For the most recent information on this topic, see FDA's Reinvention Initiatives Page on this Website.
April 5, 1995
Reinventing Drug and Medical Device Regulation
The Clinton Administration is committed to making government
work better by reducing unnecessary regulatory burdens while
maintaining the critical public health protections the
American people expect and deserve. In the case of the Food
and Drug Administration, reinvention of drug and medical
device regulation will mean speeding up the review of these
The high standards of the FDA have given Americans access to
drugs and medical devices that are safe and that work. In
addition, FDA has worked in recent years: to make new
therapies available as soon as possible, even before final
approval; to accelerate the approval of life-saving drugs;
and to speed up the review and approval of all drugs with
additional resources from industry user fees.
The Clinton Administration is building on these high
standards and efforts to speed up drug and device approval
with new FDA regulatory reforms. Some of these reforms will
directly speed up the review process for these products.
Others will reduce unnecessary regulatory burdens on
industry. All are aimed at maintaining and protecting
Americans' confidence in the safety and effectiveness of the
drugs they take and the medical devices they use.
FDA will reform drug and medical device regulation by:
Impact: Industry can modernize facilities and processes more
easily; FDA can shift resources to more critical review
- Allowing manufacturers of drugs and biologics
(products made from biological materials) to change the way
they manufacture an approved drug without FDA pre-approval
if the risk is negligible.
- Allowing manufacturers of biological drugs to get
licenses for pilot facilities instead of building full-scale
Impact: Manufacturers will have lower start-up costs and can
more quickly begin production of new drugs.
- Permitting greater flexibility in how distributors'
names appear on biological product containers, package
labels, and labeling.
- Impact: Small start-up companies, many of them
biotechnology firms, may more readily enter into
manufacturing arrangements with larger companies and bring
products to market quicker.
- Eliminating special requirements for manufacturing
insulin and antibiotic drugs.
Impact: Industry will no longer be burdened with outdated
requirements and FDA can regulate these products the same
way it does other drugs.
- Excluding drug and biologics manufacturers from
requirements for most environmental assessments.
Impact: Industry will be spared the expense of preparing
assessments that FDA has found unnecessary.
- Exempting up to 125 categories of low-risk medical
devices from premarket review, adding to the 441 categories
already exempted from review.
Impact: Industry will no longer have to wait for premarket
review, meaning that these devices can reach patients
sooner; FDA can shift resources to more critical review
- Eliminating the "reference list" and clarifying that
premarket review of medical devices can be affected only if
good manufacturing practice violations are related to a
Impact: Industry concerns that good manufacturing practice
violations for one product can slow down approval for other
devices unrelated to those problems will be alleviated, and
there will be more certainty about when products can be
- Developing a pilot program for the review of low to
moderate risk medical devices by outside organizations.
Impact: This program will help determine if such a system
can speed the review of these devices, whether the
independence of the review process can be maintained, and if
such a system will be less costly.
- Speeding the marketing of medical devices by charging
industry user fees to give FDA more resources for product
reviews and committing FDA to strict performance goals.
Impact: A similar program for prescription drugs has
substantially reduced review times and FDA has met all
performance goals to date.
- Expanding the opportunities for the export of
unapproved drugs and medical devices to industrialized
Impact: Industry will have wider markets for its products
and will be encouraged to maintain operations in this
- Clarifying the effectiveness standard for new drugs.
Impact: Industry will have a better understanding of how to
develop new products, reducing the time it takes to bring a
drug to FDA for review.
- Harmonizing international standards for the review of
drugs and medical devices.
Impact: The worldwide marketing of new products will be
speeded up if there is less need for duplicative testing to
meet the standards of different countries.
- Expanding and standardizing computer technologies used
by FDA in the review of new products and in the processing
of imported products.
Impact: Review times for new products will be reduced as
these technologies are better utilized both by FDA and
industry; imported products will be allowed into the U.S.
marketplace quicker as these systems are implemented.
(Hypertext amended by clb 1999-JAN-12)
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