Monday, September 23, 2013

Hune's bill right; Congress needs to act

Livingston County’s state Sen. Joe Hune announced last week he will soon be introducing legislation to tighten regulations on compounding pharmacies.

Working with Bill Schuette, Michigan’s attorney general, and Steve Arwood, director of the state Department of Licensing and Regulatory Affairs, the Republican from Hamburg Township said he’d propose new rules including that each compounding pharmacy would be required to have a “pharmacist in charge,” accountable for all activity at the site; improve recordkeeping; and submit to state inspections at least once every two years.

Good proposals. But there is a problem. This bill would not have prevented the fungal meningitis outbreak linked to tainted steroids that resulted in eight deaths right here in Livingston County.
Those steroids were mixed at a compounding pharmacy in Massachusetts, under Massachusetts regulations, with Massachusetts oversight ... or lacking it.

And under interstate commerce rules, Michigan can’t block the import of drugs and medicines compounded in other states ... even if it thinks their state rules for compounding are lax.

This is exactly why we argued on this page last week that it is Congress’ responsibility to clarify the regulations for these types of facilities. In the year since the outbreak began, Congress has pointed the finger at the federal Food and Drug Administration, which argued back that Congress took away its authority to regulate these facilities. In the meantime, precious little action has been taken to avoid a repeat of a problem that sickened 750 people nationwide, resulting in 64 deaths.

None of this should be taken as a criticism of Hune’s proposal. Hune, Schuette and Arwood are doing exactly what they should be doing given the situation — insuring that the products turned out by compounding pharmacies in Michigan are safe.

In fact, since Congress has not acted, it is up to state lawmakers in every one of the 50 states to assure that their compounding pharmacies are safe. The follow-up question of course is whether it is really reasonable to expect 50 state legislatures to act. Would all 50 states enact equally valid regulations?

It is important to understand what compounding is. Drugmakers produce medicines, and that process is overseen and inspected by the FDA. Compounding is mixing, either mixing different drugs
together or mixing drugs with other ingredients, like combining cough syrup with cherry flavoring.
Mixing is considered a pharmacy function, and so regulation is left to state boards of pharmacy. Still, as we saw in the case of the New England Compounding Center’s production of tainted steroids, the potential for contamination is there and the products are shipped across the country.

It is disappointing that no member of Michigan’s congressional delegation has stepped forward to introduce a bill with new regulations, or to clarify the existing ones.

Michigan was particularly hard hit by fungal meningitis. No other state had as many cases. Here, 264 fell sick after receiving the contaminated shots. Nineteen died.

So while we say “good job” to Hune, Schuette and Arwood, we can only hope that Michigan’s federal lawmakers will follow suit.

And we’d especially encourage Livingston County’s lawmakers in Washington — Republican Mike Rogers and Democrats Carl Levin and Debbie Stabenow — to make this a personal cause.

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