Patrick Proposes Changes To Improve Pharmacy Oversight
Finding the state’s current regulatory system insufficient to handle the compounding pharmacy industry, Gov. Deval Patrick is filing legislation to strengthen controls and state health officials are planning to make their own improvements.
With confusion over whether the state’s Board of Registration in Pharmacy or the federal Food and Drug Administration was responsible, government regulators failed to prevent the New England Compounding Center from improperly manufacturing batches of tainted steroids that have killed at least 39 people and sickened 656 more beginning last fall.
“The tragic meningitis outbreak has shown us all that the board’s governing authority has not kept up with an industry that has evolved from corner drugstores to the types of large manufacturers that have been at the center of so much harm,” Patrick said.
He said his bill would change the makeup and the role of the pharmacy board. The bill would add more people from outside the compounding industry; it would create a special license for sterile compounding; it would for the first time institute monetary fines for compounding companies that violate regulations; it would provide protections for whistleblowers; and it would require licenses for out-of-state pharmacies operating in Massachusetts.
The legislation was based on recommendations from the Special Commission on the Oversight of Compounding Pharmacies, led by Christian Hartman, and several of the recommendations require no change in law or regulation.
The commission recommended that the new law should “establish whistleblower rewards similar to the False Claims Act.”
The commission said the pharmacy board should make its meeting minutes and board members’ information publicly available on the website, promote interdisciplinary relationships and increase inspections, which should be accompanied by the posting of inspection results within 30 days of the action. The commission also recommended that the state establish “a formal communication mechanism” with the FDA.
Patrick said he diverged from the commission’s recommendations in terms of the makeup of the pharmacy board, saying the legislation would include “more breadth of professional experience.” According to the Patrick administration, the bill will call for an 11-member board of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three public members. Current law governing the board’s makeup calls for two members of the public on the board.
Patrick also said he supports Attorney General Martha Coakley’s bill that would raise the fine for corporate manslaughter from $1,000 to $250,000.
“This is a long-overdue deterrent,” Patrick said. He said, “Today’s announcement is one of several reform proposals that we will be filing over the next week to address several different needs.”
A proponent of stronger federal regulations, U.S. Rep. Ed Markey also praised the proposal, saying it will “ensure that Massachusetts has the strongest state pharmacy regulations on the books, helping prevent another drug compounding disaster from happening in Massachusetts again.”
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