Tuesday, January 7, 2014

Compounding pharmacy bill negotiators haven't met

STATE HOUSE, BOSTON - Appointed in early November, the conference committee charged with finalizing a bill to tune up the state’s regulation of compounding pharmacies will meet for the first time this week.

“We’re meeting soon,” said Rep. Jeffrey Sanchez, a Jamaica Plain Democrat and House chairman of the Committee on Public Health who drafted the House bill.

The House passed its compounding pharmacy bill Oct. 2, 2013 on a vote of 157-0. On Oct. 30, 2013 the Senate voted 38-0 for its bill. The negotiating team was named Nov. 7, or about two months ago.

Four major bills, including the pharmacy regulation legislation, passed the House and Senate in differing forms last year but have failed to emerge from six-member conference committees.

A fungus in purportedly sterile steroid injections made by the New England Compounding Center caused a fungal meningitis outbreak in the fall of 2012.

The tainted drugs have killed 64, with deaths mostly in Michigan, Tennessee and Indiana, according to the Centers for Disease Control and Prevention.

Among the 751 sickened by the contaminated drug were 14 people in New Hampshire and three in Rhode Island, though none in Massachusetts where NECC was allegedly producing greater quantities of drugs than it was licensed to make.

Compounded medications generally cater to a particular patient, who might have an allergy to a common drug ingredient or need different dosages than is available through manufactured drugs.

In the state legislative and congressional hearings that followed the outbreak, blame for insufficient oversight shifted between the Food and Drug Administration, which regulates manufactured drugs, and the state Board of Registration in Pharmacy, which regulates compounding pharmacies.

The public health crisis motivated Gov. Deval Patrick to make changes at the Board of Registration in Pharmacy and the Department of Public Health stepped up inspections of the pharmacies that are permitted to create custom mixes of drugs.

Federal legislation reached the desk of President Barack Obama and became law on Nov. 27.

“Americans going to their doctor’s office or pharmacy will now have the confidence that their drugs are safe,” Congressman Fred Upton, a Republican from southwestern Michigan, said in a statement, which also noted three deaths occurred in his district.

According to the White House, the federal law “clarifies” the FDA’s authority to regulate compounded drugs, gives the FDA authority to develop a “track-and-trace system to secure the pharmaceutical supply chain,” and creates “a new voluntary program for FDA to regulate entities engaged in batch compounding that elect to register” with the FDA.

The state bills (H 3672/ S 1899) would essentially set into law new inspection procedures, overhaul the licensing of sterile compounding pharmacies and reconfigure the pharmacy board.

The House version calls for an 11-member Board of Registration in Pharmacy, while the Senate version calls for a 13-member board. Both would be made up of mostly pharmacists and include one pharmacy technician, one member of the public with certain qualifications, one doctor, one nurse and one patient safety expert. Current state law provides for an 11-member board with five pharmacists.

The first conference committee will be held at 2 p.m. on Wednesday, according to a legislative aide.

The conferees are Sen. John Keenan, Sen. Stephen Brewer, Sen. Bruce Tarr, Rep. Brian Dempsey, Rep. David Vieira, and Sanchez.

“I feel hopeful,” said Sanchez. He said, “I have a great working relationship with Senator Keenan.”

Sanchez said schedules around the holidays made it difficult for negotiators to come together earlier.

Lawmakers are also seeking to reconcile two versions of a bill to provide aid to veterans, legislation dealing with welfare reform, and bills aimed at reducing and preventing mercury pollution.

Veterans and Federal Affairs House Chairman Carlo Basile said the conference committee on the veterans bills has met twice and is planning another meeting.

“Things are headed in the right direction,” said Basile.


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