Don’t Empower the FDA to Take Away Your Access to Compounded Medications

Natural Medicine
This new legislation is a wish list for Big Pharma. Action Alert!

On April 26, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released draft legislation that would “clarify” the FDA’s ability to regulate both compounding pharmacies and the compounded medications themselves.
It’s our understanding that the draft bill was written with the specific intent of giving the FDA broad authority to remove compounded medications from the market in one of two ways: either by putting bulk ingredients on a list of “banned” compounded drugs, or by redefining compounded variations of approved drugs as illegal “copies.”
The way the bill is written, a compounded medication—like the low-cost pregnancy medicine 17P (similar to KV Pharmaceutical’s hugely expensive drug Makena), or a bioidentical estriol that can be used instead of Pfizer’s dangerous (and not bioidentical) Prempro—could be banned.
We don’t yet know who is pushing the specific language of this bill, but it is interesting to note that Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee.
There’s a silver lining, however: the bill will cost Medicare and Medicaid billions of dollars, because these programs rely on the more cost-effective compounded versions of these drugs, so there may be some serious push-back on it.
It’s possible that this bill would not only federalize compounded medications dispensed by prescription, but give the FDA authority over the state regulation of the practice of medicine! It would require that a practitioner certify on the prescription that the compounded variation produces “a significant difference from the marketed drug version.”
Of course, the mere fact that the doctor is prescribing the medicine in the first place should be justification enough—the federal government should not interfere with the practice and prescription of medicine. The FDA already tries to meddle in the practice of medicine as we have pointed out before, and certainly does not need more authority to do so!
The bill bans compounded drugs that are a “copy of a marketed drug,” but defines it so broadly that most compounded drugs could be removed from the market, thereby increasing healthcare costs and limiting patient access to important medications.
For example, as we reported in 2011, KV Pharmaceutical considered compounded 17P to be a “copy” of their drug Makena and tried to ban its production. Fortunately, after pressure from Congress, grassroots activists, and the media, the FDA finally relented. Under this new bill, 17P could be banned. Millions of women depend on access to bioidentical hormones. Critical (complete) thyroid medications that millions of American women and men depend on would also be at risk.
The bill would also ban certain veterinary medicines. Compounding pharmacies sometimes create a convenient, topical version of a marketed drug that is only available in oral form, for use on the many pets who don’t like taking pills.
Even worse, the bill would give FDA the power to disallow entire categories of drugs that could be compounded, such as “extended release products.” Compounding pharmacies currently offer time-release, complete, desiccated thyroid compounds, which can be difficult to find elsewhere. Most thyroid medications made by drug companies are not complete, and some of these important thyroid medications are never available in time-release versions.
The FDA has in the past attempted (unsuccessfully) to ban bulk bioidentical estriol at the request of a pharmaceutical company. With this bill, the ban would be much more likely. If the pharmaceutical industry were to come up with a wish list, we’d imagine banning compounded medicines would be at the very top.
It seems clear that this legislation will be presented as a response to the problems at the New England Compounding Center we told you about last October. Poor quality controls at the facility led to some steroid injections becoming tainted with a fungus—an outbreak which FDA Commissioner Margaret Hamburg conceded last month was due to lack of FDA action despite many complaints they had received about the facility coupled with “a confusing legal landscape.”
Hamburg asked for a consistent set of safety regulations that would require compounding pharmacies to report any problems associated with their drugs. Instead, it seems the bill does little to increase the safety of compounded medicines or improve facility inspections, but rather makes it easier for FDA to ban many compounded drugs altogether.
Action Alert! If you are a resident of Alaska, Connecticut, Colorado, Georgia, Illinois, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, North Carolina, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, Wisconsin, or Wyoming, please contact your member of the Senate HELP Committee and ask him or her to strike the extreme language in this bill that has nothing whatsoever to do with safety. Please take action immediately!

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  1. Compounded MEDS. do not belong in your hands. Everything the RDA and USDA touches is ruined. I have been taking a compound Med. for three years now. I have had nothing by a pleasant experience. Stay with the read Meds, and leave the compounds alone. I’m sure once the RDA regulate it’s use, it will never be t he same.

  2. I depend compounding of medicine on a regular basis. This provides me with the best treatment for the best price. Please do not allow or encourage any action that will interfere with this process.

  3. it is interesting to note that Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee.
    No more need be said

  4. This is yet another take over by the feds…………..this is shameful, I think all the drugs that are being pulled may not be dangerous, just this administration culling the medication.

  5. Please for once could Congress not be more interested in Big Pharma and their huge profits and be concerned with real people. Anyone who thinks we have such a wonderful democracy has not examined how corporations have purchased the entire government. The big problem is that any change has to come from those who have been bought. Not much chance of that happening, I suppose.

  6. Dump the FDA now!
    FDA palms greased by every drug company that comes along.
    Don’t push your approved drugs on me!
    Test them first!
    Old tyme tested and proved drugs work! Don’t tax them for real healing. Accept it! get over it!

  7. To: Senate HELP Committee
    I want you to hear how fed up I am with the FDA’s comraderie with big pharma protections, Monsanto and GMO’s, pesticides with endrocrine disruptors and killers of bees and an entire laundry lists of assaultes on the American public by government agency protection and support of what is tantamount to bio-terrorism.
    As an American citizen, I inssist on maintaining healty soils, healthy water and healthy foods. Politically, I will work to defeat any and all regardless of party who fail to support the continuation of compounding pharmacies, particularly those that practice with natural compounds without GMO ingredients.
    I am a 61 year-old former Presbyterian minister, teacher in an alternative high school, museum director and also formerly worked for a fracking company in North Dakota. I am smart, well-educated and profoundly disappointed in the cuddly relationhip our political structures have developed to mamke sure American Citizens continue to be exposed to mercury, toxic chemicals, drugs that do not cure . . .

  8. Big Pharma is flexing its muscles and with the aid and abetment of the AMA and traditional physicians they will succeed as they control Congress with their bribe monies. God help those of us who take alternative approaches to real “health”, rather than the band-aid approach of traditional medicine.

  9. All I need is an answer as to why you think Big Pharma needs more welfare.

  10. A very close loved one had gastric bypass about five years ago. Within 12 months of the surgery, she was hospitalized with two bleeding ulcers. Last year, she had to have surgery to remove two tumors from her throat (one of which was attached to her vagus nerve). Despite eating extremely small portions, it seems as though almost every meal is followed by anything from exhaustion to dry heaves to outright vomiting spells. When she’s not suffering from insomnia, she’s sleep-walking. If you’ve ever been around someone after they’d just gotten home from a 20-hour shift, that’s how she acts most of the time – exhausted, almost zombie-like. If you absolutely must go to such extremes to lose weight, opt for the lap band. Stay away from gastric bypass surgery. There are worse things than obesity.

  11. Greed Mongers keep your hand off the compound pharmacies
    The FDA/Big Pharma are filthy and corrupt and literally make me sick

  12. It is also high time to push our lawmakers to change the contribution rules. If a judge needs recuse himself from a case where he has vested interests, so also should a lawmaker fail the eligibility test where a business, to whom they are financially beholden, stands to benefit from that lawmaker’s participation in forwarding or stalling legislation. This is a no brainer and long overdue.

  13. Never allow them to stop compounding remedies. This is comparable to censorship. the people calling for the emd of compoundiung are the ones who either 1. know nothng about it or 1. will benefit monitarily from the ban. The drug companies and the FDA need to quit making back room and under the table deals.

  14. I live in AZ. Why won’t this Action Alert take my signature? I have signed Action Alerts before. I would like to sign this petition. Thx. Jude

  15. I’m curious about why only certain states are being asked to put pressure on this committee. It seems like a bigger response might bring about a better outcome. Won’t this affect all of us?
    I take four compounded medications because I had serious side effects from similar prescription drugs. I definitely don’t want restrictions to be put on these medications.

  16. People like me simply cannot afford a simple “one size fits all” policy when it comes to health care. I am one of those people for whom traditional run-of-the-mill pharmaceuticals have proven to do more harm than good, but when pharmaceutical compounds are tweaked to address my individual deficiencies, my health is restored. I do not understand the threat to big pharma about this — why do they want to limit access to medicine that is compounded to fit an individual?

  17. Big Pharma laready makes PLENTY of money off of everyone. It’s time for you to understand that compounded perscriptions are valuable and work well. Just because the FDA didn’t monitor one compunding company shown on 60 minutes, and they provided tainted compounds, is not a reason to punish the rest of the reliable comounding pharmacies out there. THe FDA didn’t do THEIR job, that’s why there were problems in the first place. This bill is like killing horses because the FDA left the barn dor open. It makes NO sense, and is most ill-advised.

  18. Please stop trying to regulate every move of Americans. Legislators are exceeding their authority and are trying to remove the natural choices of their constituents. Are you are intoxicated with your power. I am 70 years old and am frankly very concerned about the excesses of control and loss of constitutional rights.
    You have turned America into a police state, and the future for my children and grandchildren is frightening. Please stop the excessive imperialism at the cost of Americans education, earned benefits like social security and medicare which are not in financial trouble.
    Please look up the CAFR1 on Google and get informed about the economic condition of our country.
    You will see that taxation is no longer needed as the interest alone in the CAFR exceeds the cost of operating government. Start playing games with us, and acknowledge this money and get the economy moving with people spending the money they were required to pay to all government in the form of taxes. Let’s get real and honest.
    If I want compound meds ordered by my physician why would you object? For the benefit of pharmaceutical companies profits. You do not represent the corporations, as the voters outnumber them.
    I really like my representative and senators, but want to see some more openness and honesty, and less stress held over our heads by decreasing our choices.
    Thank you.
    Thank you.

  19. If the HELP committee wanted to leave a legacy of effective governance, the most useful thing they could do is to abolish the FDA and start over. Under the FDA’s aegis, there is not even an attempt at the appearance of propriety. The “science” of medicine has become corrupted to the point of uselessness. Food fraud is everywhere, from tuna fish that contains no tuna, to meat, fish and shellfish treated with chemicals that draw in and retain water,increasing weight so that the consumer is paying shrimp prices for water. This has gotten so bad that 40-50% of some food items is added water, and it’s impossible to properly saute the stuff. Thousands of people die every year from prescription pharmaceuticals, in the case of drugs like Vioxx amounting to mass murder, and no one goes to jail. Meanwhile, the FDA is busy conducting armed raids against raw milk producers. Raw milk hasn’t made anyone sick in decades. Failing abolishment, at least I hope they don’t give the FDA more power to extend the bidding of the corporations they will work for when their FDA tenure is over.

  20. FDA at it again,trying to screw the american people via or do nothing lousy corrupted bought and paid for political scumbag fasisct congress members of BOTH the left and right political parties, when will it end you ask? simple with our demise as they drain the life blood from our veins and dollars from our savings or bank accounts

  21. Would like ANH to make up faxes we could send to our congressmen.Ron Paul has had great success with allowing us to flood congress with our concerns,
    Please advise.

  22. this bill will cost Medicare and Medicaid billions of dollars because these programs rely on the more cost-effective compounded versions of these drugs.

  23. It would not be right if you interrupt my taking a certain medication being utilized all over the world for auto immune illnesses! I’ve been taking it faithfully for almost three years this month! This is wrong and there is room for both in our country! I don’t want this to take place!
    What the heck does my zip code have to do with my giving my opinion of our government interrupting or making it impossible to deal with a compounding pharmacy? If you’re going to send me information and it pertains to me, I have an opinion; especially when I use a product for almost three years that is filled by a compounding pharmacy! This isn’t fair! I have a right as a citizen who uses a compounding pharmacy to verbalize my opinion, so why wouldn’t you allow it to go through? This is disappointing or are you siding with our screwed up government?

    1. Hi Linda–Thank you for your comment. Unfortunately, the software we use to send our petitions only allows Members of Congress to receive messages from their constituents. We apologize for the inconvenience. Best, ANH-USA

  24. The bill does little to increase the safety of compounded medicines or improve facility inspections, but rather makes it easier for FDA to ban many compounded drugs altogether.

  25. It would be a huge mistake to allow the FDA to interfere with the bio-identical hormones being compounded for women or men. The precisely compounded medicine I personally have received has made a difference and improved my mental and physical health since I’ve been using them. I sincerely hope we will continue to have access to this medicine.

  26. U.S. citizens must have unrestricted access to all forms of medication, not just those that line the pockets of the pharmaceutical industry.

  27. The way the bill is written, a compounded medication—like the low-cost pregnancy medicine 17P (similar to KV Pharmaceutical’s hugely expensive drug Makena), or a bioidentical estriol that can be used instead of Pfizer’s dangerous (and not bioidentical) Prempro—could be banned.
    We don’t yet know who is pushing the specific language of this bill, but it is interesting to note that Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee.
    Please fix the bill or vote it down. Thank you.

  28. Please remove extreme language that does not have to do with safety and quality control.
    We, the people have a right to compounded medicines. It should NOT be up to the pharmaceutical companies to outlaw everything natural that competes for their consumer dollars.

  29. We did not elect Pfizer nor any other big pharma company to pay off our government officials. If we can get lower-priced and/or generic drugs, it’s exactly what we need, with NO interference.

  30. Normally, I agree with most of what comes from this website bit in this case you are so far off its like you’re in another galaxy. Compounding pansies are not going to be banned, they well be regulated just like other pharmaceuticals. This is completely necessary for public health. Your objections because of what “your understanding” of what is in the bill just make you appear to be, quite frankly, ill-informed nuts.

    1. Where do you get your information? If I, as a vegetarian, object to being drugged with say, Premarin (“Pregnant Mare’s Urine”) then I should be allowed to do so. Compounding Pharmacies are probably more careful than most drug manufacturers out there. And, those of us who use Compounded prescriptions pay sometimes 4-5 times as much for the “privilege” of using natural remedies, because our Insurance does not cover compounds.
      Pardon me for saying this, but you sound suspiciously like someone involved in either Big Pharma or conventional medicine. Don’t be threatened. Be glad that there are those out there who are honestly concerned about the health of their fellow human beings.
      P.S. Check the stats on how many people die each year from prescription drugs. Not accidental overdoses, or those illegally obtained, but from drugs prescribed by doctors who don’t check for interactions, too many different drugs, or over prescribing. All doctors require us to fill out a form, listing each and every drug we are taking, including vitamins. Yet, they just pile on another drug as if the list didn’t exist at all. It’s very difficult to over dose on a natural remedy.

  31. If the FDA is successful they will ruin my health completely. If they are looking out for our health, then why are they backing BIg Pharma at every turn at the expense of the health of the individual? Is money more important than life? The FDA is increasingly making people wonder that very question and if so who is minding the store? And don’t get me started on GMOs, more proof that health is less important than money.

    1. I mean no disrespect by this comment, but how can you ask if money is more important than health? If you take a look at every system in our government, you can see that money is OBVIOUSLY more important than not only health, but everything else. Since our health is at the bottom of every other thing we are and do, we need to stand up for our right to eat good food, breathe clean air, drink clean water and live like decent human beings.
      Big Pharma has poured billions of dollars into the “Health” system of this country to the point that it’s getting difficult to opt for the natural version of almost every drug on the market.
      If for not reading the pamphlet that comes with every prescription drug on the market, I would be dead right now. I have spent the last two years weaning myself off of the deadly cocktail of drugs that the Medical community had me taking, in spite of the warnings on every label. Be Informed. Be Non-Violent (except when your life is being imminently threatened) Be relentless.

  32. Compound drugs are vital in many cases. Finding a pharmacy that produces them is difficult. I would have been in big trouble if my physician had not been able to find a compounding pharmacy that would create a cream for my skin condition.
    Please don’t let Big Pharma encourage you to stop compounding pharmacies. It’s a matter of greed for them and health for the rest of us.

  33. compounding pharmaciesprovidea needed and valued service that cannot be obtained by any other means.

  34. the only way i am able to live is a half decent life is due to Two compounded meds!!!!!!!!!

  35. Big money and greed lead to inappropriate power grabs. And that is just what is happening here. And, that is the stuff that dictatorship is made of. It’s all founded based on money, and power….
    The pleas on this forum for access to medication (for heaven’s sake!) indicates how dictatorship and government-encroached boundaries harm the people.
    It’s time for us to call this what it is. It’s dictatorship, not merely access to medications or supplements that we are talking about here. Let’s please call them out on this one, and call a spade a spade.

  36. Congress and FDA apparently have no goals that align with the health of the American people.

  37. I have a suggestion for everyone — as a political activist I’m familiar with “armchair lobbying” — calling and emailing on issues.
    As ANH noted, the senators on the “HELP” (helping whom???) Cmte place a lot more weight on hearing from THEIR constituents. Why, you might wonder? Because most politicians want to be reelected, so it has a lot more weight coming from a constituent.
    What I recommend is that you CALL the DC Capital switchboard (24/7) and asked to be “transferred to the Senate’s HELP Cmte” — if they don’t know what that committee acronym stands for, be sure to have it and spell it out (as noted above). Many times if they don’t know, they just transfer your call around, which is annoying. EVERY AMERICAN SHOULD CALL ***EVERY*** ELECTED OFFICIAL, SENATE OR HOUSE, AND VOICE YOUR OPINION!!!” This “cmte” represents ALL AMERICANS, but as stated above, these politicians are always thinking about reelection. Ring their phones of the hook. Their aides will be sure to tell them of your call. They keep a log of “yea’s and nay’s for particular bills. Also know that I often call senators and rep’s that are NOT my elected officials representing my district and I use call block (*67) and just keep it brief. Tell them I’d like the senator (or rep) to Support or Oppose Senate bill #_____ of House Bill #_____ and then ask them to please be sure that the senator gets my feedback. I’d say at least HALF of the time, they do not ask your zip code or address, but when they do, I always tell them the truth. Also, do the same for these elected officials DISTRICT offices.
    Again, remember, they mostly just keep a log of yea’s and nay’s — so calling helps. There is a lot of turnover of aides, many interns who are clueless, and are overwhelmed by the large volume of calls. They want to get you off the line, so the more to the point you are it’s more likely your feedback will get through. SILENCE IS THE VOICE OF COMPLICITY!!!
    Find your elected officials at all levels of gov’t at non partisan website:
    Get involved, or don’t complain!

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