Monday, September 16, 2013

Pharmacy fight looms in wake of meningitis outbreak

WASHINGTON — A U.S. House bill introduced after a meningitis outbreak tied to tainted drugs that killed 19 Michiganders and affected hundreds of others seeks to clarify federal authority over certain pharmaceutical providers.

But the measure stops short of expanding that authority as far as a proposal in the Senate.

The legislation — introduced by U.S. Reps. Morgan Griffith, R-Va., Gene Green, D-Texas, and Diana DeGette, D-Colo. — sets up a potential battle over the scope of authority the Food and Drug Administration would have to regulate so-called compounding pharmacies, one of which was the cause of the outbreak.

House sponsors balked at giving additional authority to the FDA under the bill, arguing — as members did in oversight hearings with federal authorities — that the agency failed to use its existing powers in reacting to concerns at the New England Compounding Center in Masssachusetts before the outbreak last fall.

“My position on that has always been that the FDA had the authority,” Griffith said. “FDA should have known. ... The warning signals were all out there.”

No state has been more affected by the meningitis outbreak that began last September than Michigan. The Centers for Disease Control and Prevention tracked 264 cases in the state. Nationally, there were 750 cases and 64 deaths in 20 states linked to fungal contamination of injectable steroids supplied by the NECC.

After the outbreak, the FDA stepped up enforcement actions against compounding pharmacies, a term traditionally applied to businesses that mix drugs for specific needs of a patient. More recently, it’s been applied to larger producers supplying compounds to hospitals and other health-care practitioners that once made them in-house.

By compounding drugs, pharmacists can tailor-make medicines that, for instance, leave out an agent that a patient may be allergic to, or convert a drug into a liquid for a patient who can’t swallow pills.

But there’s been confusion over who has oversight for compounding pharmacies: Once they can be defined as manufacturers, the FDA has authority; but, typically, state boards maintained control over more traditional compounding pharmacies.

The FDA said it has had to contend with conflicting court opinions over the issue of authority, along with legal foot-dragging by compounding pharmacies that was aimed at blocking its oversight. In congressional testimony in April, FDA Commssioner Margaret Hamburg said there could be “hundreds of other firms operating as compounding pharmacies” producing sterile products and shipping them across state lines outside the agency’s knowledge.

“The current legal framework does not provide FDA with the tools needed to identify and adequately regulate these pharmacies to prevent contamination,” she said.

Plus, there has been wide disagreement over what Congress should do to correct that.

In June, a group including former Health and Human Services Secretary Tommy Thompson was created to push for stronger regulations on the manufacturing of medications “under the guise of pharmacy compounding outside of FDA oversight.” But other groups, like the trade group International Academy of Compounding Pharmacists, have argued that while changes are needed, federal authority over traditional compounders should not usurp state laws.

The Senate bill would create a new class of drug manufacturers — the House bill calls them “outsourcers” — but it would put in place a list of drugs that could not be compounded, and set deadlines for compounding pharmacies to receive the names of patients receiving their drugs.

“We need to ensure that tragedies like NECC never happen again,” said David Miller, executive vice president and CEO of the compounding pharmacists group.

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