The reworked version of the bill is nearly four times longer—and is even more of a threat to your access to bioidentical hormones, non-standard thyroid medications, and other compounded medications that millions of people rely on. Action Alert!
S.959, the compounding bill we’ve been telling you about, has been rewritten, and it’s now 189 pages long, up from its original 50 pages. It’s technically a substitute bill in the form of an amendment. This means that when the old bill comes to the floor of the Senate, there will be a motion to substitute this new version. It will likely all happen very quickly—as early as tomorrow. There is a big push to get it through the Senate before the August recess on Friday. That’s why your immediate action is urgently needed!
Several new provisions in the bill are especially troubling. For example, in this new draft, traditional pharmacies that do compounding for doctors’ office use will need to limit their compounding to no more than ten percent of the products they dispense in any thirty-day period! In addition, compounders must receive, within fourteen days, the name of each patient who received the compounded medication.
This is an administrative and logistical nightmare. First, the number of a doctor’s patients given compounded prescriptions in the office will almost certainly ebb and flow; it’s unlikely they will neatly fit the ten percent cut-off within the rolling thirty-day period. And to place arbitrary restrictions on how many of one’s patients can receive a particular medication interferes with the practice of medicine, to put it bluntly.
Furthermore, in the states that allow for the office use of compounded drugs, there are no such requirements. So this law will override the state laws currently in place. On top of that, having to match each patient, by name, to the compounder that supplied the medication, and do so within fourteen days, would be logistically difficult if not impossible. The drafters of the bill realize this. Their intent must be to eliminate this use of compounded medication indirectly by making it so difficult to comply.
In another provision, “compounding manufacturers”—a term that includes any compounder who ships by interstate commerce—will only be able to compound those non-sterile drugs that are included on a list to be developed by the FDA. In other words, these drugs must be pre-approved. You can be sure the FDA will create this list with an eye to ending competition with drugs that the agency has approved.
On top of these new difficulties, our previous concerns remain:
- Bulk ingredients. The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public health concerns,” which is an impossibly vague standard. FDA has attempted to ban bioidentical estriol because of such “health concerns” even though it has a USP monograph!
- “Copies of drugs.” Compounded versions of FDA-approved drugs may be banned as “copies” of the drugs depending on how strictly that term is interpreted. This could eliminate access to the much less expensive 17P in favor of the FDA-approved Makena drug. Remember that pharmaceutical companies view compounding pharmacies as a threat to their market share. On the upside, the new version of the bill says that if the FDA-approved drug is in short supply, a pharmacy can compound the drug—it only needs to provide one notice per year. Of course, “short supply” has to be defined by the FDA.
- “Difficult to compound.” The bill allows the FDA to disallow entire categories of drugs that are supposedly “difficult to compound,” and specifically names “complex dosage forms” as an example. This targets products such as extended-release products and transdermal patches (for example, many consumers rely on time-release thyroid medication, which is not available in standard drug form).
Some small victories, however: in the previous version of the bill, there was no clear definition of what “difficult to compound” really meant. We had requested that bill include language that exists in current law, and at least use a standard based on safety or effectiveness. In the new version of the bill, 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 got them to remove the provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard, as well as the requirement that doctors must substantiate the need for a compounded prescription.
What this means is that your messages are working! Your legislators really do listen to you.
There is conflicting information on when the bill will come up for a vote. Last week our sources indicated it wouldn’t come up until after the August recess. Yesterday, however, we heard that it might come up for a vote as early as tomorrow. The bill’s Senate supporters are pushing hard for a floor vote before the August recess, whereas Sen. Coburn said that more time was needed to review the new language and have industry weigh in.
No time to lose, then! If this comes up for a vote this week, the Senate needs to hear from you TODAY! Your message is simple: ask your senators to oppose S.959.
