Citizen Health & Safety
State Regulation of Compounding Pharmacies Is Inadequate
Over the past several weeks, 36 people have died and more than 500 others have been infected with fungal meningitis from tainted steroids obtained from a compounding pharmacy in Massachusetts. This industry prefers state regulation of its practices and has been fighting Food and Drug Administration (FDA) oversight for more than a decade. Some, including Rep. Ed Markey (D-MA) and FDA Commissioner Margaret Hamburg, are now calling for clear FDA oversight authority over compounding pharmacies.
Traditionally, compounding pharmacies mixed medicines specifically for individual patients, following the instructions in a health care provider's prescription. For example, they would eliminate an allergen from a medicine or put cherry flavoring in foul-tasting medicine based on an individual patient’s needs. States oversee these compounding practices. But 42 states permit a practice known as "compounding for office use" where a pharmacist prepares multiple doses of a medicine without a prescription for a specific patient and sells those doses to providers. At some point, a compounding pharmacy produces so many doses of a medicine that its practices begin to look like manufacturing rather than compounding.
Generally, states have regulated pharmacy practices, and the compounding industry prefers to leave it that way. Markey's recent report on the industry suggests the reason why. Only six states have a record of taking enforcement action against compounding pharmacies since 2001. As Markey's report notes, "State regulators are not, or cannot, perform the same sort of safety related oversight of compounding pharmacy practices that FDA has historically undertaken." In other words, effective FDA standards might have safeguarded the public from the meningitis outbreak.
FDA's authority to regulate the manufacture of drugs is clear. It must approve new drugs as "safe and effective" before they can be marketed, and it may seek a court order to shut down any drugmaking activity if substances are misbranded or adulterated. Before doing so, the FDA will usually send a warning letter to the manufacturer seeking voluntary compliance.
But FDA's authority over compounding pharmacies is unclear. The agency describes its authority as "more limited" compared with its authority over traditional drug manufacturers. As far back as 1996, then-FDA Commissioner David Kessler warned that unregulated compounding pharmacies could harm the public, and the agency has repeatedly urged Congress to give it clearer oversight authority.
Despite the ambiguity about its regulatory authority over compounding pharmacies, the FDA has issued 60 warning letters about unsafe compounded drugs since 2001. FDA takes this action when it believes compounding pharmacies are manufacturing misbranded or adulterated products. But because the compounding industry vigorously contests FDA’s authority over its practices in court, if the agency sought a court order to shut down these practices, it would need to invest significant resources (at the expense of other priorities). Given past court decisions, it might not be successful. Of course, these ambiguities were created by the compounding industry and allow it to profit with little effective oversight – at either the state or federal level.
The compounding industry has vigorously fought congressional efforts to increase federal regulation of its practices. At the behest of compounding pharmacies, courts struck down portions of legislation that would have increased FDA’s oversight role, and in 2007, industry lobbying helped defeat a bipartisan bill to grant FDA clear authority over compounding pharmacies. The latest meningitis outbreak ensures that legislators will revisit the issue in the 113th Congress.
Time after time, the story is the same: Industry opposes federal oversight of potentially dangerous practices and argues that state regulation is preferable. In fact, industry prefers state regulation because state standards are often weaker than federal standards, and/or enforcement at the state level is less effective.
A few states are known for rigorously protecting public health, but effective state standards, adequately enforced, are the exception, not the rule. Markey and others hope the current outbreak will spur Congress to finally take action to improve federal oversight of these facilities.
Image courtesy of the Centers for Disease Control and Prevention
Editor's Note: This article has been updated since its original publication date to update the number of fatalities and infections from the current fungal meningitis outbreak.