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
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.