WASHINGTON _ An independent survey of drug,biotechnology and device manufacturers has produced areport that quantifies what many companies have reportedanecdotally: that inefficiencies and cost delays arisingfrom the FDA review and approval process are slowingthe progress of their products to market.

Some 120 Southern California companies participated inthe survey that includes data pertaining to more than 330product submissions. The survey was sponsored by theUniversity of California at San Diego's (UCSD)CONNECT program, a university-private sectorpartnership to link technology with outside opportunities.Price Waterhouse, of Costa Mesa, Calif., analyzed thesurvey results.

"The study is the first chance for the industry to tell theFDA what it's like to be a customer," said Bill Otterson,entrepreneur in residence at UCSD-CONNECT.

Otterson predicted that the report, "Improving America'shealth: a survey of the working relationship between thelife sciences industry and the FDA," will reach the deskof Vice President Al Gore. "Not only is Gore interested inthis study but the Small Business Administration islooking at it to improve the administration's relationshipwith the industry," he said.

Not An Indictment Of FDA

The report was the brainchild of Donald Grimm, formerCEO at Hyrbitech Inc., of San Diego, and now closelyinvolved with UCSD-CONNECT.

The report "is not an indictment of the FDA. It was anattempt to find out what was right and wrong with theindustry's day-to-day relationship with the FDA." Grimmviewed the report as complementary to the lobbying bytrade groups, such as the Biotechnology IndustryOrganization (BIO), which are seeking to persuadeCongress to enact legislation to streamline FDAregulation.

Grimm attributed much of the difficulty the industry ishaving to the FDA's abandonment of its central missionto ensure the safety and efficacy of drugs and medicaldevices. "Over the past years, the FDA has extended itsmission beyond the congressional mandate. At present,the FDA appears to view as part of its mission the need toensure that approved drugs and devices add to the `qualityof life' and are more effective than products currently onthe market, and are cost-effective," Grimm wrote in thereport.

The report provided findings on the industry'srelationship to the FDA in the following four areas:

* elements of the FDA approval process that, from thecompanies' viewpoint, contribute the most to delays inproduct review;

* the state of communications between the FDA and themedical products industry;

* the influence of the FDA approval procedures on theavailability and cost of products;

* plans to seek approval and/or set up manufacturingfacilities in other countries.

The surveyed companies cast a critical eye toward theFDA in general and were asked to focus their experiencespecifically with the centers for biologics, drugs anddevices. Far and away the Center for BiologicsEvaluation and Research (CBER) fared the best in thecomparisons. For example, while more than half of thebiotech and drug companies rated the FDA's submissionguidelines favorably, only a quarter of device companiesagreed.

Agency Guidelines Need To Be Revamped

The FDA should improve its written and oral guidelinesused at the outset and throughout the product reviewprocess and ensure that its requests for additional data are"clear, necessary and timely," according to the report.

On the other hand, it is critical that the companies submitclear, succinct, well-organized and complete submissions.The companies must "make serious efforts to determinewhat constitutes a good submission from the FDA's pointof view and not just their own," the report said.

Manufacturers need more incentives to submit qualityproduct applications, said Chris Nolet, national directorof Price Waterhouse's Life Sciences Industry Group.

"You would think that timely approval of their productwould prove to be incentive enough," he told BioWorldToday. "But the practical pressure of the capital marketsare forcing companies to balance the quality of thesubmission with the need to provide news of theirprogress to the capital markets." He recommended that ifthe submission was of high quality the company would beeligible for a rebate on its user fee. Conversely, ifsupplemental data had to be submitted, the companywould have to pay extra, Nolet said.

Most Communication With FDA Is Excellent, Quick

About half of the biotech companies said thecommunications with FDA were excellent while onlyabout a quarter of the drug and device firms rated them asexcellent. When asked to quantify the average responsetime for questions submitted to the FDA reviewers, mostcompanies received a response quickly, usually withinfive days. However, a quarter of the time it took onemonth or more to get a reply. Again, biotech companiesrated CBER as the easiest in terms of the degree ofdifficulty the company had in contacting their reviewerduring the approval process.

Presubmission meetings were rated highly by biotechfirms while drug and device companies did not find themto be that helpful. About a quarter of device firms foundthem to be of no help.

Many companies reported that changes in clinicalendpoints, toxicology, statistics and chemistry werefrequently required by the FDA during the approvalprocess. While biotech firms reported fewer problemswith the FDA on this issue, in about one third ofsubmissions the companies believed that thecommunication of changes by the FDA were not timely,presented up front or fairly communicated.

"It's clear from the survey results that biologicscompanies found the presubmission meeting with CBERto be helpful," said Nolet.

A larger proportion of the biotech companies and evenmore device firms found that the lack of clarity of FDArequests for additional information, clinical trials andanalyses impeded progress in about a quarter of allapplications. Turnover at the FDA was also cited asimpeding or stopping progress about one-third of thetime.

CBER rated high marks for the technical knowledge of itsreviewers and was cited as very helpful or helpful in morethan 70 percent of all cases.

Some Advice, Conclusions For The Agency

UCSD CONNECT urged the FDA to undertakemanagement reviews to focus on issues of structure andsubstance, especially clinical study endpoints, the studyrecommended. "The study offers the FDA an opportunityto embrace several management improvements," saidOtterson in an interview with BioWorld Today. "Theagency should be asking itself how it can fix the problemsbeing encountered by a large number of its customers."

Nolet urged companies to use electronic-mail on a regularbasis to improve communication with the FDA. "Eventhough a larger number of surveyed companies aremoving to electronic submissions, most are still usingletters to communicate with the FDA. That's prettyarchaic," he said.

Nolet urged the FDA to undertake the internalmanagement reviews that many companies haveembraced to address the changing realities of theirmarketplaces. "It's hard for a regulatory agency to re-engineer itself. But it's not impossible. CorporateAmerica has done it. There's no reason why the FDAcannot," he said. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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