FDAMA Makes Favorable Progress

A report from FDA reveals successful efforts to educate patients and healthcare professionals, plus increased electronic filing and the development of regulations to promote clarity in labeling.

FDA recently sent a report to Congress outlining the progress that has been made since the introduction of the FDA Modernization Act of 1997 (FDAMA).

Among the accomplishments the agency cited are producing more and better information about new drug and medical device products for consumers and patients, clarifying and speeding up the process for reviewing and approving applications for new drugs and devices, implementing new inspection and postmarket monitoring procedures, and ensuring all parties involved have access to the best scientific and technical expertise. FDA has succeeded in some areas better than in others, the report acknowledges. Following are some of the report's points relevant to packaging and labeling.

Electronic Submissions. One initiative has been to promote the electronic filing of applications and reduce paper volumes. In fiscal year 1999, there was a 30% reduction in paper volume over fiscal year 1997, and the agency received 69 totally electronic submissions relating to manufacturing and packaging.

Consumer Education. In an effort to get more and better information out to consumers, the agency launched an educational program, "Take Time to Care," which encouraged patients to take their medication as prescribed. The program, conducted in October 1999, was a nationwide campaign encouraging women to educate themselves and their families about using medicines wisely. At its center was a brochure with four messages, including "Read the label," "Follow the regimen," "Ask your provider for more information," and "Keep a record of your medicines."

Drug Labeling Regulations. The agency also cited its new over-the-counter (OTC) drug labeling regulations, to take effect in 2002, as a significant accomplishment in the clarity-of-information initiative. "Americans buy about 5 billion OTC drugs each year . . . but they are not always clear on how to use them. Many older Americans also find the print on OTC labels too small to be legible," the report states. "FDA hopes the new 'Drug Facts' labels will improve the way consumers choose and use OTC medicines, just as the simplified 'Nutrition Facts' labels have helped consumers eat less fat and choose healthier diets."

The new format increases the minimum type size of the label print and employs other methods to improve readability, requires information to be presented in a standardized manner, and mandates simple language to communicate critical information. Industry has embraced the goals behind the effort, but has been critical of some aspects of the regulation, especially regarding exemptions for small packages.

Plant Inspections. The agency has not yet been able to meet its goal of increasing the frequency of inspections of domestic plants to make sure they meet all regulatory requirements, including those pertaining to the packaging process. Under FDAMA, 17,000 firms are required to be inspected at least every two years. In fiscal year 1999, only firms making biological products were inspected every two years or less. The average human drug product went 3.8 years between inspections, the average animal drug 4.0 years, and the average medical device 3.3 years. "While FDA regards statutory inspections as high priority, it believes it must rationally use its limited inspection resources by focusing on issues that pose the most serious public health risks," the report states. "FDA has focused education and outreach on local industries with a history of compliance problems and on firms that manufacture high-risk products. Firms have reported that these efforts give them a better understanding of FDA requirements." Despite falling short of this goal, FDA did develop the new "quality system inspection technique" for medical devices, which gives investigators greater flexibility in conducting inspections, and so far has reduced in-plant inspection time by 58% and overall inspection time by 44%.

Labeling. Labeling has been a factor in FDA's efforts to improve surveillance reporting of adverse events and postmarketing risk assessment. A new rule proposal would require drug manufacturers to submit adverse-event reports electronically, so the agency can process them faster and notify those potentially affected in a more timely manner. Depending on the seriousness of the issue, FDA can mandate a change in labeling.

Training Programs. As part of the agency's science and technology initiative, a series of industry training programs on new and emerging technologies have been held. One course covered the use of barrier isolation to sterilize drug products, and there are plans for one on new trends in sterility testing of medical devices.

The report can be viewed on-line.

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