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FOCR
Participates in Public Meeting on PDUFA
On
November 14th, 2005, Friends’ Chair Dr. Ellen Sigal
provided an advocacy perspective on the Prescription Drug
User Fee Act (PDUFA) at a public meeting held at the
National Institutes of Health. This legislation is set to
expire in September of 2007, and a concerted
reauthorization effort is expected.
According
to the FDA, this event marked the launch of the their
“public process toward reauthorization of PDUFA, the law
that allows the agency to help fund programs that have
helped product developers get early and frequent advice
about how to develop some of the last decades' most
innovative and important medicines.” The meeting included
a series of panels representing different stakeholder
interest groups, such as patient advocates, consumer
organizations, industry, health professionals and academic
researchers.
Congress
first passed PDUFA in 1992. The law’s original intent was
to provide FDA the power to collect user fees from
pharmaceutical manufacturers in order to generate
additional revenue necessary for hiring more reviewers and
support staff, and for upgrading its information
technology. Under the PDUFA approach, FDA is expected to
meet drug-review performance goals that emphasize
timeliness without altering or compromising its commitment
to ensuring that drugs are safe and effective before they
are approved. According to the GAO, PDUFA I facilitated
the addition of 700 full-time FDA employees. By 1996,
review times for drug applications had fallen from 20
months to 15 months.
PDUFA was
reauthorized for an additional five years in 1997 as part
of the Food and Drug Modernization Act (FDAMA). PDUFA II
increased the amount of the user fees and also added
provisions and performance goals regarding sponsor
interactions with the Agency. In addition, the goal for
reviewing a standard application was shortened from twelve
to ten months.
In 2002,
PDUFA was again reauthorized for an additional 5 years as
part of the Public Health and Security and Bioterrorism
Preparedness and Response Act of 2002. PDUFA
III gave FDA authority to expend PDUFA resources on risk
management and drug safety activities during the approval
process and during the first two to three years following
drug approval. According to the FDA, the
initiative to address drug safety for PDUFA III products
helps them better understand a drug's risk profile,
provide risk feedback to the sponsors and provide
essential safety information to patients and health
practitioners.
In their
press release for the November 14th meeting,
the FDA provided the following summary of PDUFA’s impact:
“Under
PDUFA, FDA has approved more than 1,000 new treatments
including: 62 new cancer drugs, 109 new drugs for
metabolic and endocrine disorders, 96 new anti-infective
drugs, 103 new drugs to treat neurological and psychiatric
disorders and 73 new drugs to treat cardiovascular and
renal disease. In addition, the median approval time for
priority review of new product applications decreased by
more than half -- from 13.2 months in 1993 to an estimated
six months in FY 2004. Over this same time period, the
median approval time for standard applications decreased
by more than 50 percent, from 22.1 months in 1993 to 10.5
months in FY 2004.”
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