Why gov's pharmacy bill may not prevent another health crisis

BOSTON, Mass. (WWLP) — At the beginning of the year, Governor Deval Patrick proposed legislation that strengthens oversight over the compounding pharmacy industry.  But critics point out that money for additional pharmacy inspections will be hard to find. They further argue that there’s no way to regulate compounding pharmacies licensed out-of-state.

“There’s really at this point a patchwork between different states of different statutes and regulations governing compounding.  So to a certain extent individuals receiving compounding products from outside the state are not going to be protected by these new proposals,” said Mark Josephs, an attorney and partner at Edwards Wildman Palmer LLP.

Critics say there needs to be better federal jurisdiction and oversight over compounding pharmacies – especially following the deadly meningitis outbreak caused by tainted medications manufactured at the Framingham-based New England Compounding Center.  Late-U.S. Senator Ted Kennedy fought for many years for tougher regulations. 

“[Kennedy] was ultimately defeated by the lobbyists who brought a lot of pressure to bear,” said Sen. Elizabeth Warren (D-Massachusetts), who sits on the U.S. Senate Committee on Health, Education, Labor and Pensions.  “It’s clear that there are real costs when we don’t have adequate safety regulation in place so it’s something we will be working on and I’m looking forward to it.”

Governor Patrick’s legislation addresses part of the problem by requiring compounding pharmacies to report how much and where they ship medications.   In NECC’s case, it was unclear whether they were a local pharmacy under state jurisdiction, or a mass manufacturer under the strict authority of the U.S. Food and Drug Administration. That confusion led to inaction by both state and federal regulators.

40 people have died and more than 600 people have been sickened across the country because of the meningitis outbreak linked to NECC.

 

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