Last December, the Justice Department announced the indictiment of the owner/head pharmacist, the supervising pharmacist, and 12 others associated with the New England Compounding Compounding Center. The 131-count indictment, which included 25 charges of second-degree murder, grew out of a 2012 outbreak of fungal meningitis caused by contaminated drugs manufactured by the company. More than 750 patients were diagnosed with the illness as a result, and 64 patients in nine states died from it. 
In a February 28, 2015, op-ed in USA Today, CPR President Rena Steinzor, author of Why Not Jail? Industrial Catastrophes, Corporate Malfeasance, and Government Inaction, recounts the story and then takes a look at how policymakers reacted, and what came of their response. The tragedy laid bare a gaping hole in the nation's regulatory fabric, and rather than addressing it with straightforward legislation and resources to enforce it, Congress pass a "market-based" bill that allowed individual compounding pharmacies to decide for themselves if they'd like to be regulated or not. She writes:
In March 2013, Congress passed bipartisan legislation to fix the problem. Incredibly, though, it allowed compounding pharmacists to decide whether to volunteer to be regulated. Unless they register with the FDA, the agency has no way of knowing about them except through patient and medical professional complaints, a reporting method that in many cases comes far too late. The rationale? Market forces will take care of the problem because no hospital or treatment center will want to deal with an unregistered company.
In January, the Office of the Inspector General at the Department of Health and Human Services issued a report regarding Medicare's oversight of compounding pharmacies that supply hospitals. Contrary to the optimism of Congress, the report found that as of January 1, 2015, just 26 compounding pharmacies had registered with the FDA. According to the industry's main trade association, 7,500 community-based pharmacies operate around the country, and 3,000 of that number make sterile preparations. The Inspector General also found that Medicare auditors did barely anything to review how hospitals choose and scrutinize manufacturers of compounded sterile preparations, again because of resource shortfalls and lack of training. So much for Congress's half-baked fix for the problem.
Showing 2,880 results
Matthew Freeman | March 1, 2015
Last December, the Justice Department announced the indictiment of the owner/head pharmacist, the supervising pharmacist, and 12 others associated with the New England Compounding Compounding Center. The 131-count indictment, which included 25 charges of second-degree murder, grew out of a 2012 outbreak of fungal meningitis caused by contaminated drugs manufactured by the company. More than […]
James Goodwin | February 27, 2015
In keeping with an apparent effort to hold an antiregulatory hearing on any and all days ending in “y,” Congressional Republicans have teed up yet another humdinger for Monday, March 2. That’s when the House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Administrative law will take a closer look at three more antiregulatory bills […]
Matt Shudtz | February 24, 2015
This week, the Maryland General Assembly will review new legislation that could help ensure safer workplaces in the state’s construction industry. The proposal, which is a type of “responsible contracting” legislation similar to other policies being tested out in states and municipalities across the country, would require companies that put in bids for work on […]
James Goodwin | February 24, 2015
A clock hangs in Room 342 of the Dirksen Senate Office Building—the room where tomorrow at 10:00 am the Republican leadership of the Senate Homeland Security and Government Affairs Committee will convene its first antiregulatory circus hearing of the new Congress. Below that clock, the hearing will play out according to a now-familiar script: the […]
Victor Flatt | February 23, 2015
Today I joined a group more than 40 environmental law professors and clinicians from institutions around the nation in a joint letter to the University of North Carolina System Board of Governors urging that they reject a recommendation to shutter the Center on Poverty, Work and Opportunity, housed at the University of North Carolina Law […]
Matt Shudtz | February 19, 2015
Our intrepid colleague Celeste Monforton, who writes at the Pump Handle blog, recently passed along a neat example of a tool that we wrote about in our Winning Safer Workplaces manual. Minnesota’s Office of the Legislative Auditor released a report on the state’s regulatory protections for meatpacking workers. As we noted in the Winning Safer […]
James Goodwin | February 17, 2015
Last week, Rep. Doug Collins (R-Ga.) and Sen. Chuck Grassley (R-Iowa) continued the parade of anti-regulatory bills resurrected from past sessions of Congress by introducing in their respective chambers the Sunshine for Regulatory Decrees and Settlements Act of 2015 (SRDSA). While all of these anti-regulatory bills are categorically terrible, the SRDSA really needs to be […]
James Goodwin | February 13, 2015
At last, the Obama Administration is articulating a sense of urgency about moving vitally needed health and safty regulations through its pipeline. Here’s Howard Shelanski, White House Office of Information and Regulatory Affairs, in a Bloomberg BNA story this week: “So we are working now, here in January of 2015, on getting priorities lined up, […]
Rena Steinzor | February 11, 2015
Today, the Government Accountability Office (GAO) reiterated its conclusion that EPA’s regulation of toxic chemicals is in crisis, unable to deliver badly needed protection to the American people. These benighted programs are among a couple of dozen of “high priority” failures that cause serious harm to public health, waste resources, or endanger national security, and […]