WASHINGTON Nov 14 The widow of a Kentucky judge who was among the first to die in a meningitis outbreak that has killed 32 people in 19 states asked Congress on Wednesday to crack down on drug compounders to prevent more needless tragedy.
"I would ask that you inquire how such a product became so widely distributed. Why did so many medical providers purchase this product from unregulated or poorly regulate sources?" Joyce Lovelace asked in written testimony to an oversight panel in the House of Representatives.
"Don't just investigate. Instead, legislate and regulate," she told the House Energy and Commerce subcommittee for oversight and investigations. "Plug the loopholes that allow these industries to escape meaningful inspection."
Lovelace is the widow of 78-year-old Eddie Lovelace, a state circuit judge who checked into Vanderbilt University Medical Center in September with symptoms that suggested he had suffered a mild stroke.
But within a week, his health began to deteriorate and he died on Sept. 17. Health officials later discovered he had contracted fungal meningitis after receiving epidural steroid injections produced by Framingham, Massachusetts-based New England Compounding Center.
"We now know that New England Compounding (Center) killed Eddie. I have lost my soul mate and life's partner with whom I worked side by side, day after day, for more than 50 years," Lovelace said in the document posted to the House committee's website.
The panel, scheduled to begin a hearing on the meningitis outbreak at 10 a.m. EST (1500 GMT), will seek to learn why regulators took no action against NECC despite repeated problems dating back to 1999, including adverse patient reactions to a sterile steroid treatment from as early as 2002.
Lovelace joins the U.S. Food and Drug Administration and the chief state public health officer of Massachusetts in calling on Congress to strengthen federal authority over drug compounders that are not currently subject to the stringent FDA safety and efficacy standards imposed on drug manufacturers.
A handful of Democratic lawmakers have pledged to introduce legislation to shore up FDA's oversight powers over compounders, which have been challenged successfully by pharmacies in federal court and targeted by industry lobbyists in Congress.
Drug compounding is a little-known practice in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients. It is overseen mainly by state authorities that are often ill-equipped for the job.
The activity has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.
"At times, our depression is temporarily replaced with anger. At other times, it is replaced by determination and resolve," Lovelace said in her testimony.
In the case of NECC, FDA and state health officials carried out inspections in 2002 and 2003 before deciding that the company's operations did not constitute a manufacturing operation that would have merited FDA scrutiny.
That left the regulatory responsibility to the Massachusetts Board of Registration in Pharmacy, which failed to carry out sanctions against NECC despite repeated problems that culminated this year's outbreak.