Federal, state officials widen meningitis probes

Lawmakers and state authorities have expanded their investigations in the multistate meningitis outbreak to other compounding pharmacies and the industry's trade group.

Members of the House Energy and Commerce Committee requested information from the International Academy of Compounding Pharmacists (PDF) about communication the trade group provided to compounding pharmacies that were dealing with federal and state authorities.

“Allegations that your association may have encouraged compounding pharmacists to attempt to impede the FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns about your actions,” the lawmakers said in the Dec. 7 letter.

In a statement, the group said it would cooperate with the committee's request.

The meningitis outbreak was caused by tainted steroid injections distributed by the New England Compounding Center, a Framingham, Mass.-based compounder. NECC and Ameridose, a drug compounder that shared ownership with NECC, have since been shuttered in the wake of ongoing investigations.

As of Dec. 3, there have been 36 deaths and 533 infections as a result of the tainted vials of preservative-free methylprednisolone acetate, according to the Centers for Disease Control and Prevention.

Also last week, the Massachusetts Department of Public Health said it had issued cease and desist orders to three other compounding pharmacies in the state after conducting unannounced inspections that turned up safety concerns.

The compounders are OncoMed Pharmaceuticals in Waltham, Pallimed Solutions Pharmacy in Woburn and The Whittier Pharmacists in Haverhill.

The state said it has conducted surprise inspections of more than 12 compounders that produce sterile injectable medications following Massachusetts Gov. Deval Patrick's calls for unannounced inspections and new regulations for compounding pharmacies.

In addition, the public health department last week named three new members of the state's board of pharmacy, which came under scrutiny for its oversight of NECC and Ameridose.

“These respected healthcare professionals will use their experience to bring change to the board of pharmacy to enhance our oversight of this industry,” Dr. Lauren Smith, interim commission of the Department of Public Health, said in a news release.

The new board members are Patrick Gannon, vice president and chief quality officer for Southcoast Health System in New Bedford; Jane Franke, senior director of performance improvement innovations at Blue Cross and Blue Shield of Massachusetts; and Edmund Taglieri Jr., executive director of the Beaumont Rehabilitation and Skilled Nursing Center.