Sadly, the Drug Quality and Security Act is a deviously misnamed attempt by big drug companies to put its competition out of business. It became law on November 27, 2013, after being signed by President Obama. Unfortunately, it seems Congress, influenced by big pharmacy’s big lobbying dollars, wanted to make the appearance of repremanding the FDA for it’s failure to shut down one, grossly negligent compounding manufacturer—but in reality took advantage of the opportunity to give the FDA vast new powers to limit or shut down all compounding pharmacies and the doctors who prescribe the natural medicines and Bio-Identical Hormones that they make.
In the fall of 2012, fourteen thousand patients received a compounded, injectable medicine made by the New England Compounding Center (NECC). These spinal injections were contaminated with with a fungus that caused meningitis. Over 700 people were sickened by this contaminated drug; fifty-three died. This tragedy could have been prevented if the FDA had enforced the regulations it already had power to enforce in this rare, isolated occurrence.
In 2002, the FDA began investigating Massachusetts’ NECC after receiving reports that five patients had become ill after receiving its drugs. The FDA inspected the NECC in 2004. Two years later, it issued a warning letter based on violations it found during its inspection. In 2008, FDA received additional complaints but the FDA declined to take the steps necessary to correct the problem and instead merely sent another warning letter. The FDA had the power to act but didn’t.
Never let a good crisis go to waste
In the wake of the meningitis outbreak, Big Pharma lobbyists exaggerated the issues and extended the concerns to all compounding pharmacies and their medications. Unfortunately, Congress found a willing audience: on April 26, 2013, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released compounding legislation that rewarded the FDA’s ineptitude and inaction with expanded powers. The bill:
- Granted the FDA the power to remove most compounded medications from the market—which could summarily eliminate natural medicines like bioidentical hormones and clear the way for more expensive patented drugs;
- Outlined a standard for compounded drug safety and efficacy that would have required double-blind, random-controlled trials (RCTs)—a standard typically reserved for mass-produced prescription drugs!
Interestingly, that same month, the House Energy and Commerce Committee concluded that the FDA was at fault for the NECC tragedy: “After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA…We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families.” How can one reconcile the stark difference between the conclusion of the Senate investigation (that the FDA had ample power and choose not to act) and the April 2013 legislation (that the FDA needs more powers in order to act)? Three simple words: Follow. The. Money.
- Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee.
- In May 2013, the Working Group on Pharmaceutical Safety went public, revealing one of the most influential behind-the-scenes forces behind the HELP committee’s legislation. WGPS is headed Tommy G. Thompson, former US Secretary of Health and Human Services (HHS) and current chairman of TherapeuticsMD, a founding member of WGPS.
- In July 2013, ANH-USA obtained a document in which TherapeuticsMD, pitching itself to potential investors, named compounding pharmacies as competitors in the coveted bioidentical hormone market.
The final bill, which was passed in November 2013, was revised to eliminate several troubling elements of the bill, thanks to pressure on Congress from many thousands of patients and Integrative Medical Physicians. However, many concerns remained. For example, the alarming distinction between traditional compounding pharmacies and outsourcing facilities: traditional pharmacies will only be able to compound drugs that have a USP monograph, are part of an FDA-approved drug, or are on a “pre-approved” FDA list, and will only be able to send 5% of their total prescriptions out of state. By comparison, outsourcing facilities will be permitted to distribute out of state without restrictions and won’t require individualized prescriptions. However, in order to become an “outsourcing pharmacy, they will have to pay the FDA upwards of $1,000,000 and they will only be able to produce drugs that are on an FDA-approved list (it’s likely this list will be limited as well and could be changed on a whim at any time by the FDA). The full impact of the final bill will not be known or felt until the FDA completes its rulemaking process. However, after carefully analyzing the legislation and speaking with compounders and doctors, we project a number of ramifications:
- Fewer compounded drugs may be available. Drugs like bio-identical Estriol, or Testosterone, compounded IV nutrients, and desiccated (complete) thyroid medications, may be banned from outsourcing facilities under new FDA rules.
- Because traditional pharmacies will be limited in how many drugs they can compound for out-of-state patients, and doctors will be less able to order drugs for office use in advance, patients may have to wait longer for the drugs they need.
Rising Costs of Compounded Medications
On September 30, 2014, the FDA closed its short 3 month public comment period and is now finalizing its list of approved and unapproved drugs and specific compounding pharmacy regulations. Nevertheless, the Compounding law has already begun to have its desired effect. Prices for Compounded Medications have already risen 300-600% due to the additional costs created by the legislation.
- Compounding Pharmacies can no longer sell Bio-Identical Hormones in bulk to doctors office’s.
- Each formulation must be prescribed individually for a specific patient
- Each compounded medication must be made individually by hand for each patient
- Supplies of Compounded Medications are limited by the FDA to 5% of their total prescriptions out of state
- Massive increases in time and paperwork must be employed to prepare and track each new prescription
- Additional administrative and legal fees will be required to meet these oppressively burdensome new regulations
The bottom line is that “Big Pharma” is taking advantage of an isolated tragedy to squeeze “little compounding pharmacies” and the doctors that use their products out of business. As a Naturopathic Physician and a Diplomat of the World Society of Anti-Aging Medicine, I am one of the few Physicians who who is medically trained in and prefers to prescribe Natural Medicines and Bio-Identical Hormones rather than synthetic, patented drugs. Why, because they work and they are better for my patients. When Congress and Big Phama say they know better, what they are really saying is, “We want more money.” Don’t let them take away your freedom of choice for Natural Medicines and Bio-Ideintical Hormones.
Reform FDA Campaign Overview
The corrupt governmental agency that says it’s “protecting and promoting your health” is directly responsible for the deaths of 50,000 Americans each year. We believe that the FDA is a broken agency that needs a complete reform and restructuring. Join us in calling for a complete overhaul of the US Food and Drug Administration! 