FDA SPEEDS REVIEW OF NEW DRUG APPLICATIONS WITH ADOBE ACROBAT AND PDF.

The traditionally tedious and lengthy process of reviewing new drug applications (NDAs) is undergoing a sea change at the Food and Drug Administration (FDA). With the help of Adobe Acrobat and PDF, NDAs for everything from life-saving medications to basic over-the-counter treatments are being processed faster and more efficiently than ever, according to FDA officials, who say the benefits are undeniable.

FDA staff can now share information and review documents in minutes versus days, volumes of data are easier to manage and archive, consumers get faster access to medications, and drug companies can release medications sooner, increasing their daily revenues by millions of dollars.

Pharmaceutical companies submit thousands of NDAs annually to the FDA, with the hopes of introducing new drugs, changing recommended dosages, or marketing medications for different therapies. A typical NDA contains extensive pharmacology reports and results from clinical trials, often bound in as many as 1,000 volumes with 300 pages each.

"Adobe Acrobat and PDF support online access to NDA submissions that simplifies distributing, locating, and archiving this huge volume of data," says Greg Brolund, associate director for technology and policy for the Center for Drug Evaluation and Research at the FDA. "These efficiencies can help reduce the time to review NDA submissions and lower our processing costs."

Sources at Adobe say enhanced capabilities of Acrobat 4.0 promise to further streamline the FDA's processes. For example, new annotation features such as text highlighting and digital signatures will make it easier for FDA staff to share and view comments from other members of a review team, and determine who still needs to provide input. The ability to copy charts from PDF files on a PC to Microsoft Word or Microsoft Excel and view different versions of PDF files side by side will also streamline creation of review documents, which FDA reviewers create to highlight key findings in each NDA.

In late 1997, the FDA started giving pharmaceutical companies the option of submitting NDAs in Adobe PDF instead of on paper. Since then, the agency has received PDF submissions containing more than seven million pages in total.

For pharmaceutical companies, the advantages are many. First, the days or weeks needed to manually assemble hundreds of thousands of pages of research documents are eliminated. Second, photocopying and shipping costs, which can run upwards of $10,000 for a single submission, are cut substantially. And finally, more rapid approval on NDAs for critical medications can translate into increased revenue for pharmaceutical companies, sometimes at the rate of one million dollars per day.

The FDA plans to maintain indefinitely a PDF library of NDA submissions and review documents, giving it an easy-to-manage repository of drug history information, which is especially useful since drug manufacturers frequently submit changes -- for new dosages, different therapeutic applications -- to already approved medications.

As Brolund sees it, the increasing use of Acrobat and PDF is a natural extension of the agency's push for more streamlined operations. "Acrobat gives us a foundation for improving how we work today and in the future. When our reviewers can quickly find the information they need to make decisions, our service and effectiveness as a government agency go up considerably."