We’re still talking with our allies on the Hill to get more improvements, but we need your help to make sure your rights are protected. Action Alert!
We’ve been telling you about the Senate bill that places bioavailable estriol, so important to millions of women, and other important natural compounded medications in grave peril. Now the House of Representatives has released its own compounding bill, HR 3089.
It is likely that the Senate version will pass very soon, and the House bill won’t be far behind. We have heard from our allies on the Hill that there is very strong bipartisan support to pass a compounding bill this session. But you know what George Carlin said about the word “bipartisan,” don’t you?
The House bill is much better than the Senate bill, which is all about giving freebies to Big Pharma under the pretense of making compounding safer. Very importantly, the House bill does not endanger estriol. We are very grateful to our congressional ally, Congressman Morgan Griffith (R-VA) for that. However, there are still some areas of major concern in the House bill, and we are working on Capitol Hill to address them:
- As in the Senate bill, compounders must receive the names of patients who received compounded drugs “for office use.” But in the House bill, they have only seven days to obtain them instead of the Senate’s fourteen days. Logistically and administratively, this is a nightmare.
- Compounded versions of FDA-approved drugs may be banned as “copies of FDA-approved drugs” depending on how strictly that term is interpreted. As in the Senate version, the House’s definition is far too broad, and we fear that it could eliminate access to much less expensive pregnancy medications such as 17P in favor of outrageously expensive FDA-approved drugs like Makena, which costs $690 per dose, or as much as $14,000 over the course of a pregnancy. We are working to tighten the language as to what qualifies as a “copy” of a drug.
- The bill prevents pharmacies from compounding non-standardized dosages of commercially available, FDA-approved drugs. This means that consumers are left to play with the dosages of drugs on their own (such as cutting a pill in half), instead of receiving an accurate, tailor-made dosage from a compounding pharmacy.
- The bill makes the falsification of a prescription a federal criminal act. This may not seem controversial until you realize that prescriptions fall under the practice of medicine, which is regulated by the states, and making such a law allows the FDA to interfere in states’ autonomous practice of medicine. This is especially ominous in light of our recent article highlighting the collusion between state medical boards and the FDA.
Meanwhile, the Senate version of the bill remains the biggest problem, for the following reasons:
- Limits office use: The bill says pharmacies can compound only 10% of the products they dispense each month for doctors’ office use. And compounders must receive, within fourteen days, the name of the patient who received the compounded medication. We are working to get the bill amended to remove the limitations on compounding for “office use” and increase the amount of time pharmacies have to reconcile patient records with the compounded drugs from fourteen to ninety days.
- Bulk ingredients: The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public health concerns” even if they have a USP monograph which, under current law, is sufficient to allow compounding. The FDA has already attempted to ban bioidentical estriol based on vague “health concerns.” A USP monograph provides ample evidence of safety, so there is no reason it should be overruled in the government’s misguided effort to ban bioidentical estriol.
Let’s keep in mind that the FDA-approved drugs whose monopoly the FDA is trying to safeguard are not bioidentical and have been proven by extensive medical research to be very dangerous for women, specifically representing heart and cancer risks. The FDA is not a department of Big Pharma. And this kind of behavior is really reprehensible when the risks of the FDA approved drugs are at this point settled science and beyond dispute.
- “Difficult to compound”: The bill allows the FDA to disallow entire categories of drugs that are supposedly “difficult to compound,” and specifically names extended-release products (i.e., time-release thyroid medication) and transdermal patches. We are working to remove extended-release products and patches from this classification. Millions of patients rely on these products, which would simply disappear.
- Places limitations on selling out-of-state compounded drugs: Pharmacies that compound for interstate commerce face stricter scrutiny from the FDA. This could affect everyone, but especially those who do not have a compounding pharmacy within their state that can supply all their needs. Those of us on the ANH staff who use compounding pharmacies often have to go out of state to find what we need.
We have already been successful in making some very positive changes to the Senate bill because of the thousands of messages from our readers and grassroots activists like you, together with our meetings with Capitol Hill decision-makers. We got lawmakers to create a standard for the phrase “difficult to compound” so that FDA is forced to meet a burden of proof before they limit consumer access to medications based on this provision. Specifically, we included language that exists in current law: compounding must be “reasonably likely to lead to an adverse effect on the safety or effectiveness of that drug or category of drugs, taking into account the risks and benefits to patients.” We also made sure that the provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a real “poison pill” in that no one could afford to pay for these trials. Such a requirement would have inevitably led to the disappearance of many compounded medications, as the FDA (and the drug industry) know well. We were also able to remove the requirement that doctors must substantiate the need for a compounded prescription. This was another gross federal interference in the practice of medicine, which is supposed to be regulated by the states.
As you can see, there is still a lot of work to be done on this bill on both sides of Capitol Hill. Action Alert! We need to flood both the House and the Senate with emails, highlighting our various concerns over each of the bills. Please send your messages to Congress today, even if you sent a message about the Senate version previously!
Action Alert to the House:
Action Alert to the Senate: