Facing some measure of accountability for the 32 people who have died and more than 460 who have been sickened, the owner of the New England Compounding Center raised his right hand before the House of Representatives, swore to tell the truth and then refused to answer any questions.
Our Boston meningitis attorneys are not surprised that the head of a company that has shown so little regard for the well-being of others would fail to take responsibility and provide answers to the families who have lost loved ones.
He will be called again to testify soon before a Senate committee, though it’s likely we can expect more of the same.
Perhaps even more troubling is that while Congress presses forward with efforts to obtain some insight, legislators had the opportunity nearly a decade ago to approve measures that might have prevented this in the first place – and shut down this dangerous operation.
Back in 2003, Dr. Steven Galson was a top official at the U.S. Food and Drug Administration. At the time, he testified before the Senate Health, Education, Labor and Pensions Committee, telling them that his agency had conducted a small survey on about a dozen compounding pharmacies.
If you recall, these are facilities where the intent is to make custom drugs at the request of physicians for certain patients. Instead, what we are finding is that they have been mass-producing medication without a license, which is partly what officials believe led to the contamination issues that spurred the nationwide fungal meningitis outbreak.
Galson at the time told the committee that of the 29 drugs tested, including steroids, hormones, antibiotics and drugs to treat asthma, erectile dysfunction and glaucoma, 10 failed quality testing. Nine of those failed potency tests, in some cases showing a potency of less than 70 percent.
When people are counting on these drugs to aid them in meeting critical medical needs, this is absolutely unacceptable.
Now compare those results to the tests conducted around the same time on products directly from drug manufacturers. Of 3,000 samples tested, only four failed quality control.
FDA officials say the government had ample warning of serious problems in the compounding industry, and yet chose not to act.
Shortly after Galson delivered his testimony, Congress shot down an effort to establish an FDA oversight committee specifically for compounding pharmacies. And there have been multiple efforts since then to establish a greater level of oversight – and legislators have continued to shoot them down. Before his death, Massachusetts Senator Ted Kennedy sponsored a bill that would have created better oversight, however lawmakers failed to pass it amid heavy lobbying by the pharmaceutical industry.
Lobbyists continue to stress the great need for compounding facilities. We could concede that, when operated as intended and according to the high standards set for other drug makers, these facilities serve a purpose. However, the problems began when Congress repeatedly denied oversight authority to the FDA.
Now, legislators are demanding answers from the NECC (and the Ameridose facility, also in Massachusetts). But the fact is, these problems were nothing new. Too bad that it took a tragedy of this scale for Congress to take action.
If you are have been affected by the fungal meningitis outbreak, call the Massachusetts Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Insight: How compounding pharmacies rallied patients to fight regulation, Oct. 16, 2012, By Sharon Begley, Reuters
More Blog Entries:
Another Massachusetts Pharmacy Under Fire: Ameridose Injections Contaminated, Nov. 13, 2012, Boston Personal Injury Lawyer