By Scott Gottlieb, M.D.
The tragic deaths of 55 Americans and sickening of more than 740, resulting from contaminated steroid injections that were shipped by a disreputable firm in Massachusetts, have focused public attention on a largely unfamiliar, but prominent part of our drug supply chain – the practice of pharmacy compounding. Observers are calling on Congress to give FDA more power over these firms.
New laws merit consideration, and yesterday I participated in a hearing before the House Energy and Commerce Committee, Subcommittee on Health, as legislators consider how to shore up supervision of the drugs produced by these pharmacies. My testimony is available online.
Applying more vigilant rules to the compounding pharmacies starts with articulating clear and bright lines between the legitimate practice of pharmacy compounding (which should be subject solely to state and professional regulation and not FDA) and then those firms operating illegally as large-scale drug manufacturers under the guise of a pharmacy license. These firms should be treated as new drug makers, and subject to FDA oversight.
To these ends, FDA’s message, and how the agency is framing the problem, does not adequately explain the scope of the risks and its solutions.
The compounding industry has evolved rapidly over the past decade – in some cases, as a result of FDA’s own decisions that have given greater incentives to compounding firms to get into new, and sometimes-illegal markets.
For example, in recent years FDA has sometimes ignored compounders who were making cheap, but illegal (and unapproved) copies of FDA approved products. The FDA’s political chiefs had a preference for the cheap, compounded drugs. FDA has also largely allowed compounders to plug drug shortages that were created by FDA’s abrupt changes in how the agency oversees the sterile manufacturing operations at legitimate generic drug makers.
Now, FDA’s posture is that the agency doesn’t have enough authority to adequately regulate the burgeoning compounding industry.
Whether the broader problem was in part of FDA’s own making is partly material here. It speaks to the need for FDA to apply even enforcement in the future – and not cutting illegal drug makers some slack because the end products are cheap and thus politically popular. This is going to be especially true if FDA creates a new class of regulation for the compounding firms. Uneven enforcement could give these outfits unfair advantage to obviate the intellectual property of legitimate drug makers.
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