NORD's
Washington Office
 Read about events on Capitol Hill, funding for rare-disease research, and other topics of interest from NORD's office in Washington, DC.
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The Food and Drug Administration Safety Act of 2005 - SUMMARY
Senator Charles E. Grassley (R-IA) and Senator Christopher J. Dodd (D-CT)
April 27, 2005
The Food and Drug Administration Safety Act of 2005 (FDASA) will establish
an independent Center within the Food and Drug Administration (FDA) - the Center
for Post-market Drug Evaluation and Research (CPDER). The Director of the CPDER
will report directly to the FDA Commissioner, and will be responsible for conducting
risk assessment for approved drugs and biological products and ensuring their
safety and effectiveness once they are on the market.
FDASA will:
- Authorize the Director to require manufacturers to conduct post-market clinical
or observational studies if there are questions about the safety or efficacy
of a drug or biological product.
- Authorize the Director to determine whether an approved drug or licensed
biological product may present an unreasonable risk to the health of patients
or the general public, given the known benefits.
- Authorize the Director to take corrective action if a drug or biological
product presents an unreasonable risk to patients or the general public -
including the authority to make changes to the label or approved indication,
place restrictions on product distribution, require physician and consumer
education, and require the use of other risk management tools.
- Allow the Director to withdraw approval of a drug or biological product
if necessary to protect the public health.
- Require submission of advertising prior to dissemination, and certain advertising
disclosures related to risks and benefits to patients, if one or more of the
three following conditions is met: the Director has determined that the product
may present an unreasonable risk to patients, the product is the subject of
an outstanding post-market study requirement, or the product was approved
within the last two years.
- Establish strong enforcement mechanisms, including civil monetary penalties,
for those who fail to comply.
- Ensure that the Director benefits from all appropriate resources, including
consultation with the Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER), and makes all decisions
based on a risk-benefit analysis.
- Ensure that all findings and decisions made by CPDER are transparent.
- Require a report and recommendations to Congress on post-market surveillance
of medical devices.
- Authorize graduated appropriations totaling $500 million over five years
to ensure that CPDER has the resources to accomplish its goals.
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Since 1983, working toward the prevention, treatment, and cure of rare
“orphan” diseases.
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 In light of the current concern about bioterrorism, NORD is offering full-text versions of four disease reports - Anthrax, Smallpox, Botulism and Bubonic Plague - free of charge. Click here for your free copies.
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NORD Resource Guide
The new and expanded NORD Resource Guide
(5th edition) is now available. It lists more than 1,300 organizations helping
people with rare disorders.
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Medical Assistance Programs
NORD’s Medication Assistance Programs provide specific prescription drugs to people who cannot
afford them. (Go to Article)
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