Please help us get Sen. David Vitter’s critical amendment passed! Action Alert!
As you know from our continuing coverage, the FDA has been issuing rules to implement the Drug Quality and Security Act (DQSA). This legislation was passed by Congress in 2013 in response to a meningitis outbreak in 2012 involving a single bad actor—a compounding facility in Massachusetts about whom the FDA had received numerous complaints (though the agency took no action other than sending a warning letter to the facility).
Panicked legislators nearly destroyed compounding as an alternative to conventional drugs—something that would eliminate competition for the biggest drug companies, which is why the DQSA seems to have garnered support from Big Pharma allies at the FDA. We were able to amend the law and help save compounding, but some very bad provisions remain. As a result, ANH-USA has been closely monitoring the FDA as it releases drafts of its new rules and guidance documents pertaining to this law.
Compounding, in many cases, is the only way for consumers to access a number of important natural medicines, or to take those medicines in more natural ways. For example, a number of hormones should not be taken orally, but only transdermally. Drug companies and the FDA simply ignore this.
Compounding is important for other reasons as well. In particular, it allows doctors and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat an individual patient. Perhaps the medication needs to be gluten free or in lower dosages. We are all different; medicine should never be one-size-fits-all.
We have two main points of contention with the new FDA rules on compounding:
“Office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances, a doctor would need to have a reserve supply of the compounded drugs on hand. This enables doctors to provide immediate relief to ailing patients who come into their office, or to have a ready supply for patients whom they have a long history of treating.
For decades, the regulation of “office use” was left up to state pharmacy boards, and most state boards allowed physicians to keep a supply of compounded drugs on hand without prescriptions, recognizing that patients’ well-being depended on it. This changed with the passage of the DQSA.
Congress’s intent was to give the FDA clearer authority over compounding, and it did so by enacting an amended version of Section 503(a) of the Food, Drug, and Cosmetic Act. Congress essentially told the FDA to start enforcing the rules that were already on the books; the DQSA is completely silent on the issue of office use. The FDA, however, immediately indicated it would apply the DQSA in a way that would eliminate office use.
This apparently came as a surprise to some legislators, who wrote a letter to the FDA reiterating that it was Congress’s intent to leave office use up to the states. In a written response, the FDA was resolute in its decision: “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.”
As you might guess, this has caused a tremendous amount of confusion in the medical community and among many state pharmacy boards that have historically allowed office use. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use.
A new amendment from Sen. David Vitter (R-LA)—the Saving Access to Compounded Medications for Special Needs Patients Act—clears up the confusion by amending 503(a) to unambiguously allow office use and preserve the ability of doctors to promptly and effectively treat their patients.
Interstate Commerce and the Memorandum of Understanding
Traditional compounding pharmacies are only allowed to ship 5% of their sales per month out of state, unless they enter into a memorandum of understanding (MOU) with the FDA. The law does not define the limit once a pharmacy has entered into an MOU, but the FDA has created a threshold of 30% in their new rules.
These limits are completely arbitrary and having nothing to do with the safety of consumers. If 30% is safe, why isn’t 10%, or 20%? Is 31% suddenly unsafe for consumers? Is 50%? Additionally, how can a pharmacy be sure that it has not or will not exceed any specific percentage until the end of the month, when it’s too late to do anything about it?
In addition, many states will refuse to sign an MOU with the FDA because by doing so they agree to assume full regulatory responsibility for the pharmacies. In all likelihood, the FDA designed the MOU offer in a way that they knew would be rejected. In our opinion, the objective behind all of this is to shut down compounding simply because it threatens Big Pharma profits, and Big Pharma funds the FDA.
Sen. Vitter’s amendment addresses this issue by stipulating that, if a compounded medication is for an individual patient, there will be no cap on the amount that a pharmacy can ship interstate. It also stipulates that the MOU will not create unfunded regulatory burdens for states, which makes the prospect of entering into an MOU less onerous for states.
The amendment doesn’t fix all the issues that have arisen with new compounding regulations, but it takes a number of strong steps to address some of the worst problems. If passed, this amendment would go a long way in preserving consumer access to important compounded medications.
Action Alert! Write to your senators and urge them to support the Vitter amendment, which would take major steps to preserve consumer access to compounded medications. Please send your message immediately.