For the most recent information on this topic, see FDA's Reinvention Initiatives Page on this Website.

See also: National Performance Review (April 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 products.

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:

• 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 manufacturing plants. 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 Impact: Industry will no longer be burdened with outdated requirements and FDA can regulate these products the same way it does other drugs.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 needs.
• 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 specific device. 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 marketed.
• 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 countries. Impact: Industry will have wider markets for its products and will be encouraged to maintain operations in this country.
• 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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