Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is “anti-pharmacy” and is relying on a parliamentary maneuver that may stifle further debate.
Specifically, the NCPA objects to provisions that require individual pharmacies to report directly to the FDA when compounding a drug that is in short supply; allows the FDA to establish a ‘do not compound’ list and exempts hospital pharmacies from these requirements. The group also believes the bill does not adequately address physician office use of compounded medicines (here is the bill).
“We object strenuously and are working feverishly with House lawmakers to produce fair and balanced legislation that would enable community pharmacy compounding to continue to serve patients, not give the FDA unprecedented authority over the practice of pharmaceutical compounding and stop manufacturers from hiding behind a pharmacy license,” NCPA ceo Doug Hoey wrote in a July 26 e-mail to members.
The bill, known as the Pharmaceutical Compounding Quality and Accounting Act, emerged following the fungal meningitis outbreak last winter that was traced to the New England Compounding Center. The episode has led so far led to 749 cases, including 61 deaths, and has been described as the worst public health crisis in the US in decades (more here).
The ensuing controversy led to furious debate about the oversight role of the FDA, as well as state health officials, and the extent to which the tragedy could have been prevented. Although FDA officials acknowledged they could have taken enforcement steps sooner against NECC, the agency also lobbied Congress for a new law that would clarify its oversight powers and proposed creating two forms of compounding so that higher-risk production can be more closely regulated (back stories here and here).
Meanwhile, the NCPA, which represents independent pharmacies across the US, told its members that the issue is urgent, because the Senate is expected to take up the legislation this week, but will not require votes from individual senators, but will instead relay on unanimous consent. Unless any one senator objects to this procedure, a bill can pass (see this).
“Please call your senators and urge them to oppose unanimous consent for (the Pharmaceutical Compounding Quality and Accounting Act), because it expands federal oversight over small businesses and, therefore, deserves to be fully debated and open to amendment,” the e-mail continues, adding that the NCPA is working with House lawmaker, Morgan Griffith, a Republican from Virginia, on an alternative.
However, one consumer advocate believes the NCPA objections are misplaced. “The Senate has taken a bipartisan approach that leaves most pharmacy practice entirely untouched,” says Allan Coukell, director of the Pew Prescription Project. “Anyone fulfilling a prescription is untouched.
“Anybody can make sterile products without a prescription, but if they sell out of state, they would come under FDA jurisdiction… If you do those things, then you’d no longer be a pharmacy, but would be a compounding manufacturer and would have to meet a higher standard. This is hardly a big intrusion into traditional pharmacy practice.”
However, another consumer advocacy group has objected to the Senate bill. Public Citizen argues the legislation is deficient because it would not require compounding pharmacies that mass-produce standardized drugs to seek pre-market approval from the FDA or meet important federal labeling requirements. The advocacy groups criticizes a House bill and the Griffith draft over the same point.
The Senate bill would create a “second, substandard tier of drug manufacturers, confusingly called ‘compounding manufacturers,’” which would not be required to get new drug approval by the FDA or comply with the standard federal labeling requirements. “All drug manufacturers should be held to the same standards,” Public Citizen argues.
As for the Griffith draft, the group says this would allow drugs to enter the market with minimal standards of safety oversight, as does the Senate bill, would maintain an ‘advanced compounding’ provision that has been abused by compounders in the past. It also permits unlimited non-patient-specific purchasing by health care providers of compounded drugs to be administered in a health care setting – a category of drugs that already is high-risk, Public Citizen says in a statement.
As we reported previously, the American Academy of Ophthalmology lobbied in vain to have removed from the Senate bill a provision that requires patients to have specific prescriptions for each medicine that is ordered from a compounding pharmacy. They argued the language will have unintended consequences because the would preclude many patients from being able to afford compounded versions of Avastin, a biologic that is widely used for treating age-related wet macular degeneration (back story).
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