Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published March 1998

REGULATORY FOCUS

FDA Reform Act Has Minimal Effect on Packaging

The act speeds the approval process for changes to drugs, devices, and biologic manufacturing, among other things, but has little to say about labeling or packaging.

FDA has been under siege for years to speed up the approval of new drugs and devices and to quickly implement new regulations such as the over-the-counter (OTC) labeling laws. Congress took steps on November 21, 1997, to prod the agency when it passed the FDA Modernization Act of 1997. The act promises to cut approval times for drugs and devices as well as for manufacturing changes.

For packagers, however, the act has little to offer except faster review times for products including packaging materials and containers. The act does, however, reauthorize the Prescription Drug User Fee Act of 1992 for five more years.

The act has also revised section 503(b) of the Federal Food, Drug, and Cosmetic Act to simplify the legend requirements for prescription drugs. Prescription drug labels are no longer required to bear the words, "Caution: Federal law prohibits dispensing without a prescription." New labels must now say, "Rx only." Additionally, the "Warning — May be habit forming" label previously required of habit-forming drugs is no longer needed. These new regulations took effect on February 19, 1998.

Also effective February 19, 1998, pharmaceutical and medical device manufacturers are now permitted to print "FDA-Approved" on product labels or in promotional materials. Such claims were previously prohibited under the Federal Food, Drug, and Cosmetic Act. According to Fenwick & West LLP, a law firm based in Palo Alto, CA, this revision should give U.S. manufacturers significant marketing advantages overseas.

Thanks to $329 million in user fees, FDA added nearly 700 employees to the drug and biologics program and cut the average review time from 30 to 15 months. The 1998 budget submitted by President Clinton calls for $132.3 million in user fees to be collected this year plus an additional $127.7 million in new fees from undetermined sources. The money is earmarked for postmarket surveillance, evaluation of medical devices, and review of generic and animal drugs.

FDA will use the $132.3 million in fees to be collected this year to hire 120 full-time employees to continue to improve review performance and to focus on measures designed to reduce the overall development time for drugs and biologics.

The new act codifies several initiatives including measures to modernize the regulation of biological products by bringing them into harmony with the regulations for drugs. It streamlines the approval processes for drug and biologic manufacturing changes and reduces the need for environmental assessment as part of a product application.

The new law abolishes the long-standing prohibition on manufacturers from disseminating information on unapproved uses of drugs and medical devices. The act allows a firm to distribute peer-reviewed journal articles about off-label uses of its product, provided the firm commits itself to file within a specified time frame a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use.

Medical device manufacturers have been FDA's most clamorous critics. Frustrated by slow approvals, they have pushed hard for reform. Packaging engineers also have felt hampered by slow progress on industry standards and regulations. The reform act addresses FDA's recent effort to focus its resources on medical devices, although no direct language discusses packaging or packaging materials. The law exempts from premarket notification Class I devices that are not intended for a use that is of substantial importance in preventing impairment of human health, or that do not present a potential unreasonable risk of illness or injury. Certain Class II devices are also exempt.

The law also directs FDA to focus its postmarket surveillance on higher-risk devices, and allows the agency to implement a reporting system that concentrates on a representative sample of user facilities that experience deaths and serious illnesses or injuries linked to device use.

The act specifies that FDA may bar from the market products that could present a serious health hazard because they are manufactured under conditions that do not comply with FDA regulations. The law also gives the agency authority to take appropriate action if the technology of a device suggests that it is likely to be used for a potentially harmful unlabeled use.