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.
oppose S.959
I am asking you to oppose S.959.
Thank you.
Please oppose S.959.I use and have been greatly helped with bioidenticall hormones.
Thank you,
Pam Smith
Who wrote the letter to legislators here?:
https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=1624
It is a personal letter saying I will suffer i Estriol is not available. I am a man. I have no use for Estriol. This letter should be proofread and fixed.
Don’t pass senate bill S 959 !!!!!!!
We want the right to make decisions on our own health!
Oppose S.959! Thank you.
I have no medical insurance due to “pre-existing” conditions. I want to pay for health insurance and no one will give it to me. I am healthy, perfect weight and have no discernable health problems. I can afford the compounding estriol for MS and cannot afford the synthetic interferon solutions for MS. Please do not take away what works for me and at a price that is affordable. The Women’s Pharmacy in Madison, WI is an reputable company that my neurologist highly recommends. Do not punish the good because of the bad. Please do not pass this bill. My health depends on it. Thanks for any help that Senator Rubio, Senator Nelson and Representative Lois Frankel can give a Floridian resident. Susan
I am grateful for this newsletter, which informs me of issues and upcoming congressional actions which I would otherwise not learn about. Many of these issues impact my life profoundly, and I am pleased to be able to add my name and/or opinions to the letters or actions the Alliance is planning to act on. Thank you!
PLEASE OPPOSE S.959!! Please do not limit citizens right for medical care to only one form of medication that is made by a big pharmaceutical company. I do not believe that the drugs they produce are always the best for me; compounded drugs have worked much better for my body and I believe I am healthier because of them. Please do not ban bioidentical estriol.
Please let the American people use their own intelligence and make their own personal decisions about health care.
Please!!!!
Please do not take away consumer freedom of choice.
please don’t take away concumer freedom of choice.
I personally want the government out of my personal medical business. The only issues the government should consider at all, are issues of safety and of criminal actions that could involve the selling of controlled substances across state or international lines for the purpose of addicting or poisoning our population. Let the physicians and the pharmacies do their work with a minimum of unneeded and unwanted and unnecessary regulations so they can get their job done without bureaucratic and political harassment.
Why do you require folks who want to support your action to go through an application that want to have your Facebook profile and friends list. Sorry but that is invasive and many people do not want to give up this information to a third party company. Why not give people an option to help.
Thanks,
JSM
Compounded medicines are an important piece of good medicine. They improve quality of life for patients. Please do not take them away fom providers.
Here’s what Senator Michael Bennett in Colorado wrote back on the compounding issue:
Thank you for contacting me regarding the Pharmaceutical Compounding Quality and Accountability Act (S. 959). I appreciate hearing from you on this important topic of compounded medicines.
As you may know, in October 2012, an outbreak of fungal meningitis occurred in the United States which led to more than 50 deaths and left another 700 people severely ill. The bacteria that caused these infections were found in medications used for epidural steroid injections, which were produced in a compounding center in Massachusetts. Inspections of other compounding locations discovered numerous problems with how drug compounds were being manufactured and packaged.
On May 15, 2013, Senator Tom Harkin (D-IA) and Lamar Alexander (R-TN) introduced S. 959, which aims to clarify and improve oversight of the compounding process, and act as a safeguard against a similar event happening again. S. 959 was passed out of the Senate Health, Education, Labor, and Pensions Committee on May 22.
This bill attempts to divide accountability between states’ role in regulation of traditional pharmacies that compound medicines and federal oversight of large-scale compounding manufacturers. The bill also seeks to preserve traditional pharmacies’ model of being primarily regulated by the states without impeding patient or provider access to prescription compounded medication.
As the Committee works to address concerns from various stakeholders about the Pharmaceutical Compounding Quality and Accountability Act in the coming weeks, I certainly will keep your thoughts in mind.
I value the input of fellow Coloradans in considering the wide variety of important issues and legislative initiatives that come before the Senate. I hope you will continue to inform me of your thoughts and concerns.
For more information about my priorities as a U.S. Senator, I invite you to visit my website at http://bennet.senate.gov/. Again, thank you for contacting me.
Our elected officials do not represent this country or it’s people, they represent their own interests and special interests who support them. Judgment day is coming, I pray they will see the light before it gets here.
Say YES to Compounds-let us have our choice and freedom to choose our supplements. It is more affordable at times to use compound supplements rather than purchasing several individual bottles. The people should have the choice.
Please oppose S.959.
Please do not take away this necessary option for those of us that rely on compounded medicines.
Coalition Letter Against S. 959
Jul 9, 2013
Coalition Letter Against S. 959
As advocates for patients, including the unborn, we oppose U.S. Senate Bill S.959 due to its very harmful impact on the ability of pregnant women to obtain affordable medication that protects against premature birth. We also oppose S.959 for how it would vastly expand the power of the Food & Drug Administration (FDA) to write new regulations, which would likely include new interference by the FDA with adult stem cell treatments.
Because of this anti-patient, anti-life impact of S.959, several of the undersigned groups will “score” the vote on S.959 as part of their congressional scorecards. A vote for S.959 will receive a negative score by these groups. This bill was originally intended to address a meningitis outbreak that was traced to contaminated steroid injections made by a compounding pharmacy, but S.959 has morphed into something very harmful to patients and the unborn. S.959 epitomizes the concept of “never let a crisis go to waste,” as it exploits a meningitis outbreak to push an anti-life agenda.
Elimination of Affordable Medication that Prevents Premature Births
Specifically, S.959 eliminates access to affordable medication essential to safeguard against premature births. A significant percentage of pregnancies are prone to premature birth, which often results in deaths of the unborn children or severe birth defects. Some women have abortions when told that premature birth is likely, especially when they lack access to affordable medication to safeguard the pregnancy. A medication exists to help prevent these premature births: 17 alpha-hydroxyprogesterone (“17P”), which is a synthetic form of the female hormone progesterone. Compounding pharmacies currently provide this medication at an affordable cost to thousands of pregnant women who are prone to premature delivery.
Despite the fact that compounding pharmacies have been providing 17P at an affordable cost for over a decade, S.959 contains provisions that greatly expand the definition of “copying” which would effectively prohibit compounding pharmacies from making this and other FDA-approved, but non-patented, medications. One drug manufacturer produces this (non- patented) drug, at an astronomical list price of $690 per injection per week, totaling $13,800 per pregnancy. Compounding pharmacies currently provide this same medication for $15-$20 per injection per week, totaling only $300-$400…
Please oppose the bill S 959 in which the FDA is trying to limit and in fact eliminate the compounding of drugs and mixtures of drugs by compounding pharmacies. The examples I’m most familiar with are the natural hormones, such as estriol, progesterone, etc. that have been compounded for many years and supplied at a reasonable cost to patients. The drug companies want to get their own versions of these approved by the FDA so that they can get in on this potentially lucrative market. This market can only be lucrative if the FDA stamps out the compounding of these natural products. The net result will be enriching the FDA and drug companies (yes the FDA gets funding from the drug companies) at the expense of the ordinary citizens. You have shown an interest in supporting freedom and liberty and opposing big government. It would be natural for you to oppose this bill.
Please do not take the only hope away from folks who depend on compound medications to cure their illness. Millions of people look upon you for your just decision. Thank you.
Please do not let this bill pass. This will take the ability away from many women to get bio identical hormone replacement. I have had blood clots in my legs from synthetic hormones. Without bio identical hormones I will have to suffer thru menopause without any viable treatment. This also will eventually lead to natural dedicated thyroid to be removed from the shelves as well. Synthetic thyroid hormones almost killed me. Natural have given me my life back. Please don’t let this bill pass.
Please do not pass this motion!
Compounded thyroid changed my life for the better, none of the other medications could get me stable. This is not uncommon, many do BETTER on natural compounded medications. Please give all of our physicians and pharmacists ease in flow, not barriers.
Thanks,
Dr. Jessie Keener
I can NOT even try to imagine trying to get through a DAY without my Estradiol, Testosterone and Progesterone, my Enhansa and my Nature-throid….
When you consider the thousands that are harmed or killed by pharmaceuticals that are approved and taken as directed, this bill is laughable. Bio-identical hormones should be protected. They are the most effective. Compounding is necessary for some who have allergies. Common sense protections are all that are necessary.
Dear Sen. Heller,
I have previously written to you regarding S 959. Please do not vote for this revamped bill. My husband and I are both on Tricare, which is artificially already limiting compounded drugs. We use only compounded drugs due to health concerns of the many side effects of patent drugs. This is the equivalent of deducting over $1500 per year from our Tricare benefit, which my husband earned through his military service.
Your previous letter was very vague on how you would vote on this issue.
Believe me, your voters count on you to vote in their best interest and don’t forget when the next election rolls around.
Thank you for considering this issue.
Pamela J Gillick
I cannot get your server to take action – happens too much of the time
I demand access to bioidentical hormones, non-standard thyroid medications, and other compounded medications.
Please oppose S.959! So many people have died over the years using synthetic medications with all of their horrific side effects. Please take into account all of the lives’ that have improved since using the natrual compounded versions of synthetic medications. Natural is always healther than taking loads of synthetic chemicals. It seems the FDA always wants to get involved when it knows there is big money to be made by the Pharmaceutical companies. Please help stop this madness and protect our rights as human beings to be able to choose what medications works best for us. Only the people can tell you what works best for them, not the FDA. I’m afraid to think how I will be feeling if the bio-identical hormones and thyroid compounds that I have been taking for 4 years are removed. Please oppose S.959!
Please oppose SB959. Compounding pharmacies serve women who need bioidentical hormones. Do not take away this choice for women by eliminating compounding pharmacies. Synthetic hormones have serious and unwanted effects on a woman’s body.
Please oppose SB959.
OPPOSE THIS BILL!!!! Pay Attention to what is at stake!! Think!! America the Beautiful not some Totalitarian State!
I know that I am not alone in the restorative medical benefits I have received using compounded medicine. I simply cannot tolerate Pharmaceutical Drugs. After severe ADR from a popular drug which left me in a wheelchair and crutches, completely altered my ability to detoxify.,….I am forever grateful for the grace that God gave us by creating medicinal plants etc. I have done the genetic tests that show, I cannot detox Pharmaceuticals.. It induced an autoimmune disease which has me even more reliant on Compounded Medication for my LIFE!
This totalitarian trend of oppressing the people, AND CONFISCATING OUR RIGHT to NON Toxic medicine is just Barbaric and ultimately foolish for All of us. This onslaught of beaurocratic red tape, is not healthy for this country whether you personally use Compounded Medicine or not.
This frightens me! What about infants that are born with heart and other health complications that cannot get the medication they need for their survival in anything other than a tablet or capsule??