First there was the deadly outbreak of meningitis last year, and another rash of infections (here and here ) within a couple of months earlier this year, and Congress continues to talk seriously about better oversight of the compounding pharmacies that make potentially dangerous drugs.
Talk, yes; do … not so much.
Federal legislators, as reported by MedPageToday.com, are grappling with where to draw the line between state and federal control of compounding pharmacies. These facilities were meant to address a specific need, such as making customized drugs to order for local patients when other meds are not available commercially or are delivered in a way the patient can’t tolerate. But some compounding pharmacies have become so big and generalized that they’re essentially like other pharmaceutical manufacturers, only without rigorous regulation.
Some lawmakers are concerned that not allowing a limited number of “office stock” or advance prescriptions from compounders that aren’t subject to FDA oversight might impede immediate access to certain drugs for people who desperately need them.
It’s pretty much accepted now that the FDA should exercise more authority over compounding pharmacies, but last week, reports MedPage Today, congressional representatives seemed unwilling to tighten the regulations. Although they don’t want to ignore or be perceived as enabling lax oversight of large-scale compounding pharmacies such as the New England Compound Center (NECC) that was responsible for the meningitis outbreak that killed scores and sickened hundreds, they also acknowledged that those manufacturers are important for people who don’t respond to or can’t tolerate mass-produced brand-name and generic meds.
One congressman is drafting legislation to put some compounding pharmacies under the FDA’s purview, superseding state oversight if their volume passed a certain point, for example. The law also would subject compounding pharmacies that ship drugs across state lines to FDA oversight and limit their commerce.
But the FDA’s director of the Center for Drug Evaluation and Research said volume alone is a tricky factor for judging risk. A compounder, like the NECC, might ship several small batches to hundreds of providers and suddenly qualify as a large-scale manufacturer.
A Senate bill approved in May by the Health, Education, Labor and Pensions Committee would make pharmacies that produce sterile drugs without a prescription and ship them across state lines subject to FDA authority.
Of course, the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), claims that these measures would create confusion between traditional pharmacies and large-scale compounders and between compounders and traditional manufacturers.
The consumer organization Public Citizen’s Health Research Group is critical, says MedPage Today, of both versions of the legislation. It echoes PhRMA’s concerns that the Senate bill would create a “second, substandard tier of drug manufacturers, confusingly called ‘compounding manufacturers'”; such facilities would not be required to get new drug approval by the FDA or comply with the standard federal labeling requirements.
Public Citizen also says that neither bill requires compounding pharmacies that mass-produce standardized drugs to get pre-market approval from the FDA or meet federal labeling requirements.
House Republicans aren’t eager to create a new class of compounding manufacturers separate from traditional manufacturers and traditional compounders. They say the FDA has all the power it needs to prevent the spread of disease caused by contaminated compounds.
It is difficult in some cases to balance patient need with safety. But when you’ve had at least three major outbreaks within a year, something isn’t working. The situation is intolerable.