The Alliance For Natural Health

Congress Passes Compounding Bill—Still Flawed But WITH Your Hard-Won Amendments

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caphillTechnically it was a “unanimous” voice vote. But they didn’t keep a tally, so there’s no record of which senators didn’t vote at all.

 

Yesterday, by acclamation, the Senate passed the compounding legislation that Congress has spent months considering. The problem is that with voice votes, only a certain number of senators need to be on the floor of the Senate at the time of the vote, and then there is no official tally. Shamefully, our senators are able to vote for the bill or abstain altogether, and no one is able to hold them accountable for their actions.

 

In addition, the bill that came out of committee was simply replaced at the last moment with a completely new bill. This new bill was presented as a “fix” for the problems of the old bill, but whoever drafted it took the opportunity to sneak in new language that nobody had previously approved. Since this was supposed to be the “fix,” no additional changes were allowed, despite the presence of new provisions.

 

Serious concerns remain about the bill, which ANH-USA has opposed from the start. However, it was your incredible grassroots activism—your willingness to call and send messages to your members of Congress over and over—that ensured the final bill contained important amendments:

 

  • The previous version of the bill would have allowed the FDA to identify bulk ingredients that are allegedly 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 bioidentical 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.
  • The new version of the bill maintains the standard we inserted (from current law) for the definition of “difficult to compound.” Previously the bill had no standard, giving the FDA far too much freedom—it would have let them ban whatever they wanted. Importantly, the language no longer includes time-released medications among those deemed “difficult to compound” and therefore potentially banned.
  • The provision that compounders needed to perform random controlled trials (RCTs) 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 or off-patent drugs, and RCTs in any case are inappropriate for medicine that is—by definition—individualized as compounding is.
  • 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.
  • 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, as well as the provision requiring physician reporting within a few days.

 

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.

What’s still wrong with the bill? It 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. 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. Another section of the bill makes compounded “copies” of FDA-approved and marketed drugs illegal. This would enable drug companies to raise prices on some drugs to astronomical levels.

We’ll monitor the FDA’s rulemaking process (that is, how they’ll implement the legislation), and we’ll be sure to notify you of problems and opportunities for comment and action.

 

Time and time again, you’ve proven that through your unyielding activism and our combined strength in numbers, we can make a difference in Washington. Thank you again for your hard work on this bill.

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