Proposed Senate Bill 959 Is Likely to Severely Limit Your Healthcare Options and Your Reimbursement.
In the wake of last year’s tragic outbreak of fungal meningitis, which was traced back to medications manufactured by New England Compounding Center, the U.S. Senate will soon be considering Senate Bill 959.
Unfortunately, this bill does not address patient safety or the quality of compounded medications in the U.S. Instead, it puts in place a number of provisions that are likely to limit your access to individualized medications and to increase the cost of those which are produced.
Here’s an example. Every medication dispensed by a compounding pharmacy like ours is created specifically for the unique needs of that patient under a doctor’s orders. The proposed Senate bill treats each compound created in this manner as a new drug.
Not only does this give the FDA unprecedented ability to interfere in which medications a patient may or may not have, it also makes it much more likely that insurance companies will not want to reimburse you for those medications.
The FDA will also have broad new powers to place certain APIs (active pharmaceutical ingredients) on a negative list that prohibits their use if it decides they are not effective. This means that an ingredient that has worked well for you may be made unavailable — not because it isn’t safe, but simply because it has not gone through an expensive and time-consuming process to prove that it has the same effect for all patients.
In addition, the bill proposed that the FDA create a list of “demonstrably difficult” compounds, which will further limit what medications are available to you. They will also have broad authority to label and regulate a traditional, local compounding pharmacy as a “compounding manufacturer,” even if they are only engaged in the traditional compounding of individual medications as prescribed by a physician.
In short, the FDA will now be able to tell your doctor and your compounding pharmacist what medications you may or may not have.
How Does This Affect Me?
Compounding pharmacies work with your doctor to create very personalized medications under strict laboratory conditions. Who benefits from compounded medications like these?
Patients who are living with pain from arthritis, cancer or other conditions. Children with autism spectrum disorders. Women trying to manage the hormone imbalances that come with menopause. Adults and children who are allergic to one or more ingredients in manufactured medications, or who cannot tolerate the standard dosage. Anyone who has difficulty swallowing certain pills or other prescribed drugs. Even pets who require specific medications but can’t (or won’t) swallow them.
The irony is that S.959 gives so much power to the FDA, even though that agency failed to move aggressively against NECC when earlier violations were noted. Had the FDA acted more promptly and decisively in those earlier instances, last fall’s tragic outcome might have been vastly different. Instead, the FDA is now poised to gain even broader authority to restrict your access to the medications you and your family may need while increasing the cost of obtaining those medications.
Currently, the FDA is charged with making sure that the ingredients in all prescriptions are safe, while the state Boards of Pharmacy oversee the operations of individual compounding pharmacies. This system is very effective when each organization does its part.
In addition, the U.S. House of Representatives has drafted a bill which addresses patient safety and the quality of compounded medications without limiting a doctor’s ability to prescribe for you, without restricting the availability of compounds that have enormous benefits for you and others, and without affecting the reimbursement you receive from your insurer.
What Can I Do?
It’s simple. Go to www.protectmycompounds.com today. From there, you can easily send an e-mail urging your Senator to vote against S.959. You can also spread the word via e-mail, Facebook and other social media.
But act today, before the Senate enacts this flawed bill and compromises your access to quality, affordable medicine!