Senate Bill S. 959 was scheduled for a vote in the Senate as early as September. This bill, the Pharmaceutical Quality Security and Accountability Act, has implications that could negatively affect the access of doctors and patients to compounded prescriptions. If you are a doctor or patient who uses compounded medications, please act now to educate yourself on this bill and to contact your state's congressional representatives.
Although S. 959 was originally intended to prevent another tragedy like the 2012 meningitis outbreak linked to products compounded by the New England Compounding Center (NECC), the bill's current form creates broad intrusions into the practice of medicine and the relationship between doctor, pharmacist, and patient, while negatively affecting patient care. NECC was in violation of current laws, and had been cited previously for violations by FDA.
If passed as it is currently written, this bill will:
- decrease doctors' and patients' access to compounded prescriptions;
- increase the severity of national drug shortages;
- ignificantly increase the cost of compounded prescriptions for patients with established therapies;
- eliminate medication options currently available for doctors to address patients with special needs (allergies to ingredients in commercially available products, inability to swallow pills, metabolic irregularities, and other individual concerns);
- place arbitrary restrictions on choice of drug therapy based on generalizations instead of unique, individual considerations as determined by a patient and his/her doctor;
- interfere with doctors' practice of medicine by substituting the FDA's judgment for that of the physician who is familiar with the needs of his/her patient, and placing undue burden on the doctor to prove "clinical difference" between a compound and a commercially available alternative before being allowed to prescribe the necessary drug;
- penalize doctors and patients who currently choose an out-of-state pharmacy to provide their compounds by interfering with their established relationship to their pharmacist;
- create logistical difficulties for doctors by limiting the dispensing of office use medication to no more than 10% of total compounded medications that are dispensed within a 30-day period, and increasing clerical requirements for doctors using compounds.
The goal of improving the quality and safety of compounded medications must be balanced with efforts to preserve doctors' and patients' access to these medications, which can save lives, and on which many people already rely for personalized solutions which improve the quality of their lives.
The failures of this bill to balance those objectives are too many and too complex to fully address here, but some of the more problematic provisions are summarized below. More information can be found at protectmycompounds.com, mymedsmatter.com, and anh-usa.org.
S959 proposes a new category, "compounding manufacturer," for any entity that (A) compounds sterile medications, (B) ships across state lines, and (C) begins compounding before the receipt of a prescription (a practice necessary for safety and quality assurance, since sterile compounds must be quarantined for up to 18 days while being tested before they are dispensed). The new "compounding manufacturers" would no longer be licensed as pharmacies and by law could not fill prescriptions.
Current law requires that any pharmacy shipping medications to another state must be licensed in both the state where the prescription is made and the state to which it is shipped. If the medication is a sterile product, the pharmacy abides by USP<797> standards, which ensure proper sterile processes during its preparation. Since the 2012 meningitis outbreak was found to be a result of improper sterile procedures at NECC, a violation of regulations for which the FDA had cited this facility on multiple occasions since 2002, it is a fallacy that increasing the role of the FDA is an appropriate response to the tragedy that followed. Also, hospital systems would be exempt from the regulations, although an OIG Report (oig.hhs.gov/oe) found that 43.8% of hospitals surveyed do not have a USP<797> compliant clean room, yet they are responsible for medications used in vulnerable patient populations.
Compounding pharmacies that currently serve needs for sterile preparations in multiple states (a common situation due to the specialization and extensive investment in appropriate equipment and staff training required in this industry) will be forced to either give up the sterile compounds for their out-of-state patients, or sacrifice their valuable role as a pharmacy in the patient's established health-care relationship. In either scenario, patient care suffers as a result of an unnecessary rule prohibiting the use of a pharmacy in another state (even if the patient and doctor prefer that pharmacy because of its expertise with a medication or delivery format, an established relationship with the patient and doctor, better pricing than nearer competitors, or any other factors that the involved parties consider a priority).
The proposed legislation also gives FDA the authority to create a list of products that cannot be compounded based on an arbitrary designation that they are "difficult to compound." Sustained-release formulas, for example, would likely no longer be available for compounding, despite the fact that certain facilities have invested in equipment and techniques which have achieved success with many patients who would be left without their medication. Also at risk are preparations without an applicable USP or National Formulary (NF) monograph, which may currently be vital to patients using them. In addition, FDA is given expansive authority to discontinue medications that are currently effective by finding them to either fit an expanded definition of a "copy" of an FDA-approved drug or "for public health concerns," which could render compounded bioidentical hormone therapies unavailable.
The proposed legislation contains impractical provisions that limit volume of "office use" supply for health-care professionals in practice. The perception that volume is a determinant of risk when compounding medications is misleading in that USP<797> contains regulations and processes that ensure product quality and safety standards. Volume is not an accurate predictor of risk if proper sterile techniques are executed in the preparation of compounded medications.
FDA's appropriate regulatory role should remain where it has always been – the regulation of drug manufacturers, not pharmacies. All pharmacies are regulated by their state boards of pharmacy, and FDA already has criteria to determine when a compounder is illegally acting as a manufacturer. All pharmacies participating in sterile compounding should meet the standards set forth by USP<797> and state boards of pharmacy. The FDA should communicate with the state boards when a pharmacy is found violating its regulations, to ensure adequate quality and safety as well as optimal accessibility of all available medications. Since patient care is the main priority, proper regulation through state boards of pharmacy is necessary. The problem with the proposed legislation is that it falls short of increasing patient safety, while unduly limiting the access of patients and physicians to necessary and potentially lifesaving specialized medications.
Rod Harbin Jr.