It was likely to happen again somewhere … and it has. An investigative report late last month from BuzzFeed News uncovered allegations against a pharmaceutical “compounding” firm of severely harming the eyesight of at least 43 patients who used a formulated version of an injection meant to provide easier post-operative care for cataract surgery. The company is being accused in civil suits of failing to properly oversee the manufacturing of its product, which in later tests allegedly did not contain the same proportion of ingredients as the original manufacturer’s drug.
As NTU has pointed out in the past, community-based compounding pharmacies play a valuable role in the health care system by providing formulas of medications for individuals (e.g., liquefying a product for a patient who can’t swallow pills). In recent years, however, much larger compounding firms have been operating on an interstate basis, sometimes with tragic results when a medication’s quality is endangered or a formula is adulterated.
Taxpayers have a direct stake in how these businesses operate. The Department of Defense, for example, had to establish sensible payment and prescription guidelines when it was determined that monthly expenditures on compounded drugs had risen from $23 million to $550 million between 2010 and 2015. In Medicare Part D, compounded drug expenditures rose four times faster than overall program spending between 2006 and 2015. Medicare’s Inspector General suspects that some of this cost growth may be in medically questionable or even fraudulent transactions.
At the same time, the Food and Drug Administration as well as the Justice Department have been conducting hundreds of recalls, plant inspections, and enforcement actions, often with alarming findings for fiscal as well as medical reasons.
Equally worrisome, if compounded drugs are later found to have caused harm to patients, follow-on treatments can become the responsibility of taxpayers, through Medicare, Medicaid, and health insurance programs for veterans or government employees.
Overregulation is not the answer here; instead, sensible rules that protect taxpayers and patients while respecting the work of compounders are in order. States can more effectively police smaller pharmacies that produce limited quantities of medications than the federal government possibly can. Meanwhile, larger concerns that do business across state lines can be more effectively overseen by carefully-crafted regulations smartly administered by federal authorities. In all cases, public officials must take care to ensure that the economic, fiscal, and public health benefits of their actions outweigh the costs of the regulatory burdens they impose.
Scott Gottlieb, who heads FDA, has so far taken a fair and reasonable approach to addressing concerns with compounding. The FDA has issued guidelines that encourage states to take the lead in ensuring sound regulation on community-based pharmacies while Washington tackles the interstate piece of the puzzle.
Coordinating these activities with a minimum of bureaucracy isn’t easy, but the process continues to evolve: last week, federal and state agencies held an intergovernmental meeting to identify ongoing issues in FDA’s 2018 Compounding Policy Priorities Plan. The most recent tragedy over post-cataract surgery care is just one reminder that such meetings – and their takeaways for regulators – are of great importance and urgency.