* Republicans give FDA until Nov. 30 to produce documents
* Democrats who joined earlier request not part of new call
By David Morgan
WASHINGTON, Nov 19 Republicans on a
congressional panel investigating a deadly meningitis outbreak
linked to tainted drugs have told the top U.S. drug regulator
not to expect new authority to prevent future problems until the
agency hands over documents about its role in the current
As the number of meningitis cases edged toward the 500-mark,
the House of Representatives Energy and Commerce Committee's
Republican majority staff released on Monday a letter that gave
the Food and Drug Administration until the end of November to
comply with a document request first made in mid-October.
"We need these documents to identify any possible weaknesses
in FDA's regulatory system that can be immediately corrected
administratively or legislatively," said the letter, dated Nov.
16 and addressed to FDA Commissioner Margaret Hamburg by four
Republicans, including committee chairman Fred Upton.
"This committee has a long history of thoroughly and
deliberatively investigating problems and offering solutions. We
cannot and will not be in a position to do so in this case until
we have a full accounting," the letter said.
FDA officials had no immediate comment.
The regulatory agency has asked lawmakers to clarify its
authority to oversee large-scale drug compounders like
Massachusetts-based New England Compounding Center, the maker of
epidural steroid injections that have been linked to a fungal
meningitis outbreak that has now killed 33 people in 19 states.
Drug compounding is a longstanding practice in which
pharmacists alter or recombine existing drugs to meet the
special needs of specific patients. Some compounders have
evolved into large-scale producers that experts say should be
subject to FDA regulation.
State pharmacy boards are primarily responsible for
oversight at the moment. FDA officials say their authority to
oversee compounders has been challenged regularly in federal
court, leading to conflicting rulings in different parts of the
A handful of House Democrats have called for congressional
action to bring clarity to the situation before year end. But at
a committee hearing on Nov. 14, several Republicans charged that
FDA already had the authority to avoid the outbreak but failed
to, despite repeated problems at NECC.
On Oct. 17 the committee submitted a bipartisan request for
FDA documents relating to the outbreak including its dealings
with NECC and the Massachusetts pharmacy board that was the
primary regulator for NECC.
The latest letter to FDA contained no Democratic signatures.
House committee Democrats were not immediately available for
Republicans said a similar request to Massachusetts health
authorities produced thousands of internal state emails.
"FDA has provided the committee with zero. In fact, when
asked by committee staff on Nov. 16, FDA staff stated that they
had not even begun to search for responsive emails," their
The House approach to the issue of new regulation stands in
contrast with the Democrat-controlled Senate, where lawmakers on
both sides of the aisle have expressed a willingness to move
ahead with measures that could fundamentally change the
regulatory landscape for compounders.
The current outbreak is only the biggest and most recent
health problem linked to tainted compounded drugs, and Hamburg
has warned lawmakers that more outbreaks will occur if
regulations do not change.
The compounding pharmacy industry has waged successive
legislative and legal battles over the years to stave off
stricter federal regulations.