WASHINGTON -- The U.S. House of Representatives and Senateare expected to approve supplemental appropriations for thePrescription Drug User Fee Act today.
"There is nothing controversial about it," Mary Jo Veverka,deputy commissioner for management and systems at the FDA,said on Thursday at a meeting between FDA officials andmembers of the press.
"We expect invoices to go out approximately two weeks afterthe supplemental appropriation is signed," said Veverka.
The user fee legislation was enacted last October to providefunds to streamline drug approval. FDA's goal is to reduce itsreview time from an average of 13 and a half months to 12months for "standard" product license, establishment licenseand new drug applications and "standard" efficacysupplements/amendments, and to six months on priority drugsand applications resubmitted following receipt of a non-approval letter, according to an FDA fact sheet.
Currently, however, many companies find their drugs rejectedat the end of the process. FDA also hopes to increase theapproval rate, Gerald Meyer, deputy director of the Center forDrug Evaluation and Research (CDER), told BioWorld.
Veverka said the FDA hoped to meet these goals for 90 percentof applications by fiscal year 1997. To this end, user fees willgo toward hiring 620 new employees, including 300 for theCenter for Biologics Evaluation and Research (CBER).
To anticipate the added workload, FDA obtained survey datawith help from the Biotechnology Industry Organization (BIO)and the Pharmaceutical Manufacturers Association (PMA) onbiologics and drugs under development quarter by quarter forthe next three years.
For this year, 120 applications have been submitted that willbe subject to user fees and another 30 are expected. The twocategories include a total of 47 biotechnology products.
The agency anticipates revenues of $36 million this year, risingto $84 million in 1997 for the five-year-long program.
"We are re-inventing the review process," said Veverka. Tokeep it simple, application processes for drugs and biologicshave been kept as similar as possible. "There are no particularareas of biotechnology that would be treated differently," saidVeverka.
The application payment schedule is:
-- Fifty percent payable at complete submission.-- Half of the sum returned if application not filed.-- Full 50 percent fee due upon resubmission.-- Remaining 50 percent payable within 30 days of FDA actionletter.
The fee will rise annually, from $100,000 this year to $233,000in 1997 for normal applications. The agency will offer waiversif "necessary to protect the public health" when the "feepresents a significant barrier to innovation," and under severalother circumstances.
The agency will soon schedule meetings for the industry on theEast and West coasts.
The survey data provided FDA with a window on wherecompanies are putting their efforts. "The industry is workingvery hard on products that affect the elderly," said Meyer.Neuropharmacology in particular "is a very busy area." Andsome new cardiovascular drugs -- "successors to ACEinhibitors" -- are in early stages of development.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.