Rep. Markey (D-MA) has studied the problem carefully (NECC is in his district) and has filed a thoughtful bill in Congress today (one pager here; section summary here; full text here). Simple compounding is left to state regulation; sterile compounding and commercial scale operations get stricter federal oversight. It’s a good bill, but I have some comments:
- The transparency provisions should be stronger: inspection reports should be published, like restaurant inspections.
- The bill requires warnings on the label, but that won’t directly impact patients since they never see the labels for sterile injectable drugs. I suggest making patient disclosure a condition for billing the drug.
- Instead of “one-size-fits-all” regulation, the bill allows states with demonstrated regulatory capacity to share regulatory responsibility.
- The bill also avoids constitutional pitfalls, which doomed the last attempt to regulate this industry.
On the state level, the Massachusetts Joint Committee on Public Health should release their bill soon. It is expected to also propose an enhanced “intermediate” level of regulation for the higher risk forms of compounding. If the federal bill becomes law, some adjustments will have to be made at the state level, but Massachusetts shouldn’t wait for the feds. (Congress has many issues to face). The most prominent example is the state regulation of out-of-state compounders. This is inefficient, but necessary, at least until we have a real federal law.
Both bills avoided the temptation to over-regulate the traditional practice of compounding.
@koutterson
Note: I’ve talked with many government officials and others after the NECC crisis about compounding, but always pro bono.
