Kaiser Daily Health Policy Report Highlights Recent FDA-Related
Congressional Committee Actions

A number of congressional committees recently have taken action
related to oversight of FDA. Summaries appear below. Biotechnology
medications: House Energy and Commerce Committee Chair John Dingell
(D-Mich.) and committee member Bart Stupak (D-Mich.) last week sent a
letter to FDA Commissioner Andrew von Eschenbach to request
information about the failure of the agency to approve generic
versions of biotechnology medications, CQ HealthBeat reports.
According to CQ HealthBeat, "Democrats accuse the FDA of dragging its
feet on issuing a policy allowing approvals of generic versions of
costly drugs manufactured by the biotech industry." The letter asks
von Eschenbach to "state whether you believe your existing authority
is sufficient to accept and approve abbreviated applications for
biopharmaceutical drugs." The letter adds, "If not, please provide us
with a copy of any draft legislation that you believe is required to
facilitate the timely approval of these drugs" (Reichard, CQ
HealthBeat, 2/2). In addition, the committee has investigated "the
adequacy of resources devoted to the agency's Office of Generic
Drugs," CongressDaily reports (Johnson, CongressDaily, 2/2).

Domestic policy subcommittee: Rep. Dennis Kucinich (D-Ohio) will
chair the new House Oversight and Government Reform Domestic Policy
Subcommittee, which will focus on prescription drug safety at FDA,
CongressDaily reports. Kucinich said that House Oversight and
Government Reform Committee Chair Henry Waxman (D-Calif.) has told
him to "pursue the agenda that I want." In addition to prescription
drug safety at FDA, the subcommittee will focus on the availability
of affordable health care in urban areas, among other issues,
Kucinich said (Brady, CongressDaily, 2/2).

Food safety: The House Energy and Commerce Committee has begun an
investigation into FDA efforts to ensure food safety, CongressDaily
reports. In a recent letter to Von Eschenbach, Dingell, committee
ranking member Joe Barton (R-Texas) and other committee members write
that recent E. coli and salmonella outbreaks linked with fresh
produce "have raised serious questions about whether the FDA can
adequately protect the nation's food supply." According to the
letter, the budget for the FDA Center for Food Safety and Applied
Nutrition decreased by almost 50% in the last three years
(CongressDaily, 2/2).

Prescription drug safety: Senate Health, Education, Labor and
Pensions Committee Chair Edward Kennedy (D-Mass.) and ranking member
Michael Enzi (R-Wyo.) have reintroduced a bill that would provide FDA
with more authority to regulate prescription drugs after they have
reached the market, CQ HealthBeat reports. Kennedy said that the
bill, first introduced in the 109th Congress, would provide "a more
effective system to identify and assess the serious risks of drugs,
inform health care providers and patients about such risks and manage
or mitigate these risks as soon as they are detected." In addition,
the legislation would establish a public database of clinical trials
and also would screen FDA advisory committee members for financial
conflicts of interest, Kennedy said (Carey, CQ HealthBeat, 2/2).

Editorial
Lawmakers should "listen to what doctors have to say" about the
current FDA approval process "before they make valuable treatments
even harder to obtain," a Wall Street Journal editorial states.
According to the editorial, the September 2004 withdrawal of the COX-
2 inhibitor Vioxx prompted congressional "demands for tougher FDA
regulation and an explosion of litigation against the pharmaceutical
industry," but 80% of orthopedic surgeons surveyed in a recent poll
released by the Competitive Enterprise Institute said that the
medication should return to the market. Orthopedic surgeons "work
regularly with people suffering from chronic pain," and, because
they "know that almost all drugs have risks," they "see no sound
reason Vioxx should be ruled out as an option for patients who can't
find relief elsewhere," the editorial states. In addition, according
to the poll, 76% of respondents said that FDA approval process
is "too slow"; 60% said that "on balance" FDA regulations "hinder"
rather than help their ability to treat patients; and 70% said that
they support expanded access to experimental medications, the
editorial states. The editorial concludes, "This year promises to be
an important one for the FDA, with the complicated Prescription Drug
User Fee Act up for reauthorization and a number of senators urging
even stricter regulation under the guise of 'reform,' and lawmakers
should consider the opinions of physicians before they take action
(Wall Street Journal, 1/3).