The new drug safety board established by
the Food and Drug Administration to restore confidence
in the nation's drug supply will actually set back
efforts to improve the safety of the medications
Americans take and will not make it any easier to
take dangerous drugs off the market, an FDA whistle-blower
and a key senator said.
FDA safety officer David Graham said that
after reviewing the makeup and structure of the
Drug Safety Oversight Board, he concluded that the
panel is "severely biased in favor of industry"
and that "the FDA cannot be trusted to protect the
public or reform itself."
"Ironically, drug safety in the U.S. is worse
off today than it was in November," Graham added
in an interview. That was when Graham, a longtime
FDA safety reviewer, sharply criticized his agency's
record during a Senate Finance Committee hearing
into the abrupt withdrawal of the arthritis painkiller
Vioxx after a study found it had harmful heart effects.
Today, committee Chairman Charles E. Grassley
(R-Iowa) plans to issue his own critique of the
board. In a letter to acting Commissioner Lester
M. Crawford, Grassley said that the makeup of the
safety oversight panel led him to conclude that
"what we have here is nothing more than the status
Grassley's and Graham's criticisms indicate
that Congress may not be satisfied with the FDA's
steps and may press for action on pending legislation
to create a more independent drug safety office.
The FDA announced the 15-member board last
fall in part to identify and review emerging drug
safety issues that Graham and others said were not
being treated seriously enough; it was formally
established last month. It consists largely of FDA
managers, with some input from officials of the
National Institutes of Health and of the Department
of Veterans Affairs.
The attacks on the panel come as a steady
flow of bad news about safety problems with popular
drugs has given rise to competing initiatives designed
to reassure the public. The congressionally chartered
Institute of Medicine is holding a public meeting
today to begin an FDA-requested study of its safety
procedures, and Congress is considering bills that
would more aggressively address drug safety.
Other administration officials have also
proposed their own ideas. Last week, Medicare Administrator
Mark B. McClellan floated a plan to use billing
and health care information collected from Medicare
beneficiaries to create a more effective surveillance
system for prescription drugs on the market. The
current voluntary system for reporting serious drug
reactions is believed to capture only 10 percent
of actual cases. FDA officials said the initiative
looks promising and that they are working with Medicare
Janet Woodcock, FDA acting deputy commissioner
for operations, declined to respond to Grassley's
letter or Graham's comments, but she defended the
safety board as useful and independent. "The safety
board will be able to meet quickly, deliberate and
make some strong recommendations if needed," she
said. "They will be moving issues up and down on
the scale of urgency."
For Grassley and Graham, the big problem
with the safety oversight board is who will sit
on it. In his letter, Grassley said 11 of the 15
voting positions on the board are filled by senior
managers of the FDA's Center for Drug Evaluation
and Research, the same office responsible for reviewing
and approving new drugs. The safety board was established,
in part, to make the safety review process more
independent of the new drug review process -- an
acknowledgment of sorts that officials who approve
a drug for sale may be reluctant to see it taken
off the market because they tend to be more focused
on the potential benefits new drugs can bring.
Woodcock said the board will not include
any decision makers involved with individual drug
approvals and only a few of the supervisors who
oversee them. She said its members will not be beholden
to the drug center and will have little to do with
new drug approvals.
In his letter, however, Grassley asked: "Where
are the people responsible for post-marketing surveillance
who have allegiances only to post-marketing safety
and the public's well-being, and not to the drugs
that they helped put on the market in the first
He and Graham also criticized FDA's decision
to keep most of the board's safety deliberations
private, especially "at a time when the agency should
be making every effort to improve transparency and
accountability," Grassley said.
Graham noted that before he testified in
November, he turned down an invitation from Crawford
to play a central role in reorganizing the drug
safety program, fearing that it would constrain
his ability to criticize the agency.
A posting on the FDA Web site last month
confirmed that most of the board's members will
come from the center that evaluates new drugs, and
its executive director will be appointed by the
center's director. Any office can refer a drug safety
issue to the board's director, who, in consultation
with the center's deputy director, will decide whether
and when the board should address it.
The operating procedures of the board require
at least a two-thirds vote by its members to recommend
that the FDA take action.
Grassley and Sen. Christopher J. Dodd (D-Conn.)
have introduced a bill that would give drug safety
oversight responsibility to a board that would have
considerably more independence from FDA. Opponents
of the proposal, including the trade association
for the drug industry, say that they worry that
an independent board will focus exclusively on a
drug's risks and disregard its potential benefits.