress how urgent this is—please take action TODAY!